Respiratory Distress, Upper Airway Obstruction
Conditions
Brief 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.
Interventions
OTHERStandard of care for intubated children
Patient ventilated through a cuffed endotracheal tube and having a cuff leak test prior extubation
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Days to 17 Years
Healthy volunteers
No
Inclusion criteria
1. ≥ 2 day to \< 18 years of age, 2. Ventilated through a cuffed endotracheal tube, 3. Expected duration of mechanical ventilation ≥ 24 hours, 4. Having a cuff leak test prior extubation, 5. Placed on the assist control setting during CLT, 6. No opposition from parents or patient
Exclusion criteria
1. Receiving mechanical ventilation via a tracheostomy, 2. Unplanned extubation, 3. Patient with long-term non-invasive ventilation (NIV), 4. History of upper airways pathology, 5. Surgery of upper airways less than 1 month old, 6. Limitations of medical care in place, 7. Parents or patient opposition, 8. Already been included in this study, 9. Not affiliated with social security.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory distress by post-extubation upper airway obstruction (UAO) | within 48 hours | 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)). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of return to mechanical ventilation (after re-intubation) | within 48 hours | — |
| Risk factors of severe respiratory distress (RD) | within 48 hours | 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)). |
| Proportion of patients with intravenous corticosteroid therapy (IVC) | at inclusion | Proportion of patients with intravenous corticosteroid therapy (IVC) in progress 12 hours prior to scheduled extubation, whether initiated for extubation or pre-extubation, |
| Predictive score for severe respiratory distress (RD) | within 48 hours | 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)). |
| Median length of stay in paediatric intensive care | Up to 28 days | — |
Countries
France
Contacts
Primary ContactBoris Lacarra, Dr
Backup ContactMatthieu Resche-Rigon, Pr
Outcome results
None listed