NCT05328206

Air Leak Test In Pediatric Intensive Care Unit

Air Leak Test in Pediatric Intensive Care Unit : a Multicentric and Prospective Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 900 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 2 Days – 17 Years
• Healthy volunteers: Not accepted

Summary

Respiratory distress by upper airway obstruction (UAO) is the primary etiology of extubation failure in children hospitalized in pediatric intensive care unit (PICU). This complication may require various invasive therapeutic which increase morbi-mortality and length of hospital stay. Cuff leak test (CLT) measured prior extubation to predict post-extubation UAO has been widely used in adult. The test compared expired tidal volume with cuff inflated and cuff deflated in order to predict UAO. Despite its frequent use in PICU, his predictive value to predict UAO in children is still poorly documented. Therefore, we conducted the first multicentric, prospective study to evaluate the CLT as a predictor of post-extubation UAO in critically ill children. The Primary objective is to assess the effectiveness of CLT in predicting severe respiratory distress by UAO within 48 hours of extubation in a critically ill children.

Conditions

• Respiratory Distress
• Upper Airway Obstruction

Interventions

Type	Name	Description
OTHER	Standard of care for intubated children	Patient ventilated through a cuffed endotracheal tube and having a cuff leak test prior extubation

Timeline

• Start date: 2022-10-05
• Primary completion: 2024-03-07
• Completion: 2024-04-03
• First posted: 2022-04-14
• Last updated: 2023-05-11

Locations

19 sites across 1 country: France