Pediatric tracheostomy decannulation protocol: evidence of content validation

This methodological study was conducted in four stages: (1) submission of the project to the research ethics committee, (2) systematic review of the literature, (3) preparation of the clinical protocol, and (4) evaluation of the quality of information with specialists. The preparation phase followed the recommendations of the Guide for the Construction of Assistance Protocols. The quality of the protocol was evaluated by eight pediatric specialists using the Appraisal of Guidelines Research and Evaluation (AGREE II). An acceptable suitability of the protocol was considered when there was a 78% or greater agreement among the specialists.

Results

Based on this systematic review, five recommendations were listed to compose the protocol for decannulating tracheostomy in children represented in a flowchart. The suitability of the protocol varied between 81.94 and 95.83%, with an overall assessment rate of 93.75%. All specialists recommended an appropriate protocol for use in healthcare services.

Conclusion

The decannulation protocol for chronic children is valid and adequate. Future research with randomized designs is recommended for this population to assess the impact of the use of the protocol and its cost-effectiveness for health services.

Keywords:
Tracheostomy; Clinical protocols; Patient safety; Child; Biomedical technology

Recommendations	References	Scientific evidence
1. Perform endoscopic assessment of airway anatomy and functionality to confirm adequate patency at all levels and exclude or treat complications.	Avelino et al.(²2 Avelino MAG, Maunsell R, Valera FCP, Lubianca Neto JF, Schweiger C, Miura CS, et al. First Clinical Consensus and National Recommendations on Tracheostomized Children of the Brazilian Academy of Pediatric Otorhinolaryngology (ABOPe) and Brazilian Society of Pediatrics (SBP). Rev Bras Otorrinolaringol (Engl Ed). 2017;83(5):498-506. PMid:28807655.), 2017;	Level of Evidence: 2b, 4 and 5
	Benjamin e Curley(²³23 Benjamin B, Curley JWA. Infant tracheotomy - endoscopy and decannulation. Int J Pediatr Otorhinolaryngol. 1990;20(2):113-21. http://dx.doi.org/10.1016/0165-5876(90)90076-4. PMid:2286504. http://dx.doi.org/10.1016/0165-5876(90)9... ), 1990; Canning et al. (⁷7 Canning J, Mills N, Mahadevan M. Pediatric tracheostomy decannulation: when can decannulation be performed safely outside of the intensive care setting? A 10 year review from a single tertiary otolaryngology service. Int J Pediatr Otorhinolaryngol. 2020;133:109986. http://dx.doi.org/10.1016/j.ijporl.2020.109986. PMid:32199340. http://dx.doi.org/10.1016/j.ijporl.2020.... ), 2020;	Grade of recommendation: B, C, and D
	Kennedy et al. (²⁴24 Kennedy A, Hart CK, de Alarcon A, Balakrishnan K, Boudewyns A, Chun R, et al. International Journal of Pediatric Otorhinolaryngology International Pediatric Otolaryngology Group (IPOG) management recommendations : pediatric tracheostomy decannulation. Int J Pediatr Otorhinolaryngol. 2021;141:110565. http://dx.doi.org/10.1016/j.ijporl.2020.110565. PMid:33341719. http://dx.doi.org/10.1016/j.ijporl.2020.... ), 2021.	Risk of bias: low to moderate
2. Progressively promote occlusion/packaging of the tracheostomy tube if the airway is patent.	Avelino et al.(²2 Avelino MAG, Maunsell R, Valera FCP, Lubianca Neto JF, Schweiger C, Miura CS, et al. First Clinical Consensus and National Recommendations on Tracheostomized Children of the Brazilian Academy of Pediatric Otorhinolaryngology (ABOPe) and Brazilian Society of Pediatrics (SBP). Rev Bras Otorrinolaringol (Engl Ed). 2017;83(5):498-506. PMid:28807655.), 2017;	Level of Evidence: 2b, 4 and 5
	Kennedy et al. (²⁴24 Kennedy A, Hart CK, de Alarcon A, Balakrishnan K, Boudewyns A, Chun R, et al. International Journal of Pediatric Otorhinolaryngology International Pediatric Otolaryngology Group (IPOG) management recommendations : pediatric tracheostomy decannulation. Int J Pediatr Otorhinolaryngol. 2021;141:110565. http://dx.doi.org/10.1016/j.ijporl.2020.110565. PMid:33341719. http://dx.doi.org/10.1016/j.ijporl.2020.... ), 2021	Grade of recommendation: B, C, and D
	Maslan et al.(⁶6 Maslan JT, Feehs KR, Kirse DJ. Considerations for the successful decannulation of the pediatric patient: A single surgeon’s experience. Int J Pediatr Otorhinolaryngol. 2017;98:116-20. http://dx.doi.org/10.1016/j.ijporl.2017.04.038. PMid:28583487. http://dx.doi.org/10.1016/j.ijporl.2017.... ), 2017; Mitchell et al.(¹²12 Mitchell RB, Hussey HM, Setzen G, Jacobs IN, Nussenbaum B, Dawson C, et al. Clinical consensus statement: tracheostomy care. Otolaryngol Head Neck Surg. 2013;148(1):6-20. http://dx.doi.org/10.1177/0194599812460376. PMid:22990518. http://dx.doi.org/10.1177/01945998124603... ), 2013;	Risk of bias: low, moderate, and high
	Pozzi et al.(⁹9 Pozzi M, Galbiati S, Locatelli F, Clementi E, Strazzer S. Performance of a tracheostomy removal protocol for pediatric patients in rehabilitation after acquired brain injury: factors associated with timing and possibility of decannulation. Pediatr Pulmonol. 2017;52(11):1509-17. http://dx.doi.org/10.1002/ppul.23832. PMid:28950420. http://dx.doi.org/10.1002/ppul.23832... ), 2017.
3. Use pulse oximetry to monitor signs of respiratory distress and desaturation in hospital admissions during the decannulation process.	Canning et al.(⁷7 Canning J, Mills N, Mahadevan M. Pediatric tracheostomy decannulation: when can decannulation be performed safely outside of the intensive care setting? A 10 year review from a single tertiary otolaryngology service. Int J Pediatr Otorhinolaryngol. 2020;133:109986. http://dx.doi.org/10.1016/j.ijporl.2020.109986. PMid:32199340. http://dx.doi.org/10.1016/j.ijporl.2020.... ), 2020;	Level of Evidence: 2b and 4
	Pozzi et al.(⁹9 Pozzi M, Galbiati S, Locatelli F, Clementi E, Strazzer S. Performance of a tracheostomy removal protocol for pediatric patients in rehabilitation after acquired brain injury: factors associated with timing and possibility of decannulation. Pediatr Pulmonol. 2017;52(11):1509-17. http://dx.doi.org/10.1002/ppul.23832. PMid:28950420. http://dx.doi.org/10.1002/ppul.23832... ), 2017;	Grade of recommendation: B and C
	Seligman et al.(²¹21 Seligman KL, Liming BJ, Smith RJH. Pediatric tracheostomy decannulation: 11-year experience. Otolaryngol Head Neck Surg. 2019;161(3):499-506. http://dx.doi.org/10.1177/0194599819842164. PMid:30987524. http://dx.doi.org/10.1177/01945998198421... ), 2019.	Risk of bias: low to moderate

