CT 3-Dimentional Airway Reconstruction-guided Intraluminal Placement of Endobronchial Blocker in Pediatric Patients: A Randomized Controlled Study

doi:10.21203/rs.3.rs-46104/v1

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CT 3-Dimentional Airway Reconstruction-guided Intraluminal Placement of Endobronchial Blocker in Pediatric Patients: A Randomized Controlled Study

https://doi.org/10.21203/rs.3.rs-46104/v1

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Background: The one-lung ventilation (OLV) with endobronchial blocking is commonly used in anesthesia for pediatric thoracic surgery. Bronchoscopy is commonly used to guide the endobronchial blocker placement. However, when bronchoscopy is not applicable, the proper placement of endobronchial blocker is challenging. The computed tomography (CT) 3-dimentional reconstruction may be used to accurately measure the airway of pediatric patients. The present study was aimed to propose a new approach of CT 3-dimentional airway reconstruction-guided endobronchial blocker placement in pediatric patients and to determine its efficiency in clinical application.

Methods: A total of 127 pediatric patients of 0.5-3 years old who would undergo elective thoracic surgery under OLV were randomized into the bronchoscopy group and the CT group. The degree of lung collapse, postoperative airway mucosal injury, pulmonary infection within 72 h after surgery, trachyphonia after tracheal extubation, durations of postoperative mechanical ventilation, intensive care unit (ICU) stay, and hospitalization, the successful rate of the first blocker positioning, and the required time and repositionings for successful blocker placement were compared between the two groups.

Results: The degree of lung collapse, postoperative airway mucosal injury, pulmonary infection within 72 h after surgery, trachyphonia after tracheal extubation, durations of postoperative mechanical ventilation, ICU stay, and hospitalization were similar between the two groups (all P > 0.05).

Conclusions: For pediatric patients who would undergo surgery with OLV, preoperative CT 3-dimentional airway reconstruction could be used to guide endobronchial blocker placement, with a blocking efficiency similar to that of bronchoscopy-guided blocker placement.

The trial was registered prior to patient enrollment at China Clinical Trial Registry (http://www.chictr.org.cn/showproj.aspx?proj=4344, Principal investigator: Yingyi Xu, Registration number: ChiCTR-TRC-14005232, Date of registration: 12 August 2014).

Anesthesiology & Pain Medicine

endobronchial blocker

pediatric anesthesia

CT 3-dimentional reconstruction

one-lung ventilation

bronchoscopy

Question: How to improve the successful rate of endobronchial blocker placement in pediatric patients when bronchoscopy is not applicable?

Finding: The blocking efficiency of computed tomography (CT) 3-dimentional airway reconstruction-guided endobronchial blocker placement was similar to that of bronchoscopy-guided blocker placement.

Meaning: When bronchoscopy is not applicable, preoperative CT 3-dimentional airway reconstruction could be used to guide endobronchial blocker placement in pediatric patients.

Conflict of Interest Statement

None of the authors have any financial conflicts of interests. This work was not supported by any grants.

During anesthesia for thoracic surgery, one-lung ventilation (OLV) is very important because lung isolation is necessary for most thoracic surgeries to ensure clear surgical exposure ^1,2. For pediatric patients, several OLV techniques are available, including double-lumen tube and bronchus blocking ³. However, conventional double-lumen tube and UniventTM blocker are not suitable for infants and young children due to their large external diameters ⁴, whereas the double-lumen tube (Marraro) designed for newborns and infants are not widely adopted yet ⁵. Bronchial blocking is the most commonly used OLV technique for pediatric patients. Quick and proper blocker placement is the key of OLV, and bronchoscopy (BRO) is commonly used to guide endobronchial blocker placement in pediatric patients ⁶. The blocking techniques include intraluminal and extraluminal blocking. For extraluminal blocking, the bronchial blocker and Tracheal tube need to be inserted together through the glottis and may cause airway mucosal injury with a high rate of postoperative traumatic laryngitis, and the bronchial blocker is hard to be fixed and is prone to move during surgery ^7,8. Intraluminal blocking causes less injury with certain blocking efficiency, but the application of bronchoscopy-guided positioning is limited by the diameter of the Tracheal tube for pediatric patients ⁹. Only the Tracheal tube with an internal diameter greater than 4.5 mm could allow the simultaneous insertion of the bronchoscope and the finest bronchial blocker. Bronchoscopy-guided intraluminal blocking cannot be applied in pediatric patients who are too young or have a narrow airway that cannot allow the insertion of a Tracheal tube with an internal diameter greater than 4.5 mm. In addition, for institutions without fiberoptic bronchoscopy, such as some institutions in developing countries, how to properly place the endobronchial blocker in pediatric patients remains challenging.

