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

NCT ID: NCT06183515

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-06-30

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.

Conditions

Airway Complication of Anesthesia; Congenital Subglottic Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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

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

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 144 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zeliha Alicikus

Head of Anesthesiology and Reanimation department,Assoc Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zeliha ZT tuncel

Role: STUDY_DIRECTOR

Umraniye ERH

Locations

Umraniye Education and Research Hospital

Istanbul, Umraniye, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 39844310 (View on PubMed)

Other Identifiers

UERH-AR-ZT-01

Identifier Type: -

Identifier Source: org_study_id