Air Leak Test In Pediatric Intensive Care Unit

Last updated: May 9, 2023
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Bronchiectasis

Treatment

Standard of care for intubated children

Clinical Study ID

NCT05328206
APHP220207
  • Ages 2-17
  • All Genders

Study 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

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

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.

Study Design

Total Participants: 900
Treatment Group(s): 1
Primary Treatment: Standard of care for intubated children
Phase:
Study Start date:
October 05, 2022
Estimated Completion Date:
April 03, 2024

Connect with a study center

  • CHU Bordeaux Pellegrin

    Bordeaux,
    France

    Active - Recruiting

  • Hôpital Haut-Lévêques, maladies cardio-vasculaires congénitales

    Bordeaux,
    France

    Active - Recruiting

  • Hôpital Haut-Lévêques, réanimation chirurgicale cardiopédiatrique

    Bordeaux,
    France

    Active - Recruiting

  • CHU Côte de Nacre

    Caen,
    France

    Active - Recruiting

  • CHU Estaing

    Clermont-Ferrand,
    France

    Active - Recruiting

  • Hôpital Raymond Poincaré

    Garches,
    France

    Active - Recruiting

  • CHU Grenoble Alpes

    Grenoble,
    France

    Active - Recruiting

  • CHU Bicêtre

    Le Kremlin-Bicêtre,
    France

    Active - Recruiting

  • CHU Jeanne de Flandres

    Lille,
    France

    Active - Recruiting

  • Hôpital Femme Mère Enfant HCL

    Lyon,
    France

    Active - Recruiting

  • CHU de La Timone - AP-HM

    Marseille,
    France

    Active - Recruiting

  • CHU Nancy

    Nancy,
    France

    Active - Recruiting

  • CH Marie Lannelongue

    Paris,
    France

    Active - Recruiting

  • Debré, AP-HP Nord

    Paris,
    France

    Active - Recruiting

  • Necker, AP-HP Centre - Anesthésie

    Paris,
    France

    Active - Recruiting

  • Necker, AP-HP Centre - Médecine intensive

    Paris,
    France

    Active - Recruiting

  • Trousseau, AP-HP Est

    Paris,
    France

    Active - Recruiting

  • CHU Toulouse

    Toulouse,
    France

    Active - Recruiting

  • CHU Clocheville

    Tours,
    France

    Active - Recruiting

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