Comparison of disposable anesthetic nasal mask and nasal cannula in elderly patients undergoing intravenous anesthesia for gastroscopy: a randomized controlled clinical trial

doi:10.21203/rs.3.rs-3203550/v1

Background

Elderly patients are prone to hypoxemia when they undergo gastroscopy under intravenous anesthesia due to their decreased physiological oxygen reserve capacity, increased sensitivity to drugs, etc. This study aimed to assess whether oxygen administration with the disposable anaesthetic nasal mask can lessen the incidence of hypoxemia in elderly patients during gastroscopy under intravenous anesthesia in comparison to a traditional nasal cannula.

Methods

A total of 300 patients were randomly assigned to oxygen administration by traditional double-chamber nasal cannula or disposable anesthetic nasal mask(n = 150 each). Primary outcome measures were the incidence of hypoxemia and severe hypoxemia. Secondary outcome measures included the duration of hypoxemia, lowest intraoperative SpO₂, the proportion of individuals who needed emergency airway management, the proportion of individuals discontinuing gastroscopy, the duration of operation, recovery time from anesthesia, the total dose of propofol, satisfaction of endoscopist, anaesthesiologist and patient, other adverse events.

Results

Compare with the nasal cannula group, the incidence of hypoxemia was significantly reduced (15.5% vs. 45.0%; P < 0.001), the lowest intraoperative SpO₂ was significantly increased (96.9% vs. 92.4%, P < 0.001), and the proportion of patients requiring emergency airway management was significantly reduced (13.5% vs. 37.6%; P < 0.001) in the anesthetic nasal mask group. There was only one patient (0.7%) requiring emergency suspension of endoscopy in the anesthetic nasal mask group, while there were 29 patients (19.5%; P < 0.001) requiring emergency suspension of endoscopy in the nasal cannula group. The satisfaction of the endoscopist, as well as anaesthesiologist in the anaesthetic nasal mask group, was significantly higher than in the nasal cannula group (P < 0.01). No major variations were observed in the incidence of severe hypoxemia, hypoxemia duration, duration of endoscopy, recovery time from anesthesia, the total dose of propofol, intraoperative adverse events, patient satisfaction, etc., between the two groups.

Conclusion

The use of an anesthetic nasal mask reduces the occurrence of hypoxemia during gastroscopy under intravenous anesthesia in elderly patients.

Trial registration:

ChiCTR2100053388, 20/11/2021.

Elderly patients

Hypoxemia

Gastroscopy

Nasal cannula

Gastrointestinal endoscopy (GIE) is a standard technique for detecting precancerous states and early cancers of the gastrointestinal tract and is a valuable method to treat and diagnose gastrointestinal diseases [1, 2]. With economic development and the improvement of health awareness, the annual number of patients receiving GIE has been increasing. A nationwide survey on the GIES status in mainland China showed that there are 14 million patients receiving GIES every year. Based on the growth rate of the aging population, it is estimated that the number of GIES in mainland China will reach 51 million by 2030 [3]. GIES may cause some adverse reactions, including nausea, vomiting, coughing, nervousness, fear, etc. Thus, many patients fail to cooperate well, resulting in an increased risk of potential perforation, bleeding, and even operation failure. Moreover, it reduces the quality of patient experience and compliance with endoscopy [4, 5]. With the introduction of comfortable medical care and rapid recovery, short-term intravenous anesthesia without endotracheal intubation not only reduces the pain of patients, improves their cooperation and satisfaction and provides good operating conditions for endoscopists but also makes patients rehabilitate quickly, therefore it has been widely used in GIES [6–8]. In China, 48.3% of GIES were performed under intravenous anesthesia, of which gastroscopy accounted for 47.9% [3]. In the United States, more than 6 million gastroscopy procedures are performed every year [9], and more than 53% of patients receive intravenous anesthesia [10].

Hypoxemia commonly occurs during gastroscopy performed under intravenous anesthesia [11, 12]. On the one hand, anesthetic drugs such as propofol can cause respiratory depression and airway obstruction [13, 14]. On the other hand, the gastroscope enters the esophagus and stomach through the oropharynx, which causes mechanical obstruction of the pharynx and compression of the trachea [15]. In addition, the gastroscope occupies the oropharyngeal passage, which makes it difficult for anesthesiologists to manage the airway. Preventing hypoxemia is very important because severe hypoxemia is fatal, requires emergency airway management and may lead to respiratory and cardiac arrest [16].

