Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
900 participants
OBSERVATIONAL
2022-10-05
2024-04-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard of care for intubated children with a cuffed endotracheal tube (c-ETT)
Standard of care for intubated children
Patient ventilated through a cuffed endotracheal tube and having a cuff leak test prior extubation
Interventions
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Standard of care for intubated children
Patient ventilated through a cuffed endotracheal tube and having a cuff leak test prior extubation
Eligibility Criteria
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Inclusion Criteria
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
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.
2 Days
17 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Olivier Brissaud
Role: primary
Julien Gotchac
Role: primary
Elise Langouet
Role: primary
David Brossier
Role: primary
Nadia Savy
Role: primary
Justine Zini
Role: primary
Guillaume Mortamet
Role: primary
Pierre Tissière
Role: primary
Stéphane Leteurtre
Role: primary
Robin Pouyau
Role: primary
Fabrice Michel
Role: primary
Arnaud Wiedemann
Role: primary
Angèle Boët
Role: primary
Boris Lacarra
Role: primary
Juliette Montmayeur
Role: primary
Sylvain Renolleau
Role: primary
Jérôme Rambaud
Role: primary
Marie-Odile Marcoux
Role: primary
Julie Chantreuil
Role: primary
References
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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.
Other Identifiers
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APHP220207
Identifier Type: -
Identifier Source: org_study_id
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