Chest CT images could be used to accurately predict the optimal insertion depth of double-lumen Tracheal tube ¹⁰ and guide extraluminal Uniblocker placement in the left bronchus in adult patients ¹¹. However, the airway anatomy is different between children and adults. In addition, the existence of abnormal take off of the right upper lung lobe makes the endobronchial blocker placement in the right bronchus harder than that in the left bronchus. Whether chest CT images could be used to guide endobronchial blocker placement in pediatric patients remains to be determined. We proposed a novel method of applying CT 3-dimentional reconstruction to measure the airway and guide endobronchial blocker placement in pediatric patients. In the present randomized prospective study, we compared the efficiency of endobronchial blocker placement guided by bronchoscopy and CT 3-dimentional reconstruction and determined the feasibility of applying preoperative helical CT 3-dimentional airway reconstruction to guide endobronchial blocker placement in pediatric patients.

Patient enrollment and randomization: This study was approved by the institutional ethical committee of Guangzhou Women and Children’s Medical Center (No. 2014051229, approval date: June 3, 2014). The trial was registered prior to patient enrollment at China Clinical Trial Registry (http://www.chictr.org.cn/showproj.aspx?proj=4344, Principal investigator: Yingyi Xu, Registration number: ChiCTR-TRC-14005232, Date of registration: 12 August 2014). Written informed consent was obtained from all patients enrolled in the study. Informed consent was signed by the guardians of each patient. Pediatric patients who would undergo elective thoracic surgery between September 2014 and June 2016 at Guangzhou Women and Children’s Medical Center were selected. The enrollment criteria were as follows: (1) ASA stage I-III and (2) age of 0.5-3 years old. The exclusive criteria were as follows: (1) airway compression; (2) laryngeal edema or acute airway inflammation; (3) abnormal takeoff of the right upper lung lobe; (4) foreseeable difficulties in endotracheal intubation. The enrolled patients were randomized into the bronchoscopy (BRO) group and the CT group using the closed envelope technique. The endobronchial blocker placement was guided by bronchoscopy in the BRO group and by CT 3-dimentional airway reconstruction in the CT group. All cases of anesthesia were performed by a pediatric anesthetist with 6-year experience of thoracic anesthesia. Random numbers were generated using software (SAS 9.2, SAS Institute Inc, Cary, NC, USA) with a ratio of 1:1. These numbers were then sealed in envelopes and kept by an independent study coordinator who did not participate in anaesthesia, perioperative care and postoperative follow-up of the patients. During the study period, patients were consecutively recruited and randomly divided into the control or intervention group accordingly. Anaesthesiologists who gave anaesthesia did not participate patients’ follow up and data collection. Patients, healthcare providers and investigators who were in charge of follow-up and data collection, were blinded to the study protocol.

