Air Leak Test In Pediatric Intensive Care Unit
ALTIPICU
Air Leak Test in Pediatric Intensive Care Unit : a Multicentric and Prospective Study
1 other identifier
observational
900
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2022
CompletedFirst Posted
Study publicly available on registry
April 14, 2022
CompletedStudy Start
First participant enrolled
October 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2024
CompletedMay 11, 2023
May 1, 2023
1.4 years
March 4, 2022
May 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Cumulative incidence of return to mechanical ventilation (after re-intubation)
within 48 hours
Risk factors of severe respiratory distress (RD)
within 48 hours
Proportion of patients with intravenous corticosteroid therapy (IVC)
at inclusion
Predictive score for severe respiratory distress (RD)
within 48 hours
Median length of stay in paediatric intensive care
Up to 28 days
Study Arms (1)
Standard of care for intubated children with a cuffed endotracheal tube (c-ETT)
Interventions
Patient ventilated through a cuffed endotracheal tube and having a cuff leak test prior extubation
Eligibility Criteria
Child aged 2 days post-term to 18 years intubated with a cuffed endotracheal tube (c-ETT)
You may qualify if:
- ≥ 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
CHU Bordeaux Pellegrin
Bordeaux, France
Hôpital Haut-Lévêques, maladies cardio-vasculaires congénitales
Bordeaux, France
Hôpital Haut-Lévêques, réanimation chirurgicale cardiopédiatrique
Bordeaux, France
CHU Côte de Nacre
Caen, France
CHU Estaing
Clermont-Ferrand, France
Hôpital Raymond Poincaré
Garches, France
CHU Grenoble Alpes
Grenoble, France
CHU Bicêtre
Le Kremlin-Bicêtre, France
CHU Jeanne de Flandres
Lille, France
Hôpital Femme Mère Enfant HCL
Lyon, France
CHU de La Timone - AP-HM
Marseille, France
CHU Nancy
Nancy, France
CH Marie Lannelongue
Paris, France
Debré, AP-HP Nord
Paris, France
Necker, AP-HP Centre - Anesthésie
Paris, France
Necker, AP-HP Centre - Médecine intensive
Paris, France
Trousseau, AP-HP Est
Paris, France
CHU Toulouse
Toulouse, France
CHU Clocheville
Tours, France
Related Publications (1)
Lacarra B, Hayotte A, Naudin J, Maroni A, Geslain G, Poncelet G, Levy M, Resche-Rigon M, Dauger S. Air leak test in the Paediatric Intensive Care Unit (ALTIPICU): rationale and protocol for a prospective multicentre observational study. BMJ Open. 2024 Apr 30;14(4):e081314. doi: 10.1136/bmjopen-2023-081314.
PMID: 38688666DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2022
First Posted
April 14, 2022
Study Start
October 5, 2022
Primary Completion
March 7, 2024
Study Completion
April 3, 2024
Last Updated
May 11, 2023
Record last verified: 2023-05