Air Leak Test In Pediatric Intensive Care Unit

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Distress, Upper Airway Obstruction

Intervention / Treatment
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* Other: Standard of care for intubated children


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 2 day to < 18 years of age, Ventilated through a cuffed endotracheal tube, Expected duration of mechanical ventilation ≥ 24 hours, Having a cuff leak test prior extubation, Placed on the assist control setting during CLT, No opposition from parents or patient Exclusion Criteria: Receiving mechanical ventilation via a tracheostomy, Unplanned extubation, Patient with long-term non-invasive ventilation (NIV), History of upper airways pathology, Surgery of upper airways less than 1 month old, Limitations of medical care in place, Parents or patient opposition, Already been included in this study, Not affiliated with social security.

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of care for intubated children with a cuffed endotracheal tube (c-ETT)<br> | Other: Standard of care for intubated children<br>* Patient ventilated through a cuffed endotracheal tube and having a cuff leak test prior extubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory distress by post-extubation upper airway obstruction (UAO) | The respiratory distress will be assessed using the Westley score. The Westley score evaluates the severity of respiratory function by assessing five factors: level of consciousness, cyanosis, stridor, air entry, and retractions. A specific point values are given for each factor, and the final score sum has a range from 0 to 17. The greater the respiratory distress the more imminent the respiratory distress. Respiratory distress will be defined by a Westley score greater than or equal to 4 with a minimum of 1 for the stridor item, at the initiation of at least one of the following treatments (IVC, LNHD, NIV (CPAP, BiPAP or any other mode with two pressure levels), MV(reintubation or tracheotomy)). | within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of return to mechanical ventilation (after re-intubation) |  | within 48 hours | 
| Risk factors of severe respiratory distress (RD) | The respiratory distress will be assessed using the Westley score. The Westley score evaluates the severity of respiratory function by assessing five factors: level of consciousness, cyanosis, stridor, air entry, and retractions. A specific point values are given for each factor, and the final score sum has a range from 0 to 17. The greater the respiratory distress the more imminent the respiratory distress. Respiratory distress will be defined by a Westley score greater than or equal to 4 with a minimum of 1 for the stridor item, at the initiation of at least one of the following treatments (IVC, LNHD, NIV (CPAP, BiPAP or any other mode with two pressure levels), MV(reintubation or tracheotomy)). | within 48 hours | 
| Proportion of patients with intravenous corticosteroid therapy (IVC) | Proportion of patients with intravenous corticosteroid therapy (IVC) in progress 12 hours prior to scheduled extubation, whether initiated for extubation or pre-extubation, | at inclusion | 
| Predictive score for severe respiratory distress (RD) | The respiratory distress will be assessed using the Westley score. The Westley score evaluates the severity of respiratory function by assessing five factors: level of consciousness, cyanosis, stridor, air entry, and retractions. A specific point values are given for each factor, and the final score sum has a range from 0 to 17. The greater the respiratory distress the more imminent the respiratory distress. Respiratory distress will be defined by a Westley score greater than or equal to 4 with a minimum of 1 for the stridor item, at the initiation of at least one of the following treatments (IVC, LNHD, NIV (CPAP, BiPAP or any other mode with two pressure levels), MV(reintubation or tracheotomy)). | within 48 hours | 
| Median length of stay in paediatric intensive care |  | Up to 28 days |