Air Leak Test In Pediatric Intensive Care Unit (ALTIPICU)

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Upper Airway Obstruction
Respiratory Distress

Treatments

Other: Standard of care for intubated children

Study type

Observational

Funder types

Other

Identifiers

NCT05328206
APHP220207

Details and patient eligibility

About

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.

Enrollment

900 estimated patients

Sex

All

Ages

2 days to 17 years old

Volunteers

No Healthy Volunteers

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.

Trial design

900 participants in 1 patient group

Standard of care for intubated children with a cuffed endotracheal tube (c-ETT)
Treatment:
Other: Standard of care for intubated children

Trial contacts and locations

19

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Central trial contact

Matthieu Resche-Rigon, Pr; Boris Lacarra, Dr

Data sourced from clinicaltrials.gov

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