Respiratory DistressALTIPICUNCT05328206
Air Leak Test In Pediatric Intensive Care Unit
An observational study of Respiratory Distress and Upper Airway Obstruction, run by Assistance Publique - Hôpitaux de Paris at 19 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 days to 17 years
- Conditions the study is for
- Respiratory Distress, Upper Airway Obstruction
- How many people
- 900 participants
- Where
- 19 sitesFrance
- Study dates
- 5 Oct 2022to 3 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 days to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Child aged 2 days post-term to 18 years intubated with a cuffed endotracheal tube (c-ETT)
Who may be able to join
- ≥ 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
Who cannot join
- 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,
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- Parents or patient opposition,
- Already been included in this study,
- Not affiliated with social security.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites, 19 recruiting
- Recruiting
CHU Bordeaux Pellegrin
Bordeaux
Olivier Brissaud
- Recruiting
Hôpital Haut-Lévêques, maladies cardio-vasculaires congénitales
Bordeaux
Julien Gotchac
- Recruiting
Hôpital Haut-Lévêques, réanimation chirurgicale cardiopédiatrique
Bordeaux
Elise Langouet
- Recruiting
CHU Côte de Nacre
Caen
David Brossier
- Recruiting
CHU Estaing
Clermont-Ferrand
Nadia Savy
- Recruiting
Hôpital Raymond Poincaré
Garches
Justine Zini
- Recruiting
CHU Grenoble Alpes
Grenoble
Guillaume Mortamet
- Recruiting
CHU Bicêtre
Le Kremlin-Bicêtre
Pierre Tissière
- Recruiting
CHU Jeanne de Flandres
Lille
Stéphane Leteurtre
- Recruiting
Hôpital Femme Mère Enfant HCL
Lyon
Robin Pouyau
- Recruiting
CHU de La Timone - AP-HM
Marseille
Fabrice Michel
- Recruiting
CHU Nancy
Nancy
Arnaud Wiedemann
- Recruiting
CH Marie Lannelongue
Paris
Angèle Boët
- Recruiting
Debré, AP-HP Nord
Paris
Boris Lacarra
- Recruiting
Necker, AP-HP Centre - Anesthésie
Paris
Juliette Montmayeur
- Recruiting
Necker, AP-HP Centre - Médecine intensive
Paris
Sylvain Renolleau
- Recruiting
Trousseau, AP-HP Est
Paris
Jérôme Rambaud
- Recruiting
CHU Toulouse
Toulouse
Marie-Odile Marcoux
- Recruiting
CHU Clocheville
Tours
Julie Chantreuil
About this study
Official title: 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.
Read more
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.
- Conditions
- Respiratory Distress, Upper Airway Obstruction
- Being tested
- Standard of care for intubated children
- Medical subject headings
- Dyspnea, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care for intubated childrenOther
Patient ventilated through a cuffed endotracheal tube and having a cuff leak test prior extubation
| Study group | Role | What they receive |
|---|---|---|
| Standard of care for intubated children with a cuffed endotracheal tube (c-ETT) | Not described Receives: Other: Standard of care for intubated children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: within 48 hours
Secondary outcomes (5)
Cumulative incidence of return to mechanical ventilation (after re-intubation)
Measured: within 48 hours
Risk factors of severe respiratory distress (RD)
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)).
Measured: within 48 hours
Proportion of patients with intravenous corticosteroid therapy (IVC)
Proportion of patients with intravenous corticosteroid therapy (IVC) in progress 12 hours prior to scheduled extubation, whether initiated for extubation or pre-extubation,
Measured: at inclusion
Predictive score for severe respiratory distress (RD)
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)).
Measured: within 48 hours
Median length of stay in paediatric intensive care
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start5 Oct 2022
- Primary completion7 Mar 2024 (estimated)
- Study completion3 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory DistressStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328206
- Sponsor's protocol ID
- APHP220207
- Acronym
- ALTIPICU
- Status last verified
- May 2023
- First submitted
- 4 Mar 2022
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38688666
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Leak Test in Pediatric Intensive Care Unit : a Multicentric and Prospective Study
- ClinicalTrials.gov ID
- NCT05328206
- Acronym / sponsor ID
- ALTIPICU / APHP220207
- Conditions
- Respiratory Distress, Upper Airway Obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 7 Mar 2024 (estimated)
- Study completion
- 3 Apr 2024 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care for intubated children with a cuffed endotracheal tube (c-ETT) | – | Other: Standard of care for intubated children |
Who may qualify
- Ages
- 2 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Child aged 2 days post-term to 18 years intubated with a cuffed endotracheal tube (c-ETT)
Key inclusion criteria (6 listed)
- ≥ 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care for intubated childrenPatient ventilated through a cuffed endotracheal tube and having a cuff leak test prior extubation | Other | Standard of care for intubated children with a cuffed endotracheal tube (c-ETT) |
Primary outcome
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)).
5 secondary outcomes
Cumulative incidence of return to mechanical ventilation (after re-intubation)
Time frame: within 48 hours
Risk factors of severe respiratory distress (RD)
Time frame: within 48 hours
Proportion of patients with intravenous corticosteroid therapy (IVC)
Time frame: at inclusion
Predictive score for severe respiratory distress (RD)
Time frame: within 48 hours
Median length of stay in paediatric intensive care
Time frame: Up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 38688666Lacarra 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress and Upper Airway Obstruction, run by Assistance Publique - Hôpitaux de Paris at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boris Lacarra, Dr (+33140032187, boris.lacarra@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory distress by post-extubation upper airway obstruction (UAO) (time frame: within 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05328206, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.