Formation implementation team
A team of 10 members was formed to implement the nasal irrigation care program by the director of nursing, the chief nurse, the ENT physician, the responsible ENT nurse, and the graduate nursing student. One director of the nursing department and one chief nurse were responsible for team management, process development, quality control and coordination. 2 otolaryngologists were responsible for patient treatment and monitoring physiological indicators. 4 nurses were responsible for program implementation and monitoring records and 2 graduate nursing students were responsible for education and training as well as data collection. All members of the team have been systematically trained in the physiopathology of chronic sinusitis, functional nasal endoscopic sinus surgery, nasal irrigation and other specialized theoretical knowledge and clinical skills.
Study design and sample size calculation
The study is a parallel, single-blind, randomized controlled trial. Calculate the sample size by comparing two sets of Lund-Mackay CT Scores. According to the sample size calculation formula n1 = n2 = (Zα+ Zβ)2×2σ2 / δ2, hypothesis α = 0.05, Zα=1.96; β = 0.2, Zβ=0.84; further reference to the literature σ = 2.30, δ = 1.76[7]. Considering the shedding rate of 20%, the number of sample cases in each group is 33 through bilateral inspection, and the total sample size is 66.
Target of study
The participants were recruited from the department of ENT of the First Hospital of Shanxi Medical University, from February 2023 to May 2023. 66 CRS patients were included in our study and randomly divided into an intervention group and a control group according to a random number table, with 33 cases each.
Inclusion criteria
Meeting the diagnostic criteria of chronic rhinosinusitis; 18–75 years old, regardless of gender; Voluntarily accepting comprehensive treatment such as nasal endoscopic surgery, postoperative nasal irrigation and regular postoperative review; Voluntarily signing the informed consent and submitting to the requirements of this study.
Exclusion criteria
Patients with other nasal sinus diseases such as benign nasal and sinus tumors, cases with abnormal nasal structures, allergic rhinitis, mycosis fungoides, odontogenic maxillary sinus infections, etc.; Patients during pregnancy or lactation; Patients in critical condition or combined with serious diseases of other systems such as heart, liver and kidney; Patients who could not cooperate with the treatment and could not understand the questionnaire correctly.
Methods
The program included 22 entries in 7 areas. Nasal rinse preparation, nasal rinse implementation process, adverse reaction prevention, rinse disposal, review, health education and follow-up(Table 1). To better achieve the purpose, the study team developed relevant nursing instruments according to the nasal rinse care program, such as nasal rinse care record sheets, education materials, and training for study members. After systematic education and training, the program was implemented by the implementation team at the ENT of a hospital in Taiyuan, Shanxi Province. The visual analog scale (VAS)[8], Sino-Nasal Outcome Test − 20(SNOT-20)[9, 10], endoscopic Lund–Kennedy score (LKES)[1] results, Lund-Mackay CT[1] results and Overall efficacy[1] were recorded for all patients. Members of the study team instructed all patients included in the study to fill out the general information form, VAS scale and SNOT-20 scale before surgery, and the physicians in team used LKES to assess the severity of the patients' disease. All patients underwent nasal endoscopy by the same senior physician, and nasal irrigation was started at 24-48h postoperatively when filling material was extracted and there was no active bleeding or discomfort. The control group was given the usual care and the experimental group was given care according to the evidence-based care program for nasal irrigation. All patients were asked to fill in the VAS scale, SNOT-20 scale at weeks 2, 4, and 12 of postoperative nasal irrigation, and the LKES was assessed by the group's attending physician again. A Overall outcome assessment of the patient was performed at week 12. All procedures performed in the current study were approved by the research ethics committee of our institution.