To prevent hypoxemia, patients undergoing painless gastroscopy are routinely given a continuous supply of oxygen [17, 18]. The methods for oxygen administration include a nasal cannula, face mask, nasopharyngeal airway, high-flow nasal cannula, supraglottic jet oxygenation, etc. The oxygen administration by a face mask is more suitable for colonoscopy because it often interferes with gastroscopy [19]. Although the nasopharyngeal airway can lower the occurrence rate of hypoxemia in obese patients under intravenous anesthesia, the placement of the nasopharyngeal airway is an invasive operation with a potential risk of airway damage [20]. Although the safety and effectiveness of high-flow nasal cannula [21] and supraglottic jet oxygenation [22] have been proven, they have a high cost and require special devices, which limit their applications. Therefore, the economical nasal cannula, which does not affect the operation of gastroscopy, is the most common oxygen administration method [23]. The oxygen administration by nasal cannula can solve the oxygen supply problem of most patients receiving gastroscopy. However, there is still a potential risk of hypoxia for high-risk patients with hypoxemia, such as the elderly [24] and obese patients [25], and patients with a history of apnea [26–28]. It has been reported that patients undergoing gastroscopy under intravenous anesthesia were given standard oxygen administration by nasal cannula, but 40% of patients still developed hypoxemia [29].

The traditional nasal mask is a mask-style airway tool that completely covers the nose [30]. Studies have shown that the continuous positive airway pressure by the nasal mask is effective in maintaining the upper airway patency and producing effective tidal volumes in comparison to a face mask [30]. Unlike the traditional nasal mask, the disposable anesthetic nasal mask used in this study (Jiangsu Nhwa Pharmaceutical Co., Ltd, China, Fig. 1A) does not completely cover the nose. However, it has two nasal prongs to block the nasal cavity. The nasal prong part is made of silicone, which is very soft and has a good fit to the nasal cavity eliminating the risk of damage to the nasal cavity. The applications of disposable anesthetic nasal masks in painless gastroscopy, especially in the elderly with a high incidence of hypoxemia, have not been reported yet. Therefore, a prospective, randomized controlled study was performed to compare anesthetic nasal masks with nasal cannulas in elderly patients under intravenous anesthesia. The safety, efficacy, adverse events, and satisfaction of endoscopists, anesthesiologists and patients of the two oxygen administration methods were evaluated.

Study design and participants

The Ethics Committee of The First Affiliated Hospital of Anhui Medical University approved this research (approval number: PJ2022-01-10). The trial was registered in the Chinese Clinical Trial Registry (ChiCTR2100053388, 20/11/2021) before enrollment of patients and complied with CONSORT (Consolidated Standards of Reporting Trials). All the enrolled individuals provided written consent.

This study is a prospective, randomized controlled clinical trial performed at The First Affiliated Hospital of Anhui Medical University. Elderly patients who planned to undergo gastroscopy under intravenous anesthesia were recruited from February 15, 2022, to September 6, 2022. The inclusion criteria of this study were as follows: males or females of age > 65 years, ASA physical status I – III, BMI 18.5-30 kg/m², undergoing gastroscopy under intravenous anesthesia; voluntarily participating in this trial and signing informed consent forms (ICFs). The exclusion criteria of this study were as follows: patients with severe cardiovascular and pulmonary diseases; patients who are allergic to anesthetic drugs; patients with nasal diseases such as rhinitis, nasal polyps and epistaxis; patients with acute pharyngitis and tonsillitis; patients with a history of myocardial infarction and unstable angina within the past six months; patients with severe obstructive sleep apnea syndrome; patients requiring a lot of water injection during endoscopy; patients requiring duration of operation for more than 1 hour; patients refusing to participate in this study.

Randomized controlled grouping

Individuals were randomly sorted into the disposable anesthetic nasal mask group or the nasal cannula group based on the computer-generated allocation list. The operator responsible for randomization was blinded to the study design, patient recruitment, and data collection. As the anesthetic nasal masks and nasal cannulas used in this study were easy to distinguish in appearance, anesthesiologists, endoscopists, patients, and data recorders knew the specific grouping. The statistician responsible for data statistics and evaluation of experimental results did not know the specific grouping.

