Air Leak Test In Pediatric Intensive Care Unit

Respiratory Distress Clinical Trial

— ALTIPICU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05328206
• Other study ID #: APHP220207
• Status: Recruiting
• Start date: October 5, 2022
• Est. completion date: April 3, 2024

Study information

• Verified date: May 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Boris Lacarra, Dr
• Phone: +33140032187
• Email: boris.lacarra[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: April 3, 2024
• Est. primary completion date: March 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Days to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Obstruction
• Respiratory Distress
• Upper Airway Obstruction

Intervention

Other:
• Standard of care for intubated children
Patient ventilated through a cuffed endotracheal tube and having a cuff leak test prior extubation

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cumulative incidence of return to mechanical ventilation (after re-intubation)		within 48 hours
Secondary	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)).	within 48 hours
Secondary	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,	at inclusion
Secondary	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)).	within 48 hours
Secondary	Median length of stay in paediatric intensive care		Up to 28 days