Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT02112604
Status:
UNKNOWN
Last Update Posted:
2016-03-17
First Post:
2014-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Upper Airway Function and Sleep-disordered Breathing in the Critically Ill
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012122', 'term': 'Ventilators, Mechanical'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D006993', 'term': 'Hypnotics and Sedatives'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-16', 'studyFirstSubmitDate': '2014-04-10', 'studyFirstSubmitQcDate': '2014-04-11', 'lastUpdatePostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea-hypopnea index (AHI)', 'timeFrame': '1 Night after extubation', 'description': 'The apnea-hypopnea index (AHI) is calculated the night after extubation via a polysomnography device. An AHI ≥ 5 indicates sleep-disordered breathing and obstructive sleep apnea (OSA).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['critically ill, OSA, mechanical ventilation'], 'conditions': ['Critically Ill', 'Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '23584384', 'type': 'BACKGROUND', 'citation': 'Mirzakhani H, Williams JN, Mello J, Joseph S, Meyer MJ, Waak K, Schmidt U, Kelly E, Eikermann M. Muscle weakness predicts pharyngeal dysfunction and symptomatic aspiration in long-term ventilated patients. Anesthesiology. 2013 Aug;119(2):389-97. doi: 10.1097/ALN.0b013e31829373fe.'}, {'pmid': '29182729', 'type': 'DERIVED', 'citation': 'Timm FP, Zaremba S, Grabitz SD, Farhan HN, Zaremba S, Siliski E, Shin CH, Muse S, Friedrich S, Mojica JE, Kurth T, Ramachandran SK, Eikermann M. Effects of Opioids Given to Facilitate Mechanical Ventilation on Sleep Apnea After Extubation in the Intensive Care Unit. Sleep. 2018 Jan 1;41(1). doi: 10.1093/sleep/zsx191.'}]}, 'descriptionModule': {'briefSummary': 'This is part 2 of the #NCT01618240 under the same IRB protocol #2010P001919. The primary objective of this study is to examine factors that are related to sleep-disordered breathing and upper airway patency in critically ill patients who have been recently mechanically ventilated. Our primary hypothesize is that sedatives and neuromuscular blocking agents given in the ICU prior to extubation and during the first night following extubation are associated with sleep-disordered breathing. The secondary hypotheses are that duration of mechanical ventilation, BMI, and muscle strength are associated with sleep-disordered breathing during the night after extubation.\n\nThe secondary objective is to evaluate if sleep-disordered breathing in the ICU can be predicted by standard pulmonary function testing in the ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ventilated patients in the surgical intensive unit (SICU)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients admitted to the SICU\n2. Age over 18 years.\n3. Ventilated patients with an endotracheal tube for at least 24 hours.\n\nExclusion Criteria:\n\n1. Decreased level of consciousness as defined by a Richmond Agitation Sedation Scale (RASS) of 0.\n2. Non-cooperative patient, CAM score positive for risk of delirium.\n3. For women: pregnancy.'}, 'identificationModule': {'nctId': 'NCT02112604', 'briefTitle': 'Predictors of Upper Airway Function and Sleep-disordered Breathing in the Critically Ill', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Determining Predictors of Adequate Upper Airway Function in Ventilated Patients', 'orgStudyIdInfo': {'id': '2010P001919B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ventilated patients', 'description': 'Patients who have been extubated within 24 hours and have been mechanically ventilated for at least 24 hours. Alice PDx, pulmonary function tests, muscle strength tests, grip strength measurements, ventilator, Sedatives and muscle relaxants given in the ICU', 'interventionNames': ['Device: Ventilator', 'Device: Alice PDx', 'Other: Pulmonary function test', 'Other: Muscle strength tests', 'Other: Grip strength measurement', 'Drug: Sedatives and muscle relaxants given in the ICU']}], 'interventions': [{'name': 'Ventilator', 'type': 'DEVICE', 'description': 'Mechanical ventilator used to replace or assist spontaneous breathing.', 'armGroupLabels': ['Ventilated patients']}, {'name': 'Alice PDx', 'type': 'DEVICE', 'description': 'Alice PDx is a polysomnography monitor used to study stages of sleep and detect sleep-disordered breathing. The device monitors PO2, airflow, EEG, EOG and abdominal wall movements to detect sleep apnea.', 'armGroupLabels': ['Ventilated patients']}, {'name': 'Pulmonary function test', 'type': 'OTHER', 'description': 'The pulmonary function tests are used to study upper airway patency.', 'armGroupLabels': ['Ventilated patients']}, {'name': 'Muscle strength tests', 'type': 'OTHER', 'description': 'MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement', 'armGroupLabels': ['Ventilated patients']}, {'name': 'Grip strength measurement', 'type': 'OTHER', 'description': 'Grip strength has been shown to be an accurate means of assessing muscle function in the critically ill. Muscle weakness may have an impact on upper airway patency.', 'armGroupLabels': ['Ventilated patients']}, {'name': 'Sedatives and muscle relaxants given in the ICU', 'type': 'DRUG', 'description': "Patients in the ICU are administered sedatives, anesthetics, opiods, anti-pyschotics and neuromuscular blocking agents as part of routine care. We hypothesize that the use of these drugs is associated with sleep-disordered breathing following extubation. We will collect the drug doses from the patient's chart.", 'armGroupLabels': ['Ventilated patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthias Eikermann, MD, PhD', 'role': 'CONTACT', 'email': 'MEIKERMANN@PARTNERS.ORG', 'phone': '617-643-4408'}, {'name': 'Matthias Eikermann, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Matthias Eikermann, MD, PhD', 'role': 'CONTACT', 'email': 'MEIKERMANN@PARTNERS.ORG', 'phone': '617-643-4408'}], 'overallOfficials': [{'name': 'Matthias Eikermann, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research, Critical Care Division; Associate Professor of Anaesthesia, Harvard Medical School', 'investigatorFullName': 'Matthias Eikermann', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}