Anesthesia Management

All individuals fasted for at least 8 h before the surgery. According to the requirements of gastroscopy, all individuals were to take 10 ml of oral dyclonine hydrochloride mucilage (Yangtze River Pharmaceutical Group Co., Ltd.) and 30 ml of pronase solution (Beijing Tide Pharmaceutical Co., Ltd.). After entering the room, the individual was administered with a venous channel and set in a left lateral position for standardized monitoring, including peripheral oxygen saturation (SpO₂), blood pressure, heart rate and electrocardiogram. To eliminate the impact of varied sedation schemes on the study results, a unified sedation scheme was used for patients who participated in this study. Patients were asked to take at least eight deep breaths with 100% oxygen for 60 seconds, then sufentanil (0.25 μg) was given intravenously, and 2 minutes later, propofol (1-2.0 mg/kg) was given for anesthesia induction. After the patient’s eyelash reflex disappeared, the gastroscope was implanted. The depth of sedation was estimated according to the MOAA/S scores (modified observer's assessment of alertness/sedation) by 0-5 points [31].The criteria: 5 points: quick response to calling names at a normal volume; 4 points: lethargy, response to calling names at a normal volume; 3 points: response to shouting the names; 2 points: response to mild stimulation or shaking; 1 point: response to the pain caused by squeezing the trapezius muscle; 0 points: no response to the pain caused by squeezing the trapezius muscle. During the operation, propofol was supplemented at 10-30 mg/time as needed to maintain the MOAA/S score at 2 or 3 points. If hypotension (MAP < 70 mmHg) occurred during the operation, fluid replacement and intravenous injection of ephedrine 5 mg were given to correct it; if bradycardia (HR < 50 beats/min) occurred, intravenous injection of atropine 0.5 mg was given.

Airway management

All individuals in the anesthetic nasal mask group received oxygen administration by disposable anesthetic nasal masks. The components of the anesthetic nasal mask include a mask body, a fixed headband, a connector, an end-tidal carbon dioxide detection connector, an extension tube, and two nasal prongs. With this design, the nasal masks allow monitoring of end-tidal carbon dioxide during surgery and provide oxygen delivery. Presently, there are three models for adult patients. According to the mask body size, nasal masks were divided into small sizes (model: AS-C-T), medium sizes (model: AM-C-T) and large sizes (model: AL-C-T). An anesthetic nasal mask with appropriate size should be able to seal the nasal cavity very well. After observing the size of the individual’s nasal cavity, the anesthesiologist selected an appropriate model and fixed it with a headband (Fig. 1A). The connectors of anesthetic nasal masks were connected to the breathing circuit of the anesthesia machine, and the initial oxygen flow rate was 5 L/min.

All patients received oxygen administration with standard double-chamber nasal cannulas in the nasal cannula (Fig. 1B), with an initial oxygen flow rate of 5 L/min.

If SpO₂ was ≤ 92% during the operation, an intervention was performed according to the following procedures in sequence: firstly, increase the oxygen flow rate to 10 L/min. Secondly, lift the patient’s lower jaw. Thirdly, remove the gastroscope and perform face mask ventilation in the nasal cannula group; in the anesthetic nasal mask group, perform nasal mask ventilation, and if hypoxemia did not improve, then face mask ventilation was performed. Fourthly, endotracheal intubation for mechanical ventilation was performed. Details are shown in Fig. 2, Hypoxemia Treatment Process.

Outcome measures

The primary outcome measure was the incidence of hypoxemia and severe hypoxemia. In the current research, hypoxemia (desaturation) was described as SpO₂ ≤ 92% and duration < 60 s. Severe hypoxemia was defined as intraoperative SpO₂ ≤ 75% at any time or duration of hypoxemia ≥ 60 s.

The secondary outcome measures included the following:

1. Duration of hypoxemia (seconds) and lowest intraoperative SpO₂.

2. Proportion of patients requiring emergency airway management, defined as hypoxemia that cannot be corrected by increasing oxygen flow and needs to be corrected by jaw lifting, nasal mask ventilation, face mask ventilation, or even endotracheal intubation.

3. Proportion of patients discontinuing gastroscopy refers to the proportion of patients who need to stop the operation urgently, remove the gastroscope body, and perform face mask-assisted ventilation or endotracheal intubation.

