Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183515
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2023-11-30
Brief Title:
Continuous Positive Airway Pressure CPAP Pediatric Patients With Subglottic Stenosis Who Undergo Balloon Dilatation
Sponsor:
Umraniye Education and Research Hospital
Organization:
Umraniye Education and Research Hospital
Study Overview
Official Title:
The Effect of Continuous Positive Airway Pressure CPAP Application on Airway Problems in Pediatric Patients With Subglottic Stenosis Who Undergo Balloon Dilatation
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 stenosisThe 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 83 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 406 of children who underwent balloon dilation experienced desaturation Additionally tracheotomy was required in 156 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
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 406 of children who underwent balloon dilation experienced desaturation Additionally tracheotomy was required in 156 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None