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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care for intubated children with a cuffed endotracheal tube (c-ETT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care for intubated children | Other | Patient ventilated through a cuffed endotracheal tube and having a cuff leak test prior extubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of return to mechanical ventilation (after re-intubation) | 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)). |
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Inclusion Criteria:
Exclusion Criteria:
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Child aged 2 days post-term to 18 years intubated with a cuffed endotracheal tube (c-ETT)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boris Lacarra, Dr | Contact | +33140032187 | boris.lacarra@aphp.fr | |
| Matthieu Resche-Rigon, Pr | Contact | +33142499742 | matthieu.resche-rigon@u-paris.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux Pellegrin | Recruiting | Bordeaux | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38688666 | Derived | 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. |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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, | 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)). | within 48 hours |
| Median length of stay in paediatric intensive care | Up to 28 days |
| Hôpital Haut-Lévêques, maladies cardio-vasculaires congénitales | Recruiting | Bordeaux | France |
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| Hôpital Haut-Lévêques, réanimation chirurgicale cardiopédiatrique | Recruiting | Bordeaux | France |
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| CHU Côte de Nacre | Recruiting | Caen | France |
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| CHU Estaing | Recruiting | Clermont-Ferrand | France |
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| Hôpital Raymond Poincaré | Recruiting | Garches | France |
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| CHU Grenoble Alpes | Recruiting | Grenoble | France |
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| CHU Bicêtre | Recruiting | Le Kremlin-Bicêtre | France |
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| CHU Jeanne de Flandres | Recruiting | Lille | France |
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| Hôpital Femme Mère Enfant HCL | Recruiting | Lyon | France |
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| CHU de La Timone - AP-HM | Recruiting | Marseille | France |
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| CHU Nancy | Recruiting | Nancy | France |
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| CH Marie Lannelongue | Recruiting | Paris | France |
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| Debré, AP-HP Nord | Recruiting | Paris | France |
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| Necker, AP-HP Centre - Anesthésie | Recruiting | Paris | France |
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| Necker, AP-HP Centre - Médecine intensive | Recruiting | Paris | France |
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| Trousseau, AP-HP Est | Recruiting | Paris | France |
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| CHU Toulouse | Recruiting | Toulouse | France |
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| CHU Clocheville | Recruiting | Tours | France |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D012131 | Respiratory Insufficiency |