4. Relevant time indexes (minutes), including the duration of operation and recovery time from anesthesia. The duration of operation was described as the duration from inserting the endoscope into the oral cavity to removing it after the completion of the operation. The recovery time from anesthesia was defined as the time when the MOAA/S score was 5 points, and the corresponding sedation depth was a quick response to calling names at normal volume [31].

5. Total dose of propofol.

6. Occurrence of adverse events, including cough, hiccups, laryngospasm, epistaxis, dry nose, sore throat, nausea and vomiting etc.

7. Satisfaction: At the end of the operation, the endoscopist and the anesthesiologist were asked to evaluate their satisfaction, respectively. In contrast, patients were asked to evaluate their satisfaction before leaving the consulting room. The full score was 100 points, and a score ≥ 90 points were defined as complete satisfaction [32].

Sample size

The sample size was determined by the software Pass 11.0 (NCSS, LLC, Kaysville, Utah, USA). Reports suggest that the occurrence of hypoxemia is as high as 40% in individuals undergoing gastroscopy under intravenous anesthesia [29]. Assuming that anesthetic nasal masks can decrease the occurrence of hypoxemia from 40% to 20%, the minimum sample size calculated was 109 in each group (α = 0.05, power = 0.9). If the dropout rate was 10%, the minimum sample size required was 242 (121 in each group). In this study, 300 patients were included, which was greater than the minimum sample size.

Statistical analysis

Statistical analyses were conducted using SPSS 23.0. The quantitative data of normal distribution was depicted by mean ± standard deviation (SD), and the difference of the groups were compared by Student's t test. The quantitative data of skewed distribution were depicted by Median (P25, P75), and the groups were compared by the Mann-Whitney U test. The qualitative data were depicted by frequency. The groups were compared by Chi-square test or Fisher's exact tests. The ranked data groups were compared by the Mann-Whitney U test. P < 0.05 was taken as a statistically significant value.

Patient Features

In total, 300 elderly individuals underwent gastroscopy under intravenous anesthesia from February 15, 2022, to September 6, 2022, and they were randomly sorted into two distinct groups (anesthetic nasal mask group or nasal cannula group). Two individuals in the anesthetic nasal mask group and one in the nasal cannula group were eliminated from the analysis of this study due to missing data (Fig. 3). All patients tolerated the procedure well, and no serious complications such as myocardial infarction, cerebrovascular accident, or death occurred.

In this study, no significant statistical differences were seen in the age, gender ratio, BMI, ASA class, Mallampati class, baseline SpO₂, SpO₂ before sedation, complications, etc., between the two groups (Table 1).

Primary and Secondary Outcomes

The overall occurrence of hypoxemia in this research was 30.3% (90 of 297 patients). The occurrence of hypoxemia in the anesthetic nasal mask group (15.5%) was notably lower than that in the nasal cannula group (45.0%; P < 0.001; Table 2). Therefore, the risk of hypoxemia was reduced by 29.5% by the anesthetic nasal masks. No major variations were seen in the occurrence of severe hypoxemia (4.7% vs. 9.4%, P = 0.12) and duration of hypoxemia (30 seconds vs. 25 seconds, P = 0.487) between the nasal cannula group and the anesthetic nasal mask group. However, the lowest intraoperative SpO₂ in the anesthetic nasal mask group was remarkably enhanced than that of the nasal cannula group (96.9 % vs. 92.4%, P < 0.001; Table 2).

In this study, the proportion of individuals who needed emergency airway management was 25.6% (76 of 297 patients). The proportion of individuals needing emergency airway management in the anesthetic nasal mask group (13.5%) was remarkably lower than that in the nasal cannula group (37.6%; P < 0.001; Table 2). The proportion of individuals who improved hypoxemia with increased oxygen flow (15.5% vs. 45.0%; P < 0.001) and mandibular thrust manipulation (13.5% vs. 37.6%; P < 0.001) in the anesthetic nasal mask group was significantly lower than that in the nasal cannula group. Additionally, in the anesthetic nasal mask group, nasal mask ventilation was used in 15 patients (10.1%), and only one patient (0.7%) required emergency suspension of endoscopy and the use of face mask ventilation, while in the nasal cannula group, there were a total of 29 patients (19.5%; P < 0.001; Table 2). No patient required endotracheal intubation to improve hypoxemia in this study.

