Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
Study NCT ID:
NCT05328206
Status:
UNKNOWN
Last Update Posted:
2023-05-11
First Post:
2022-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Air Leak Test In Pediatric Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D000402', 'term': 'Airway Obstruction'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-04-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2022-03-04', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory distress by post-extubation upper airway obstruction (UAO)', 'timeFrame': 'within 48 hours', 'description': '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)).'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of return to mechanical ventilation (after re-intubation)', 'timeFrame': 'within 48 hours'}, {'measure': 'Risk factors of severe respiratory distress (RD)', 'timeFrame': 'within 48 hours', 'description': '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)).'}, {'measure': 'Proportion of patients with intravenous corticosteroid therapy (IVC)', 'timeFrame': 'at inclusion', 'description': 'Proportion of patients with intravenous corticosteroid therapy (IVC) in progress 12 hours prior to scheduled extubation, whether initiated for extubation or pre-extubation,'}, {'measure': 'Predictive score for severe respiratory distress (RD)', 'timeFrame': 'within 48 hours', 'description': '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)).'}, {'measure': 'Median length of stay in paediatric intensive care', 'timeFrame': 'Up to 28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Distress', 'Upper Airway Obstruction']}, 'referencesModule': {'references': [{'pmid': '38688666', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Respiratory distress by upper airway obstruction (UAO) is the primary etiology of extubation failure in children hospitalized in pediatric intensive care unit (PICU).\n\nThis complication may require various invasive therapeutic which increase morbi-mortality and length of hospital stay.\n\nCuff 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.\n\nDespite its frequent use in PICU, his predictive value to predict UAO in children is still poorly documented.\n\nTherefore, we conducted the first multicentric, prospective study to evaluate the CLT as a predictor of post-extubation UAO in critically ill children.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Child aged 2 days post-term to 18 years intubated with a cuffed endotracheal tube (c-ETT)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 2 day to \\< 18 years of age,\n2. Ventilated through a cuffed endotracheal tube,\n3. Expected duration of mechanical ventilation ≥ 24 hours,\n4. Having a cuff leak test prior extubation,\n5. Placed on the assist control setting during CLT,\n6. No opposition from parents or patient\n\nExclusion Criteria:\n\n1. Receiving mechanical ventilation via a tracheostomy,\n2. Unplanned extubation,\n3. Patient with long-term non-invasive ventilation (NIV),\n4. History of upper airways pathology,\n5. Surgery of upper airways less than 1 month old,\n6. Limitations of medical care in place,\n7. Parents or patient opposition,\n8. Already been included in this study,\n9. Not affiliated with social security.'}, 'identificationModule': {'nctId': 'NCT05328206', 'acronym': 'ALTIPICU', 'briefTitle': 'Air Leak Test In Pediatric Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Air Leak Test in Pediatric Intensive Care Unit : a Multicentric and Prospective Study', 'orgStudyIdInfo': {'id': 'APHP220207'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard of care for intubated children with a cuffed endotracheal tube (c-ETT)', 'interventionNames': ['Other: Standard of care for intubated children']}], 'interventions': [{'name': 'Standard of care for intubated children', 'type': 'OTHER', 'description': 'Patient ventilated through a cuffed endotracheal tube and having a cuff leak test prior extubation', 'armGroupLabels': ['Standard of care for intubated children with a cuffed endotracheal tube (c-ETT)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Brissaud', 'role': 'CONTACT'}], 'facility': 'CHU Bordeaux Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Gotchac', 'role': 'CONTACT'}], 'facility': 'Hôpital Haut-Lévêques, maladies cardio-vasculaires congénitales', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elise Langouet', 'role': 'CONTACT'}], 'facility': 'Hôpital Haut-Lévêques, réanimation chirurgicale cardiopédiatrique', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David Brossier', 'role': 'CONTACT'}], 'facility': 'CHU Côte de Nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nadia Savy', 'role': 'CONTACT'}], 'facility': 'CHU Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Garches', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Justine Zini', 'role': 'CONTACT'}], 'facility': 'Hôpital Raymond Poincaré', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume Mortamet', 'role': 'CONTACT'}], 'facility': 'CHU Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Tissière', 'role': 'CONTACT'}], 'facility': 'CHU Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane Leteurtre', 'role': 'CONTACT'}], 'facility': 'CHU Jeanne de Flandres', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Robin Pouyau', 'role': 'CONTACT'}], 'facility': 'Hôpital Femme Mère Enfant HCL', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrice Michel', 'role': 'CONTACT'}], 'facility': 'CHU de La Timone - AP-HM', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arnaud Wiedemann', 'role': 'CONTACT'}], 'facility': 'CHU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Angèle Boët', 'role': 'CONTACT'}], 'facility': 'CH Marie Lannelongue', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Boris Lacarra', 'role': 'CONTACT'}], 'facility': 'Debré, AP-HP Nord', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Juliette Montmayeur', 'role': 'CONTACT'}], 'facility': 'Necker, AP-HP Centre - Anesthésie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvain Renolleau', 'role': 'CONTACT'}], 'facility': 'Necker, AP-HP Centre - Médecine intensive', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérôme Rambaud', 'role': 'CONTACT'}], 'facility': 'Trousseau, AP-HP Est', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Odile Marcoux', 'role': 'CONTACT'}], 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie Chantreuil', 'role': 'CONTACT'}], 'facility': 'CHU Clocheville', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Boris Lacarra, Dr', 'role': 'CONTACT', 'email': 'boris.lacarra@aphp.fr', 'phone': '+33140032187'}, {'name': 'Matthieu Resche-Rigon, Pr', 'role': 'CONTACT', 'email': 'matthieu.resche-rigon@u-paris.fr', 'phone': '+33142499742'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}