Clinical trial NCT05328206: Air Leak Test In Pediatric Intensive Care Unit
Official title: Air Leak Test in Pediatric Intensive Care Unit : a Multicentric and Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Distress
Upper Airway Obstruction
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 900
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child aged 2 days post-term to 18 years intubated with a cuffed endotracheal tube (c-ETT)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Respiratory distress by post-extubation upper airway obstruction (UAO)
timeFrame: within 48 hours
Secondary outcomes:
measure: Cumulative incidence of return to mechanical ventilation (after re-intubation)
timeFrame: within 48 hours
measure: Risk factors of severe respiratory distress (RD)
timeFrame: within 48 hours
measure: Proportion of patients with intravenous corticosteroid therapy (IVC)
timeFrame: at inclusion
measure: Predictive score for severe respiratory distress (RD)
timeFrame: within 48 hours
measure: Median length of stay in paediatric intensive care
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux Pellegrin
city: Bordeaux
country: France
facility: Hôpital Haut-Lévêques, maladies cardio-vasculaires congénitales
city: Bordeaux
country: France
facility: Hôpital Haut-Lévêques, réanimation chirurgicale cardiopédiatrique
city: Caen
country: France
facility: CHU Côte de Nacre
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Garches
country: France
facility: Hôpital Raymond Poincaré
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Le Kremlin-Bicêtre
country: France
facility: CHU Bicêtre
city: Lille
country: France
facility: CHU Jeanne de Flandres
city: Lyon
country: France
facility: Hôpital Femme Mère Enfant HCL
city: Marseille
country: France
facility: CHU de La Timone - AP-HM
city: Nancy
country: France
facility: CHU Nancy
city: Paris
country: France
facility: CH Marie Lannelongue
city: Paris
country: France
facility: Debré, AP-HP Nord
city: Paris
country: France
facility: Necker, AP-HP Centre - Anesthésie
city: Paris
country: France
facility: Necker, AP-HP Centre - Médecine intensive
city: Paris
country: France
facility: Trousseau, AP-HP Est
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Clocheville
Study officials:
References: