Continuous Positive Airway Pressure (CPAP) Pediatric Patients With Subglottic Stenosis Who Undergo Balloon Dilatation

Not Applicable

Completed

• Conditions: Congenital Subglottic Stenosis; Airway Complication of Anesthesia

• Registration Number: NCT06183515
• Lead Sponsor: Umraniye Education and Research Hospital

Brief Summary

Nasal continuous positive airway pressure (CPAP) acts as a 'pressure' bridge between spontaneous breathing and controlled mechanical ventilation. As a result, there is an increasing trend in the prophylactic use of nasal CPAP in pediatric patients following high-risk airway procedures to reduce postoperative airway complications. Still, there is no study published on the prophylactic use of balloon dilatation in children with tracheal stenosis.The study hypothesizes that implementing postoperative prophylactic CPAP in pediatric cases with subglottic stenosis undergoing balloon dilation may shorten recovery time and minimize airway complications.

Detailed Description

Acquired pediatric subglottic stenosis is reported to have a prevalence of 1-2% . This rate reaches 8.3% in different case series. Acquired pediatric subglottic stenosis is commonly attributed to prolonged intubation, whereas the etiology also involves a history of traumatic or difficult airway. Balloon dilation laryngoplasty is an efficient and safe technique for treating primary and secondary acquired laryngotracheal stenosis. It is successfully applied in these children. Airway surgery typically necessitates a deeper level of anesthesia to control airway reflexes and manage the fluctuations in hemodynamic parameters, which are characteristic of this surgery.

Nevertheless, general anesthesia must be applied several times to patients due to the need for multiple balloon dilatations. At the same time, the procedure also necessitates coping with postoperative complications that may arise. Because alveolar collapse, which is related to general anesthesia, impairs gas exchange by creating a shunt effect, potentially increasing perioperative hypoxemic episodes, which in turn increases the risk for postoperative pulmonary complications. A recent retrospective analysis found that 40.6% of children who underwent balloon dilation experienced desaturation. Additionally, tracheotomy was required in 15.6% of cases, with an equal percentage needing tracheal intubation.

Prophylactic CPAP in pediatric cases has been shown to improve oxygenation by reducing the alveolar-arterial oxygen difference after pediatric laparoscopic surgery. However, it has been proven that CPAP applied after pediatric cardiac surgery has favorable effects on peak expiratory flow.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-10-30
• Study Completion: 2023-06-30
• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• ASA 2-3
• acquired or congenital subglottic stenosis

Exclusion Criteria

• congenital or acquired diseases of the primary lung or choanal atresia
• younger than 38 gestational weeks
• intubated patients
• congenital cardiac defects

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Follow-up of recovery time in patients with CPAP compared to those without CPAP	minutes	recovery unit time and aldrete score

Secondary Outcome Measures

Name	Time	Method
bronchospasm, the number of desaturation events, intubation, tracheostomy, recovery time, and the need for intensive care	hours	spo2 below %94 is desaturation

Trial Locations

Locations (1)

Umraniye Education and Research Hospital; 🇹🇷 Istanbul, Umraniye, Turkey