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

NCT06183515 | Completed DMC

• 1 other identifier: UERH-AR-ZT-01
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Complication of Anesthesia; Congenital Subglottic Stenosis

Keywords

pediatric airway; subglottic stenosis; apne; CPAP

Outcome Measures

Primary Outcomes (1)

• Follow-up of recovery time in patients with CPAP compared to those without CPAP

  recovery unit time and aldrete score

  minutes

Secondary Outcomes (1)

• bronchospasm, the number of desaturation events, intubation, tracheostomy, recovery time, and the need for intensive care

  hours

Study Arms (2)

non-CPAP (Control)

PLACEBO COMPARATOR

The non-CPAP group received Fi02:0.6, and oxygen support was provided at a rate of 3 liters per minute (L/min) either via mask for those who were extubated or through a T-piece for those with a tracheostomy cannula.

Procedure: CPAP group: postoperative CPAP support, non-CPAP group: oxygen 3 liters per minute (L/min) either via mask for those who were extubated or through a T-piece for those with a trash

CPAP group

ACTIVE COMPARATOR

During the postoperative period, the CPAP group received Fi02:0.6 and 8 to 12 mmHg of nasal CPAP, or CPAP was initiated through the tracheostomy cannula.

Procedure: CPAP group: postoperative CPAP support, non-CPAP group: oxygen 3 liters per minute (L/min) either via mask for those who were extubated or through a T-piece for those with a trash

Interventions

CPAP group: postoperative CPAP support, non-CPAP group: oxygen 3 liters per minute (L/min) either via mask for those who were extubated or through a T-piece for those with a trash PROCEDURE

The effect of CPAP was prevent atelectasis after apnoeic ventilation during the procedure and to reduce post-procedural airway problems.

CPAP group; non-CPAP (Control)

Eligibility Criteria

• Age: Up to 144 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA 2-3
• acquired or congenital subglottic stenosis

You may not qualify if:

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

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, Umraniye, 34734, Turkey (Türkiye)

Location

Related Publications (1)

• Tuncel Z, Goksu S, Deligoz O, Saracoglu KT, Albasha A, Abdallah BM, Saracoglu A. The effect of continuous positive airway pressure (CPAP) application on airway problems in pediatric patients with subglottic stenosis who undergo balloon dilatation. Perioper Med (Lond). 2025 Jan 23;14(1):10. doi: 10.1186/s13741-024-00478-5.

  PMID: 39844310 DERIVED

MeSH Terms

Conditions

Laryngostenosis

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• zeliha ZT tuncel

  Umraniye ERH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology and Reanimation department,Assoc Prof

Model Details: The study included a total of 81 pediatric patients who were 0 to 12 years of age, classified as II and III according to the American Society of Anesthesiologists (ASA), and who underwent elective subglottic balloon dilation under general anesthesia due to acquired or congenital subglottic stenosis.Patients were randomized into two groups through computer-generated randomization into two groups: Group non-CPAP (Control, n=41) and Group CPAP (n=40).During the postoperative period, the CPAP group received Fi02:0.6 and 8 to 12 mmHg of nasal CPAP, or CPAP was initiated through the tracheostomy cannula. The non-CPAP group received Fi02:0.6, and oxygen support was provided at a rate of 3 liters per minute (L/min) either via mask for those who were extubated or through a T-piece for those with a tracheostomy cannula.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 27, 2023
• Study Start: January 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: June 30, 2023
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)