No statistical differences were noted in the duration of endoscopy, recovery time from anesthesia, the total dose of propofol and intraoperative adverse events between the two groups. Both endoscopist satisfaction and anesthesiologist satisfaction in the anesthetic nasal mask group were significantly higher than in the nasal cannula group (P < 0.01). Nevertheless, no statistical difference was observed in patient satisfaction across the two groups (Table 3).

Due to the aging population, the number of elderly patients requiring for GIE is increasing, which brings severely challenges to clinical management. Previous studies have shown that advanced age increases the incidence of hypoxemia during anesthesia in endoscopic surgery [33, 34], which is one of the independent risk factors for serious complications in endoscopic surgery [35]. Elderly patients often have cardiopulmonary diseases, which make their physiological oxygen reserve capacity poor [36]. Additionally, due to many factors such as economic costs, examination cycle, and shortage of medical resources, there is a lack of relevant preoperative examinations, including routine blood tests, liver and kidney functions, cardiopulmonary functions, etc., which make anesthesiologists fail to assess the conditions of elderly patients in a comprehensive and detailed manner. In contrast, elderly patients are more sensitive to sedatives [3] and are prone to airway-related complications such as respiratory depression and airway obstruction. Moreover, the elderly have poor tolerance to hypoxia, which will lead to serious consequences if it is not improved effectively and timely. In addition, anesthesiologists and endoscopists share the oropharyngeal passage during gastroscopy, which makes it impossible for anesthesiologists to perform effective airway management. Therefore, providing satisfactory anesthesia and rapid recovery for elderly patients is an important issue in protecting the airway safety of elderly patients during gastroscopy diagnosis and treatment. In this study, oxygen administration by disposable anesthetic nasal masks was performed to improve the quality of anesthesia for elderly patients undergoing gastroscopy.

The overall occurrence of hypoxemia in this research was 30.3%, indicating that hypoxemia events are very common in patients under intravenous anesthesia [11, 12]. This study showed that the incidence of hypoxemia in the nasal cannula group was 45.0%, which was higher than the result (40%) in the study by Adam B et al [29]. The possible reason is that elderly patients (age: 72.1 ± 4.5 years) were used in this study, while the patients in the study by Adam B et al. were relatively young (age: 54.5 ± 16.2 years). In the study by Dong Xu Chen et al., the incidence of hypoxemia in the nasal cannula group was only 27.7% [32]. The variations in the outcomes may be attributed to the use of varied sedation programs, the difference in study populations, and, most importantly, the different definitions of hypoxemia. Hypoxia in elderly patients is prone to serious complications. In this study, out of consideration for the safety of elderly patients, active management was performed when SpO₂ was ≤ 92%, but the hypoxemia was defined as SpO₂ ≤ 90% in a report by Dong Xu Chen et al.

The study results showed that, compared with the individuals in the traditional nasal cannula group, the incidence of intraoperative hypoxemia was significantly reduced (15.5% vs. 45.0%), and the lowest intraoperative SpO₂ was significantly increased (96.9% vs. 92.4%) in the elderly patients who were given disposable anesthetic nasal masks. This effective change may be attributed to the following facts: the anesthetic nasal mask sealed the patient's nasal cavity very well, thereby providing a higher concentration of oxygen supply, and it provided a sustained positive airway pressure, which was considered an effective method of treating hypoxemia [37]. Another advantage of the anesthetic nasal masks is that the airway of the patient and the anesthesia machine form a closed circuit after fixation, which provides favorable conditions for non-invasive mechanical ventilation. Therefore, for elderly patients who develop severe hypoxemia during the operation, the anesthetic nasal masks can provide non-invasive mechanical ventilation without affecting the operation of the endoscopists, thereby protecting the airway safety of the patients comprehensively.

