Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-27 @ 1:45 AM
Study NCT ID:
NCT05361850
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2022-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Deep Versus Awake Tracheal Extubation in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D060666', 'term': 'Airway Extubation'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-03', 'studyFirstSubmitDate': '2022-04-23', 'studyFirstSubmitQcDate': '2022-04-30', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aggregate Rate of Airway and Respiratory Complications', 'timeFrame': 'Peri-extubation period', 'description': 'Coughing, obstruction, apnea, hypoxemia, bronchospasm, laryngospasm, aspiration'}], 'secondaryOutcomes': [{'measure': 'Incidence and Severity of Postoperative Sore Throat', 'timeFrame': 'At time of transfer from PACU Phase 1 to PACU Phase 2 once PACU Phase 1 discharge criteria met, minimum of twenty minutes', 'description': 'Sore Throat Rated on 0-10 Visual Analog Scale'}, {'measure': 'Peri-extubation Heart Rate', 'timeFrame': 'Peri-extubation period', 'description': 'Beats per minute, Incidence and Severity of Tachycardia (defined as 20% from Baseline Heart Rate)'}, {'measure': 'Peri-extubation Blood Pressure', 'timeFrame': 'Peri-extubation period', 'description': 'Systolic, Diastolic, and Mean Arterial Pressure in Millimeters of Mercury by Non-Invasive Blood Pressure, Incidence and Severity of Hypertension and Hypotension (defined as 20% from Baseline Blood Pressure)'}, {'measure': 'End-of-Surgery to Out-Of-Room Time', 'timeFrame': 'From End-of-Surgery Time (defined by surgical dressing application) to Out-of-Room Time (defined by patient physically leaving operating room), up to two hours', 'description': 'Duration in Minutes'}, {'measure': 'Peri-extubation Agitation', 'timeFrame': 'From ten minutes prior to extubation to transfer time from PACU Phase 1 to PACU Phase 2 (minimum PACU Phase 1 stay 20 minutes)', 'description': 'Incidence of Richmond Agitation-Sedation Scale score \\>=2'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Awake Extubation', 'Deep Extubation'], 'conditions': ['Airway Complication of Anesthesia', 'Respiratory Complications of Care']}, 'referencesModule': {'references': [{'pmid': '40745279', 'type': 'DERIVED', 'citation': 'Lee MA, Schenke PW, Faller MR, DeYoung HR, Adams AR. A comparison of deep versus awake tracheal extubation in adults: a randomized controlled trial. BMC Anesthesiol. 2025 Jul 31;25(1):387. doi: 10.1186/s12871-025-03224-6.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status classification system for assessing the fitness of patients before surgery 1-3\n* Meeting American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting\n* Adult patients age 18-64\n* Favorable airway examinations (Mallampati 1 or 2, normal mouth opening, and intact neck extension)\n* Scheduled cases in which tracheal intubation and general anesthesia are indicated\n\nExclusion Criteria:\n\n* Patients with chronic obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infections, and/or uncontrolled asthma\n* Unfavorable airway examinations (Mallampati 3 or 4, limited mouth opening, and/or inability to extend neck)\n* Full stomach\n* Known difficult intubation or mask ventilation\n* Surgeries of the airway and intrathoracic surgeries\n* Emergent surgeries\n* Case duration \\>6 hours\n* Pregnancy\n* Patients scheduled to receive a protocolized anesthetic (Enhanced Recovery After Surgery aka ERAS)\n* ASA Physical Status Classification 4 or 5\n* Chronic diseases such as obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infections, and/or uncontrolled asthma\n* Uncontrolled gastroesophageal reflux disease (heartburn) defined by presence of symptoms despite compliance with appropriate medication regimen\n* Patient scheduled to receive a protocolized anesthetic ie Enhanced Recovery After Anesthesia (ERAS)\n* Surgeries requiring prone positioning'}, 'identificationModule': {'nctId': 'NCT05361850', 'acronym': 'CDATE', 'briefTitle': 'Comparison of Deep Versus Awake Tracheal Extubation in Adults', 'organization': {'class': 'FED', 'fullName': 'United States Navy'}, 'officialTitle': 'Comparison of Deep Versus Awake Tracheal Extubation in Adults', 'orgStudyIdInfo': {'id': 'NMCP.2020.0097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Awake Extubation', 'description': 'Removal of the endotracheal tube while the patient is no longer under general anesthesia', 'interventionNames': ['Procedure: Extubation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Deep Extubation', 'description': 'Removal of the endotracheal tube while the patient is under general anesthesia', 'interventionNames': ['Procedure: Extubation']}], 'interventions': [{'name': 'Extubation', 'type': 'PROCEDURE', 'description': 'Removal of the endotracheal tube', 'armGroupLabels': ['Awake Extubation', 'Deep Extubation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23708', 'city': 'Portsmouth', 'state': 'Virginia', 'country': 'United States', 'facility': 'Naval Medical Center Portsmouth', 'geoPoint': {'lat': 36.83543, 'lon': -76.29827}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Navy', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Anesthesiologist', 'investigatorFullName': 'Michael Andrew Lee', 'investigatorAffiliation': 'United States Navy'}}}}