Table 1
Contents of entries in the nasal rinse evidence-based care protocol
Sports event | Content |
Pre-flush preparation | 1. Assessment: assess the patient's nasal condition before each rinse, and strictly prohibit rinsing in patients with acute inflammation of the upper respiratory tract and acute infection of the middle ear to prevent the spread of inflammation |
2. Psychological care: before rinsing, the nurse should introduce the purpose, method and precautions of nasal rinsing to the patient and family members, and mobilize the patient to actively cooperate with the treatment; For patients of different ages and with different psychological problems, the nurse should do a good job of psychological guidance; when the patient performs nasal rinsing for the first time, the nurse should be on the side to guide the patient to master the correct rinsing method through on-site demonstration and explanation. Patients can also observe and learn from other patients who have mastered the correct rinsing method. |
Flushing Implementation Process | 3. Flushing fluid: saline is recommended |
4. Flushing method: high volume low positive pressure flushing is recommended for adults; spray or nebulization is recommended for children |
5. Start rinsing time: 24–48 hours after removal of nasal stuffing, when there is no active bleeding and discomfort, start nasal rinsing |
6. Rinse position: lean forward, head down |
7. Rinse solution temperature: 35–38℃, not to exceed the basal body temperature to avoid damage to the nasal mucosa |
8. Dosage: large volume (> 200 mL) nasal saline rinses are recommended as an adjunct to other medications, depending on the condition of the patient's nasal mucosa |
9. Order: flush the side with severe nasal congestion first, then the other side to prevent the flushing fluid from flowing into the middle ear due to the resistance of the more severely blocked nasal cavity |
10. Flushing time: 5–10 minutes is the most appropriate, adjust the flushing speed according to the patient's comfort, and prevent irritation caused by too fast a flow rate and too high a water pressure |
11. Frequency: sequential flushing i.e. 2 times/day in weeks 1–2, 1 time/day in weeks 3–10 and 3 times/week after week10 |
12. Duration of rinsing: The nasal mucosa after nasal endoscopic surgery has to go through 3 stages, i.e. 1–2 weeks postoperative cavity cleaning stage, 3–10 weeks postoperative mucosal transformation stage, and 10 weeks postoperative epithelialization completion stage, so 10 weeks of continuous nasal rinsing after nasal endoscopic surgery may be the best time period, the specific duration depends on the condition Adherence |
13. Condition observation: when the patient is undergoing nasal rinsing the nurse should observe whether the patient's rinsing method is accurate, teach the patient to master the correct nasal rinsing method; and observe whether there is blood, scabs and purulent secretions in the rinsing fluid to observe the effectiveness and effect of rinsing |
Adverse reaction prevention | 14. Open mouth breathing is required during the rinsing process, don't inhale through the nose, and do not swallow or blow the nose to avoid choking and coughing; if coughing, sneezing or vomiting and ear pain occur during the rinsing process, stop immediately |
15. Prevention of nasal irritation: Don't apply too much pressure during rinsing to avoid excessive pressure, which may cause middle ear infection by flowing into the eustachian tube or choking and coughing by entering the trachea, and adjust slowly according to the patient's comfort level |
16. Prevention of nasal bleeding: educate before rinsing, instruct patients not to pick their nose and blow it hard, and control complication and their blood pressure in elderly patients with comorbidities |
17. After rinsing, instruct the patient to tilt the head forward so that the residual fluid in the nasal cavity is discharged, and then blow the nose gently on one side and one side respectively; do not blow the nose too sharply or violently or pinch both nostrils at the same time |
Flusher treatment | 18. To prevent secondary infection caused by corrosion or bacterial residue of the rinse device, instruct the patient to rinse and disinfect the rinse device after the nasal rinse is completed, and microwave disinfection is recommended |
19. To prevent the growth of bacteria and fungi, the douche should be replaced in 2–3 weeks |
Reexamination Health education | 20. review weekly in month 1, every 2 weeks in month 2, and monthly from month 3–6 until nasal mucosal epithelialization |
21. Before discharge, patients were taught the correct use of nasal irrigator; instructed to actively strengthen physical exercise, eat more fresh fruits and vegetables, and prevent colds; instructed not to dig their noses with fingers and blow their noses hard for 3 months; to keep the nasal mucosa moist at all times; and to avoid contact with allergens, and the above contents were compiled into a health education manual for health promotion and pushed to patients through the WeChat platform |
follow up visits | 22. Improve the follow-up system, establish a complete patient information file, do a good job of educating patients about self-care after discharge, issue a follow-up plan sheet, and record in detail each review of the patient |
Visual Analogue Scale (VAS)
Patients score their feelings on a simulated scale of 0 to 10 according to how they feel. 0 is no discomfort; 1 to 3 is mild discomfort that is tolerable; 4 to 6 is significant discomfort that is also tolerable and may interfere with sleep; and 7 to 10 is severe discomfort that should be avoided at all costs. Among them, a score of 4 or more is considered that the patient is in an uncomfortable state. The method is easy to use and more commonly applied, but it can only roughly assess the comfort level of patients and has not been scientifically and effectively validated.