Anesthetic nasal masks remarkably decreased the proportion of individuals who needed emergency airway management (13.5% vs. 37.6%). Some measures were taken, such as simple anesthesia management, for example, increasing the oxygen flow and providing jaw thrust maneuver and anesthetic nasal mask-assisted ventilation without affecting the operation of the endoscopists. These measures can improve hypoxia, thus significantly reducing the use of face mask ventilation and the incidence of emergency airway management that interrupts or stops gastroscopy. The incidence of airway intervention and interruption of endoscopic procedures was significantly reduced, which might be the reason for the higher satisfaction of endoscopists and anesthesiologists in the anesthetic nasal mask group. No major variation was observed in the incidence of adverse events between the two groups, and the use of anesthetic nasal masks did not increase complaints of postoperative pain and complications of nasal discomfort. The results of this study suggested that anesthetic nasal masks are an effective and safe oxygen administration method for elderly patients undergoing gastroscopy.

This study has certain limitations. Firstly, the sample size is limited, and there is a lack of a large sample size and multiple centers for further verification. Secondly, the included studies were mainly elderly outpatients who lacked objective examinations, such as blood routine, lung CT, lung function, etc. Therefore, the influence of anemia and lung diseases cannot be ruled out. Thirdly, in order to have a better endoscopic vision for gastroscopy, air will be injected into the esophagus and gastric body during the examination. Therefore, whether nasal mask ventilation increases the risk of gastric distention and aspiration in patients cannot be effectively observed. In the future, this issue will be further studied by other endoscopic operations such as colonoscopy and hysteroscopy.

The design of the disposable anesthetic nasal mask allows the monitoring of end-tidal carbon dioxide, which may be beneficial to the early detection of hypoventilation in patients and reduce the incidence of hypoxemia [26–28]. However, due to the lack of corresponding equipment in the consulting room, carbon dioxide monitoring was not implemented in this study. Further study will be performed on the feasibility of a nasal anesthetic mask for end-tidal carbon dioxide monitoring.

In conclusion, the outcomes of this research showed that the use of anesthetic nasal masks would not increase adverse reactions for elderly patients undergoing gastroscopy and would be more conducive to protecting the airway safety of patients, including reducing the incidence of hypoxemia and the lowest intraoperative blood oxygen value, reducing the incidence of suspension of endoscopic operations, etc., and significantly improve the satisfaction of endoscopists and anesthesiologists. Therefore, disposable anesthetic nasal mask can be used as an effective oxygen administration method during intravenous anesthesia for elderly patients in gastroscopy operations.

Acknowledgements

We gratefully acknowledge Editage for English language editing and Jiangsu Nhwa Pharmaceutical Co., Ltd, of China for providing disposable anesthetic nasal masks for this study.

Authors’ contributions

All authors were participated in the study design, planning, study conduct, data curation and analysis, drafting and revision of the manuscript. All authors read and approved the final manuscript.

Funding

This study was supported by the Science Research Fund of colleges and universities in Anhui Province of China (grant number 2022AH051187) and the Research Fund Project of Anhui Medical University (grant number 2022xkj140; grant number 2022xkj148).

Availability of data and materials

Data are available from the corresponding author on reasonable request.

Ethics approval and consent to participate

This study was approved by the Ethics Committee of the First Affiliated Hospital of Anhui Medical University (approval number: PJ2022-01-10) and registered in the Chinese Clinical Trial Registry (ChiCTR2100053388, 20/11/2021). The study protocol followed the CONSORT (Consolidated Standards of Reporting Trials). All methods were carried out in accordance with relevant guidelines and regulations. Written informed consent was obtained from all participants.

Consent for publication

Not applicable.

Competing interests

The authors have no conflicts of interest to declare.

Author details

¹Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, People’s Republic of China. ²Department of First Clinical Medical College of Anhui Medical University, Hefei, Anhui, People’s Republic of China.³Department of Epidemiology and Health Statistics, Anhui Medical University, Hefei, Anhui, People’s Republic of China.

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Table 1. Patient characteristics

