Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-31 @ 3:50 AM
Study NCT ID:
NCT05978635
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2023-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Goal Directed Numeric Coaching as a Means of Preoxygenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Once an adequate seal with consistent end tidal carbon dioxide on capnography is achieved, time starts. Patients are divided into two groups:\n\nGroup A: Anesthesia provider encourages patient to breathe deeply by intermittently stating "take as deep a breath as you can". No goal directed numeric coaching is given. End point is 80% expired oxygen. The time it takes to achieve this end point and breath volumes are recorded.\n\nGroup B: Anesthesia provider gives goal directed numeric coaching. For example, if the initial tidal volume achieved by the patient is 500mL, the provider states, "that was a 500mL breath, now try to achieve a 1000mL breath". The numeric goal should continue to increase above the patient\'s actual tidal volume (volume moved in and out of lungs during normal, quiet breathing) until an end point of 80% is reached. The time it takes to achieve this end point and breath volumes are recorded.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-30', 'studyFirstSubmitDate': '2023-07-12', 'studyFirstSubmitQcDate': '2023-07-30', 'lastUpdatePostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vital capacity breaths measured in milliliters', 'timeFrame': 'Pre oxygenation period prior to induction of general anesthesia', 'description': 'Measured vital capacity breaths volume in milliliters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pre-oxygenation, vital capacity breaths'], 'conditions': ['Pre-oxygenation']}, 'descriptionModule': {'briefSummary': 'Pre-oxygenation is an anesthetic technique that allows for extended apneic (suspension of breathing) time prior to attempted endotracheal intubation. A common method to achieve adequate pre-oxygenation is having a patient take four vital capacity breaths of 100% oxygen in thirty seconds. This study seeks to determine if goal directed numeric coaching can lead to more accurate vital capacities during this technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists Physical Status 1 and 2\n* nonsmokers\n* primary English speaking\n* undergoing elective surgery with planned endotracheal intubation\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05978635', 'briefTitle': 'Goal Directed Numeric Coaching as a Means of Preoxygenation', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Goal Directed Numeric Coaching as a Means of Preoxygenation', 'orgStudyIdInfo': {'id': '16D.091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group A', 'description': 'Anesthesia provider asks the patient to take 4 deep breaths by intermittently stating "take as deep a breath as you can". This is the standard of care technique for preoxygenation before induction of general anesthesia with the end point being 80% expired oxygen. The breath volumes in milliliters are recorded but not stated to the patient.', 'interventionNames': ['Behavioral: Group A Standard 4 deep breaths measured in milliliters from the ventilator.']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Anesthesia provider asks the patient to take 4 deep breaths but provides coaching by informing the patient of the numeric volume (milliliters) to reach for every breath. Each tidal volume breath is measured using the anesthesia ventilator and the provider encourages the patient to achieve a higher tidal volume than previously achieved. For example, if the initial tidal volume achieved by the patient is 500 milliliter, the provider states, "that was a 500 milliliter breath, now try to achieve a 1000mL breath". The numeric goal should continue to increase above the patient\'s actual tidal volume. The breath volumes are recorded.', 'interventionNames': ['Behavioral: Group B Coached 4 deep breaths measured in milliliters from the ventilator']}], 'interventions': [{'name': 'Group A Standard 4 deep breaths measured in milliliters from the ventilator.', 'type': 'BEHAVIORAL', 'description': 'Tidal volume breath measured in milliliters', 'armGroupLabels': ['Group A']}, {'name': 'Group B Coached 4 deep breaths measured in milliliters from the ventilator', 'type': 'BEHAVIORAL', 'description': 'Coached tidal volume breath measured in milliliters', 'armGroupLabels': ['Group B']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor of Osteopathic Medicine', 'investigatorFullName': 'Stephen McNulty', 'investigatorAffiliation': 'Thomas Jefferson University'}}}}