4. Consider polysomnography to assess airway functionality during sleep, depending on the clinical and structural complexity of the patient.	Kennedy et al.(²⁴24 Kennedy A, Hart CK, de Alarcon A, Balakrishnan K, Boudewyns A, Chun R, et al. International Journal of Pediatric Otorhinolaryngology International Pediatric Otolaryngology Group (IPOG) management recommendations : pediatric tracheostomy decannulation. Int J Pediatr Otorhinolaryngol. 2021;141:110565. http://dx.doi.org/10.1016/j.ijporl.2020.110565. PMid:33341719. http://dx.doi.org/10.1016/j.ijporl.2020.... ), 2021;	Level of Evidence: 2b and 5
	Lee et al.(¹³13 Lee J, Soma MA, Teng AY, Thambipillay G, Waters KA, Cheng AT. The role of polysomnography in tracheostomy decannulation of the paediatric patient. Int J Pediatr Otorhinolaryngol. 2016;83(4):132-6. http://dx.doi.org/10.1016/j.ijporl.2016.01.034. PMid:26968066. http://dx.doi.org/10.1016/j.ijporl.2016.... ), 2016.	Grade of recommendation: B and D
		Risk of bias: low to moderate

5. Keep the child under hospital observation for 24 hours after decannulation.	Kennedy et al.(²⁴24 Kennedy A, Hart CK, de Alarcon A, Balakrishnan K, Boudewyns A, Chun R, et al. International Journal of Pediatric Otorhinolaryngology International Pediatric Otolaryngology Group (IPOG) management recommendations : pediatric tracheostomy decannulation. Int J Pediatr Otorhinolaryngol. 2021;141:110565. http://dx.doi.org/10.1016/j.ijporl.2020.110565. PMid:33341719. http://dx.doi.org/10.1016/j.ijporl.2020.... ), 2021.	Level of Evidence: 2b
	Maslan et al.(⁶6 Maslan JT, Feehs KR, Kirse DJ. Considerations for the successful decannulation of the pediatric patient: A single surgeon’s experience. Int J Pediatr Otorhinolaryngol. 2017;98:116-20. http://dx.doi.org/10.1016/j.ijporl.2017.04.038. PMid:28583487. http://dx.doi.org/10.1016/j.ijporl.2017.... ), 2017;	Grade of recommendation: B
	Prickett and Sobol(²⁸28 Prickett KK, Sobol SE. Inpatient observation for elective decannulation of pediatric patients with tracheostomy. JAMA Otolaryngol Head Neck Surg. 2015;141(2):120-5. http://dx.doi.org/10.1001/jamaoto.2014.3013. PMid:25429439. http://dx.doi.org/10.1001/jamaoto.2014.3... ), 2015.	Risk of bias: low to moderate

Domain 1 - Scope and Purpose	J1	J2	J3	J4	J5	J6	J7	J8	Total
1. The overall objectives of the guideline are clearly described.	7	7	7	6	2	7	7	5	48
2. The health issues covered by the guideline are clearly described.	7	6	7	7	7	7	6	5	52
3. The population (patients, public, etc.) for whom the guideline is intended is clearly described.	7	7	7	7	7	7	7	7	56
Total	21	20	21	20	16	21	20	17	156
Suitability for Domain 1 - 91.66%
Domain 2 - Stakeholder Engagement	J1	J2	J3	J4	J5	J6	J7	J8	Total
4. The guideline development group includes individuals from all relevant professional groups.	7	7	7	7	2	7	7	2	46
5. The views and preferences of the target population (patients, public, etc.) have been sought.	7	7	7	1	1	7	7	3	40
6. The target users (patients, public, etc.) of the guideline are clearly defined.	7	7	7	7	7	7	7	7	56
Total	21	21	21	15	10	21	21	12	142
Suitability for Domain 2 - 81.94%
Domain 3 - Rigor of Development	J1	J2	J3	J4	J5	J6	J7	J8	Total
7. Systematic methods were used to search for evidence.	7	7	7	7	7	7	7	6	55
8. The criteria for selecting the evidence are clearly described.	7	7	7	7	7	7	7	5	54
9. The strengths and limitations of the body of evidence are clearly described.	7	7	7	7	7	7	7	5	54
10. The methods for formulating the recommendations are clearly described.	7	7	7	7	7	7	7	5	54
11. The health benefits, side effects, and health risks were considered in formulating the recommendations.	7	7	7	7	7	7	7	5	54
12. There is an explicit relationship between the recommendations and the supporting evidence.	7	7	7	7	7	7	7	6	55
13. The guideline was externally reviewed by experts prior to its publication.	7	7	7	3	7	7	7	7	52
14. A procedure for updating the guideline is provided.	7	7	7	7	6	7	7	6	54
Total	56	56	56	52	55	56	56	45	432
Suitability for Domain 3 - 95.83%
Domain 4 - Clarity of Presentation	J1	J2	J3	J4	J5	J6	J7	J8	Total
15. The recommendations are specific and unambiguous.	7	7	7	7	5	7	7	5	52
16. The different options for addressing the condition or health issue are clearly presented.	6	7	7	7	5	7	6	6	51
17. Key recommendations are easily identifiable.	7	7	7	7	7	7	7	6	55
Total	20	21	21	21	17	21	20	17	158
Suitability for Domain 4 - 93.05%
Domain 5 - Applicability	J1	J2	J3	J4	J5	J6	J7	J8	Total
18. The guideline describes the facilitating factors and barriers to its application.	6	7	7	3	6	7	7	6	49
19. The guideline provides advice and/or tools on how the recommendations can be put into practice.	7	6	7	7	6	7	7	7	54
20. The potential resource implications of applying the recommendations were considered.	6	7	7	4	7	7	6	6	50
21. The guideline presents monitoring and/or auditing criteria.	6	7	6	6	7	7	7	6	52
Total	25	27	27	20	26	28	27	25	205
Suitability for Domain 5 - 90.10%
Overall evaluation score: 93.75%
Technology use recommendation: yes

Academia Brasileira de Audiologia Rua Itapeva, 202, conjunto 61, CEP 01332-000, Tel.: (11) 3253-8711, Fax: (11) 3253-8473 - São Paulo - SP - Brazil
E-mail: revista@audiologiabrasil.org.br

Acompanhe os números deste periódico no seu leitor de RSS

[1] Conflict of interests: No.