Characteristic	Anesthetic Nasal Mask （n＝148）	Nasal Cannula （n＝149）	p value
Age (yr)	72.6 ± 5.4	72.1 ± 4.5	0.44
Sex (M/F)	87/61	82/67	0.51
BMI (kg/m²)	23.0 ± 2.9	22.9 ± 2.9	0.83
ASA physical status (Ⅰ/Ⅱ/Ⅲ)	1/116/31	2/121/26	0.39
Mallampati class (1/2/3/4)	53/83/8/4	51/86/9/3	0.82
Baseline SPO₂ (median IQR, %)	97.0 (96.0 to 98.0)	97.0 (96.0 to 97.0)	0.745
SPO₂ before sedation (median IQR, %)	100.0 (100.0 to 100.0)	100.0 (100.0 to 100.0)	0.127
Comorbidities	99 (48.8)	104 (51.2)	0.59
Hypertension	63 (42.6)	62 (41.6)	0.87
Diabetes	10 (6.8)	17 (11.4)	0.16
Ischaemic heart disease	17 (11.5)	13 (8.7)	0.43
History of cerebral infarction	5 (3.4)	11 (7.4)	0.13
Chronic bronchitis	1 (0.7)	0 (0)	0.32
COPD	1 (0.7)	1 (0.7）	1.0
Asthma	1 (0.7)	0 (0)	0.32
History of partial lung resection surgery	1 (0.7)	0 (0.7)	0.32
Two or more comorbidities	26 (17.6)	19 (12.8)	0.25
Data are expressed as mean ± SD or number of patients (% of group total) or median IQR. IQR, interquartile range; BMI, body mass index; ASA, American Society of Anesthesiologists; SpO₂, peripheral oxygen saturation; COPD, chronic obstructive pulmonary disease.

Table 2. Incidence of hypoxaemia and need for airway assistance

Characteristic	Anesthetic Nasal Mask （n＝148）	Nasal Cannula （n＝149）	p value
Primary outcome
Incidence of hypoxemia	23 (15.5)	67 (45.0)	＜0.001
Incidence of severe hypoxemia	7 (4.7)	14 (9.4)	0.12
Secondary outcomes
The duration of hypoxemia (median IQR, s)	30 (18.0 to 63.0)	25.0(17.0 to 45.0)	0.487
Minimum SPO₂ (median IQR, %)	99.0(97.0 to 100.0)	94.0 (88.0 to 98.0)	＜0.001
Increase the flow of oxygen	23 (15.5)	67 (45.0)	＜0.001
Jaw thrust	20 (13.5)	56 (37.6)	＜0.001
Anesthesia nose mask ventilation	15 (10.1)	0
Mask ventilation	1 (0.7)	29 (19.5)	＜0.001
Tracheal intubation	0	0
Emergency airway management	20 (13.5)	56 (37.6)	＜0.001
Incidence rate of discontinuing gastroscope operation	1 (0.7)	29 (19.5)	＜0.001
Data are expressed as number of patients (% of group total) or median IQR. IQR, interquartile range; SpO₂, peripheral oxygen saturation.

Table 3. Related time measures, propofol dose, adverse events and satisfaction

Characteristic	Anesthetic Nasal Mask （n＝148）	Nasal Cannula （n＝149）	p value
Duration of procedures (median IQR, min)	6.0 (4.0 to 8.0)	5.0 (4.0 to 7.0)	0.153
Recovery time (median IQR, min)	3.0 (1.0 to 4.0)	3.0 (1.0 to 4.0)	0.721
Total dose of propofol(median IQR, mg)	110 (90 to 120)	110 (95 to 120）	0.891
Total adverse events	35 (23.6)	37 (24.8)	0.81
Cough	23 (15.5)	23 (15.4)	0.98
Hiccups	2 (1.4)	3 (2.0)	0.66
Laryngospasm	0	0
Epistaxis	0	0
Dry nose	1 (0.7)	3 (2.0)	0.32
Sore throat	4 (2.7)	4 (2.7)	0.99
Nausea and vomiting	2 (1.4)	2 (1.3)	1.0
Other adverse events	3 (2.0)	2 (1.3)	0.65
The satisfaction of gastroenterologists	139 (93.9)	127 (85.2）	0.014
The satisfaction of anesthetist	140 (94.6)	131(87.9)	0.042
The satisfaction of patient	145 (98.0)	146 (98.0)	0.993
Data are expressed as number of patients (% of group total) or median IQR. IQR, interquartile range.

No competing interests reported.

Comparison of disposable anesthetic nasal mask and nasal cannula in elderly patients undergoing intravenous anesthesia for gastroscopy: a randomized controlled clinical trial

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Abstract

Background

Methods

Results

Conclusion

Trial registration:

Figures

Introduction

Materials and Methods

Results

Discussion

Conclusion

Declarations

References

Tables

Additional Declarations

Status:

Version 1