CT measurement: All pediatric patients received cervical and chest CT scanning (5 mm thickness, 5 mm interval, Aquilion 64, Toshiba) under sedation at the supine position for 3-dimentional airway reconstruction before surgery. The FH plane was determined with the bilateral auriculares and the orbitale; the median vertical plane was determined with the middle of sella turcica, the nasospinale, and the posterior edge of foramen magnum. The distance from the incisor teeth to the carina was measured at the vertical plane when the airway between the incisor teeth and the carina was clearly exposed ; if the patient was not at a proper position or the airway was compressed, the distance would be measured after surface reconstruction (Figure 1).

Anesthesia: All pediatric patients received intravenous injection of 0.01 mg/kg penehyclidine hydrochloride before surgery and oxygen inhalation after entering the operation room. They received micro-pump infusion (8-10 ml/kg/h) of sodium acetate Ringer's injection, and their BP, HR, ECG, and SpO₂ were monitored. Midazolam (0.05 mg/kg), sufentanil (0.3 μg/kg), and rocuronium (0.6 mg/kg) were injected intravenously to induce general anesthesia. Then, an tracheal tube without side holes (Weili Medical Inc, Guangzhou, China) was intubated under direct vision of laryngoscopy. The catheter model was selected according to the calculation using the classic formula (based on predicted age formula). After intubation, the partial pressure of carbon dioxide in endexpiratory gas (PETCO₂) as well as invasive arterial blood pressure and central venous pressure were monitored, and tracheal aspiration was performed. Inhalation of 1%-3% sevoflurane was used for anesthesia maintenance with a tidal volume of 6-8 ml/kg. The concentration of sevoflurane was adjusted according to hemodynamic changes and data of anesthesia monitoring. Rocuronium and sufentanil were supplemented while necessary. All patients were subjected to ICU care after surgery.

Endobronchial blocker placement: In the BRO group, the insertion depth of tracheal tube was calculated using the classic formula¹². After the 5 French (5F) Weili endobronchial blocker (Weili medical Inc, Guangzhou, Guangdong, China) was placed into the tracheal tube, an electrobronchoscope (A20-2.8, Maidehao Co, Zhuhai, Guangdong, China) with a diameter of 2.8 mm was inserted to help locate the endobronchial blocker until the point A of endobronchial blocker reached the take off of the main bronchus at the blocking side (Figure 2). The proper blocker placement was confirmed under bronchoscopy after the patients shifted from the horizontal position to the lateral position.

In the CT group, CT 3-dimentional reconstruction images were used to measure the length of the main bronchus (the length from the incisor teeth to the carina) before endobronchial blocker placement. Before endotracheal intubation, the insertion depth was preset as the CT-measured length of the main bronchus minus 2 cm and was marked (marker 1) on the tracheal tube (Figure 3a). The endobronchial blocker was inserted through the tracheal tube until the point A of the sacculus reached the catheter tip. The positions on the blocker which paralleled the screw cap (marker 2) and the screw cap plus 2 cm (marker 3) were marked, then the endobronchial blocker was extubated after the cap was screwed up (Figure 3b). The tracheal tube was inserted to marker 1 under direct-vision laryngoscopy. The endobronchial blocker was inserted through the tracheal tube again. The connectors of the endobronchial blocker and the tracheal tube were fixed when the screw cap paralleled marker 2. The endobronchial blocker was further inserted until the screw cap paralleled marker 3 with resistance disappeared, and the sacculus was inflated with 1.5-2.5 ml of air (Figure 3c). Both lungs were auscultated to make sure that respiratory sounds disappeared in the lung of the blocking side. If proper blocking was not achieved after 5 consecutive repositionings, bronchoscopy-guided placement would be applied, and the patient would be excluded. The proper blocker placement was confirmed by auscultation after the patients shifted from the horizontal position to the lateral position.