Sino-Nasal Outcome Test-20 (SNOT-20)
This questionnaire consists of 20 entries and 3 classification levels, covering 3 areas including physical problems, sleep function, and psychological problems. Respondents were asked to rate the 20 symptoms according to their own sinusitis symptoms, with a score of 0 representing no distress to the respondent; 1 representing mild distress to the respondent; 2 representing moderate distress to the respondent; and 3 representing severe distress to the respondent. Finally, patients were asked to choose the 5 most important symptoms for themselves from the 20 symptoms. the higher the total score of the 20 symptoms, the worse the quality of life of the respondents.
Endoscopic Lund–Kennedy Score (LKES)
Polyps, edema, nasal leaks, scarring and crusting were scored according to the patient's mucosal morphology on endoscopic video, and each item was scored according to its condition and assessed separately on the left and right. Polyps: 0 for no polyps, 1 for polyps in the middle nasal tract only, 2 for polyps beyond the middle nasal tract; nasal leaks: 0 for no nasal leaks, 1 for clear thin nasal leaks, 2 for mucopurulent nasal leaks; edema, scarring, and crusting: 0 for none, 1 for mild, 2 for severe; 0 to 10 points per side, 0 to 20 points total.
Lund-Mackay CT Score
The Lund-Mackay CT score of the sinuses including the presence or absence of turbidity in the maxillary sinus, anterior group septal sinus, posterior group septal sinus, pterygoid sinus, and frontal sinus and presence or absence of obstruction in the sinonasal tract complex, assessed separately on the left and right. A score of 0 indicates no abnormality in the sinuses, 1 indicates partial turbidity, and 2 indicates total turbidity; sinonasal tract complex: 0 indicates no obstruction and 2 indicates obstruction; 0 to 12 points per side, total score 0 to 24.
Overall efficacy
Complete control of disease: complete disappearance of symptoms, VAS score 0, Lund-Kennedy score < 1, no edema of the mucosa of the nasal sinuses, no mucous or mucopurulent discharge, good opening of the sinus orifice, good epithelialization.
Partial control: obvious improvement of symptoms but not complete disappearance (total score of unilateral postoperative cavity assessment less than 3 is considered as an obvious improvement), VAS score is less than before at least 3 points reduction, LKES > 1, congestion and edema of mucosa in some areas of nasal sinuses, a small amount of mucous or mucopurulent discharge, mucosal hypertrophy or granulation.
Not controlled: no significant improvement in symptoms or no improvement at all. There was no significant reduction in VAS score and LKES compared with before treatment. Congestion and swelling of the mucosa of the nasal sinuses, accumulation of mucous or mucopurulent secretions, hyperplasia of connective tissue or even polyp formation, extensive adhesions of the mucosa of the operative cavity, and narrowing or atresia of the sinus opening.
Treatment efficiency = (n1 + n2)/N. n1: number of patients with complete control, n2:number of patients with partial control, N: number of all patients.
Statistical analysis
The statistical analysis was processed by with SPSS Statistics version 26.0. Demographic and clinical data are expressed as the means, SDs and frequency. The t-test, χ2 test, ANOVA were adopted to compare groups. P < 0.05 was defined statistically significant.