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

The Effect of Continuous Positive Airway Pressure (CPAP) Application on Airway Problems in Pediatric Patients With Subglottic Stenosis Who Undergo Balloon Dilatation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06183515
Enrollment
81
Registered
2023-12-27
Start date
2022-01-01
Completion date
2023-06-30
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Complication of Anesthesia, Congenital Subglottic Stenosis

Keywords

pediatric airway, subglottic stenosis, apne, CPAP

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.

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.

Sponsors

Umraniye Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
No minimum to 144 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Follow-up of recovery time in patients with CPAP compared to those without CPAPminutesrecovery unit time and aldrete score

Secondary

MeasureTime frameDescription
bronchospasm, the number of desaturation events, intubation, tracheostomy, recovery time, and the need for intensive carehoursspo2 below %94 is desaturation

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026