Observational parameters: (1) the required time for successful blocker placement (measured since the endobronchial blocker was inserted through the vocal cord until it was placed at the proper position); (2) the number of repositionings for successful blocker placement (each extubation of the endobronchial blocker from the Tracheal tube was counted as one repositioning); (3) the successful rate of the first blocker positioning; (4) the degree of lung collapse ranked by the surgeon as excellent (complete lung collapse at the blocking side), fair (lung collapse at the blocking side with a little amount of residual air that would not affect surgical exposure), moderate (partial lung collapse which requires suction or manual collapse), and poor (no collapse of the lung) ¹³; (5) airway mucosal injury graded using bronchoscopy after surgery by an anesthetist as none (no mucosal edema), mild (mild mucosal edema), moderate (obvious mucosal edema and hyperemia), severe (mucosal erosion and hemorrhage) ¹¹; (6) pulmonary infection occurred within 72 h after surgery, which was defined as plaque-like shadow on both lungs with or without pleural effusion observed by chest X-ray; (7) trachyphonia after tracheal extubation; (8) the duration of postoperative mechanical ventilation; (9) the duration of postoperative intensive care unit (ICU) stay; (10) the duration of postoperative hospitalization.

Estimation of sample size: The sample size was estimated with α = 0.05 and 1-β = 0.8 using the PASS 15.0 software (NCSS, Utah, USA). According to our previous clinical experience, the adequacy of lung collapse was similar in the two groups. According to the estimation, at least 61 patients in each group needed to be enrolled to find a moderate variation (i.e., W = 0.3) between the two groups.

Statistical analyses: The SPSS 15.0 software (NCSS, Utah, USA) was used for statistical analyses. Continuous data with normal distribution are expressed as mean ± standard deviation and were analyzed using the independent-sample t test; continuous data with abnormal distribution are expressed as median (interquartile range) and were analyzed using the Wilcoxon rank-sum test; categorical data are expressed as cases (%) and were analyzed using the Pearson χ² test or the χ² test with correction for continuity. P < 0.05 was considered significant.

A total of 127 pediatric patients were assessed for eligibility. Five patients were excluded due to the abnormal takeoff of the right upper lung lobe; 3 patients withdrew from the study after grouping because one‐lung ventilation technique was deemed not necessary by the surgeon. Therefore, 119 patients were enrolled into this study (Figure 4). The two groups had no significant differences in demographic characteristics, including age, sex, weight, height, ASA stage, and thoracic surgery type (P > 0.05; Table 1).

The required time for successful blocker placement was significantly longer in the CT group than in the BRO group (124.9 ± 34.2 s vs. 92.9 ± 17.6 s, P < 0.001), successful blocker placement required more repositionings in the CT group than in the BRO group (1.22 ± 0.56 vs. 1.05 ± 0.28, P < 0.05), and the successful rate of the first blocker positioning was significantly lower in the CT group than in the BRO group (82.8% vs. 96.7%, P < 0.05) (Table 2). After blocking, the degree of lung collapse was excellent in 56 patients and fair in 2 patients from the CT group and was excellent in all the 61 patients from the BRO group, without significant difference (P > 0.05). After surgery, mild airway mucosal injury was observed in 2 patients from the CT group and 1 from the BRO group (P > 0.05). For both groups, 2 patients had pulmonary infection within 72 h after surgery, and 3 had trachyphonia after tracheal extubation (both P > 0.05). No significant differences in the durations of postoperative mechanical ventilation, ICU stay, and hospitalization were observed between the two groups (all P > 0.05).

The insertion of the finest 5F endobronchial blocker requires a Tracheal tube with an internal diameter greater than 4.5 mm¹⁴. While applying OLV in pediatric patients, bronchoscopy cannot be used to guide intraluminal blocker placement if the insertion of a Tracheal tube with an internal diameter greater than 4.5 mm is not applicable. In the present study, we used chest CT 3-dimentional reconstruction to measure the airway and guide endobronchial blocker placement.

