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CompletedNCT06183515Updated Nov 19, 2025

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

An interventional study of 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 in Airway Complication of Anesthesia and Congenital Subglottic Stenosis, sponsored by Umraniye Education and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged Up to 144 Months. Per ClinicalTrials.gov, last updated 2025-11-19.

Sponsored by Umraniye Education and Research Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
Up to 144 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Airway Complication of Anesthesia
  • Congenital Subglottic Stenosis

Keywords

  • pediatric airway
  • subglottic stenosis
  • apne
  • CPAP
03

Who can participate

Ages eligible
Up to 144 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA 2-3
  • acquired or congenital subglottic stenosis

Exclusion criteria

Exclusion Criteria:

  • congenital or acquired diseases of the primary lung or choanal atresia
  • younger than 38 gestational weeks
  • intubated patients
  • congenital cardiac defects
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
81 participants (actual)

Study arms

  • Placebo comparator
    non-CPAP (Control)

    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

  • Active comparator
    CPAP group

    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

  • ProcedureCPAP 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

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

05

What researchers measure

Primary outcomes

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

    recovery unit time and aldrete score

    Time frame: minutes

Secondary outcomes

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

    spo2 below %94 is desaturation

    Time frame: hours

06

Study locations

1 site
  • Umraniye Education and Research Hospital
    Istanbul, Umraniye 34734, Turkey (Türkiye)
07

References and documents

Publications

  • 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. PubMed 39844310 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06183515
Lead sponsor
Umraniye Education and Research Hospital
Responsible party
Zeliha Alicikus (Head of Anesthesiology and Reanimation department,Assoc Prof, Umraniye Education and Research Hospital) — Principal investigator
First posted
Dec 27, 2023
Start date
Jan 1, 2022
Primary completion
Oct 30, 2022
Completion
Jun 30, 2023
Last update
Nov 19, 2025

Study contacts

zeliha ZT tuncel
study director · Umraniye ERH

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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