Air Leak Test In Pediatric Intensive Care Unit (ALTIPICU)

May 9, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Air Leak Test in Pediatric Intensive Care Unit : a Multicentric and Prospective Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • CHU Bordeaux Pellegrin
        • Contact:
          • Olivier Brissaud
      • Bordeaux, France
        • Recruiting
        • Hôpital Haut-Lévêques, maladies cardio-vasculaires congénitales
        • Contact:
          • Julien Gotchac
      • Bordeaux, France
        • Recruiting
        • Hôpital Haut-Lévêques, réanimation chirurgicale cardiopédiatrique
        • Contact:
          • Elise Langouet
      • Caen, France
        • Recruiting
        • CHU côte de Nacre
        • Contact:
          • David Brossier
      • Clermont-Ferrand, France
        • Recruiting
        • CHU Estaing
        • Contact:
          • Nadia Savy
      • Garches, France
        • Recruiting
        • Hôpital Raymond Poincaré
        • Contact:
          • Justine Zini
      • Grenoble, France
        • Recruiting
        • Chu Grenoble Alpes
        • Contact:
          • Guillaume Mortamet
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • CHU Bicêtre
        • Contact:
          • Pierre Tissière
      • Lille, France
        • Recruiting
        • CHU Jeanne de Flandres
        • Contact:
          • Stéphane Leteurtre
      • Lyon, France
        • Recruiting
        • Hôpital Femme Mère Enfant HCL
        • Contact:
          • Robin Pouyau
      • Marseille, France
        • Recruiting
        • CHU de La Timone - AP-HM
        • Contact:
          • Fabrice Michel
      • Nancy, France
        • Recruiting
        • CHU Nancy
        • Contact:
          • Arnaud Wiedemann
      • Paris, France
        • Recruiting
        • CH Marie Lannelongue
        • Contact:
          • Angèle Boët
      • Paris, France
        • Recruiting
        • Debré, AP-HP Nord
        • Contact:
          • Boris Lacarra
      • Paris, France
        • Recruiting
        • Necker, AP-HP Centre - Anesthésie
        • Contact:
          • Juliette Montmayeur
      • Paris, France
        • Recruiting
        • Necker, AP-HP Centre - Médecine intensive
        • Contact:
          • Sylvain Renolleau
      • Paris, France
        • Recruiting
        • Trousseau, AP-HP Est
        • Contact:
          • Jérôme Rambaud
      • Toulouse, France
        • Recruiting
        • CHU Toulouse
        • Contact:
          • Marie-Odile Marcoux
      • Tours, France
        • Recruiting
        • CHU Clocheville
        • Contact:
          • Julie Chantreuil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 17 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Child aged 2 days post-term to 18 years intubated with a cuffed endotracheal tube (c-ETT)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard of care for intubated children with a cuffed endotracheal tube (c-ETT)
Other: Standard of care for intubated children
Patient ventilated through a cuffed endotracheal tube and having a cuff leak test prior extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory distress by post-extubation upper airway obstruction (UAO)
Time Frame: within 48 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of return to mechanical ventilation (after re-intubation)
Time Frame: within 48 hours
within 48 hours
Risk factors of severe respiratory distress (RD)
Time Frame: within 48 hours
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
Proportion of patients with intravenous corticosteroid therapy (IVC)
Time Frame: at inclusion
Proportion of patients with intravenous corticosteroid therapy (IVC) in progress 12 hours prior to scheduled extubation, whether initiated for extubation or pre-extubation,
at inclusion
Predictive score for severe respiratory distress (RD)
Time Frame: within 48 hours
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
Median length of stay in paediatric intensive care
Time Frame: Up to 28 days
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2022

Primary Completion (Anticipated)

March 7, 2024

Study Completion (Anticipated)

April 3, 2024

Study Registration Dates

First Submitted

March 4, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP220207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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