While comparing the techniques used for lung isolation, safety and efficiency should be considered. The adequacy of lung collapse affects surgical exposure and is a criterion for the assessment of successful OLV ¹⁵. In the present study, CT-guided endobronchial blocker placement achieved similar adequacy of lung collapse as compared with bronchoscopy-guided blocker placement in pediatric patients. The sacculuses of most endobronchial blockers are featured by small volume and high pressure, and excessive inflation may induce pressure mucosal injury; during sacculus inflation procedures, the advantage of direct vision under bronchoscopy was considered to be important for the prevention of sacculus inflation-caused mucosal injury in small bronchi ¹⁶. However, in the present study, no significant difference in airway mucosal injury was observed between the BRO and CT groups, suggesting that CT-guided endobronchial blocker placement would not increase the risk of airway mucosal injury. In addition, the rates of postoperative pulmonary infection and trachyphonia were similar in the two groups (P > 0.05). Regarding postoperative pulmonary recovery, no significant differences in the durations of mechanical ventilation, ICU stay, and hospitalization were observed between the two groups. Therefore, we consider that using CT 3-dimentional airway reconstruction to guide endobronchial blocker placement is feasible and safe.

We postulated that CT 3-dimentional reconstruction may be used to accurately estimate the insertion depth of Tracheal tube before blocking. The distance from point A to point B on the tip of endobronchial blocker is approximately 2 cm. Inserting the uncuffed Tracheal tube without side holes to 2 cm above the carina would leave enough space to allow the insertion of endobronchial blocker for laterobronchus blocking ¹⁷. In addition, by checking the markers on the endobronchial blocker during insertion, we could determine the optimal insertion depth in the bronchus of the blocking side. Therefore, CT 3-dimentional reconstruction-guided endobronchial blocker placement can be used for quick intraluminal blocking.

Narayanaswamy et al. ¹⁸ reported that the median time to complete the placement procedures under the guidance of fiberoptic bronchoscopy was 203 seconds, whereas Campos et al. ¹³ reported a duration of 158 seconds. Peng et al. ¹⁹ reported that the placement time was 185 seconds. In the present study, it was 92.9 s in the BRO group and 124.9 s in the CT group, both were much shorter than those reported in literature. It may be explained by that endobronchial blocking was performed by anesthetists with 6-year experience of thoracic anesthesia in our center, who were skilled in performing both endobronchial blocking and bronchoscopy²⁰. In the present study, the required time was longer in the CT group than in the BRO group because CT-guided blocker placement required the assistance of auscultation, costing longer time than placing the blocker under direct vision through bronchoscopy.

The present study contained some limitations. First, the major limitation was that the adequacy of lung collapse relied on surgeons’ subjective assessment. Second, this was a single-center study, and the feasibility of using CT 3-dimentional airway reconstruction to guide endobronchial blocker placement needs to be validated in future multi-center studies. Third, pediatric patients with abnormal takeoff of the right upper lung lobe were excluded. The application of CT-guided endobronchial blocker placement in these patients needs further investigation.

In conclusion, comparing with bronchoscopy-guided endobronchial blocker placement, CT-guided blocker placement achieved similar adequacy of lung collapse. Although CT guidance may increase the required time and repositionings for successful blocker placement, it will not increase bronchus mucosal injury and affect postoperative pulmonary recovery. Therefore, for pediatric patients who need to undergo surgery with OLV, CT 3-dimentional airway reconstruction is a simple and efficient technique for endobronchial blocker placement.

computed tomography (CT)

one-lung ventilation (OLV)

intensive care unit (ICU)

bronchoscopy (BRO)

Ethics approval and consent to participate: This study was approved by the Research Ethics Committee of Guangzhou Women and Children’s Medical Center. Since the study was retrospective, the Research Ethics Committee of Guangzhou Women and Children’s Medical Center agreed to waive patient parental consent to review their medical records. Images relating to participants in the manuscript were obtained with written informed consent from the guardian. The study protocol was complied with the 1975 Declaration of Helsinki.

Consent for publication: Not applicable.

Availability of data and material: All data are available from the corresponding author by request.

Competing interests: The authors declare that they have no competing interests

Funding: No specific funding from private and public sectors for this study.

Acknowledgements: Not Applicable

Authors' contributions:

(I) Conception and design: YX, WL;

(II) Administrative support: WL, YT;

(III) Provision of study materials or patients: YX, NZ, WW, WL;

(IV) Collection and assembly of data: YX, YT;

(V) Data analysis and interpretation: MZ, JH;

(VI) Manuscript writing: All authors;

(VII) Final approval of manuscript: All authors.

These authors contributed equally to this work.

Authors' Information：Yingyi Xu, M.M., Na Zhang, M.M., Wei, Wei, M.M., Yonghong Tan, M.D., Minting Zeng, M.M., Jianning Hou, M.M., Wei Liu, M.M.

Corresponding author: Wei Liu

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Table 1. Demographic characteristics, analgesia, and surgery type in the two groups of patients.

Variable	The CT group	The BRO group	P-value
Variable	(n=58)	(n=61)	P-value
Sex [cases (%)]			0.862
Male	41 (70.7%)	44 (72.1%)
Female	17 (29.3%)	17 (27.9%)
Age (months)	17.8 ± 8.6	17.3 ± 9.6	0.820
Weight (kg)	9.91 ± 2.14	9.74 ± 2.98	0.732
Height (cm)	75.9 ± 19.3	76.78 ± 14.12	0.773
ASA stage [cases (%)]			0.994
ASA I	32 (55.2%)	34 (55.7%)
ASA II	22 (37.9%)	26 (42.6%)
ASA III	4 (6.9%)	1 (1.6%)	0.347
Blocking side [cases (%)] Left Right	34 (58.6%) 24 (41.4%)	30 (49.2%) 31 (50.8%)	0.302
Type of surgery [cases (%)] Mediastinal mass surgery Lung surgery Diaphragm surgery Esophageal surgery	17 (29.3%) 26 (44.8%) 6 (10.3%) 9 (15.5%)	12 (19.7%) 27 (44.3%) 9 (14.8%) 13 (21.3%)	0.541

Table 2. Comparison of endobronchial blocker placement and postoperative recovery bet ween the two groups

Variable	The CT group	The BRO group	P-value
Variable	(n=58)	(n=61)	P-value
Required time for successful blocker placement (s)	124.9 ± 34.2	92.9 ± 17.6	0.001
Number of repositionings for successful blocker placement	1.22 ± 0.56	1.05 ± 0.28	0.037
The success of the first blocker positioning [cases (%)] Yes No	48 (82.8%) 10 (17.2%)	59 (96.7%) 2 (3.3%)	0.011
Degree of lung collapse [cases (%)] Excellent Fair Moderate Poor Grade of airway mucosal injury [cases (%)] None Mild Moderate Severe	56 (96.6%) 2 (3.4%) 0 (0%) 0 (0%) 56 (3.4%) 2 (3.4%) 0 (0%) 0 (0%)	61 (100%) 0 (0%) 0 (0%) 0 (0%) 60 (98.3%) 1 (1.7%) 0 (0%) 0 (0%)	0.235 0.965
Pulmonary infection within 72 h after surgery [cases (%)] Yes No	2 (3.4%) 56 (96.6%)	2 (3.3%) 59 (96.7%)	1.000
Trachyphonia after tracheal extubation [cases (%)] Yes No	3 (5.2%) 55 (94.8%)	3 (4.9%) 58 (95.1%)	1.000
Duration of postoperative mechanical ventilation (h)	34.3 ± 95.6	29.1 ± 62.7	0.726
Duration of postoperative ICU stay (days)	2.9 ± 6.3	2.5 ± 3.2	0.658
Duration of postoperative hospitalization (days)	13.6 ± 11.2	13.3 ± 7.6	0.882

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CT 3-Dimentional Airway Reconstruction-guided Intraluminal Placement of Endobronchial Blocker in Pediatric Patients: A Randomized Controlled Study

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