Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-13 @ 12:59 PM
Study NCT ID:
NCT04410757
Status:
COMPLETED
Last Update Posted:
2020-08-31
First Post:
2020-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point of Care Ultrasound Evaluation in the Post-Anesthesia Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D009846', 'term': 'Oliguria'}, {'id': 'D002637', 'term': 'Chest Pain'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-27', 'studyFirstSubmitDate': '2020-05-27', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post anesthesia care (PACU) unit length of stay (minutes)', 'timeFrame': 'during year of the study enrollment', 'description': 'The primary outcome marker for the study was post anesthesia care (PACU) unit length of stay (minutes), with a hypothesis that patients receiving a POCUS examination for the cardiovascular or pulmonary event would have a shorter PACU LOS.'}], 'secondaryOutcomes': [{'measure': 'number of diagnosis before and after assessment', 'timeFrame': 'during of the study enrollment', 'description': 'Additional markers include a POCUS report completed by the performing attending anesthesiologist that included POCUS findings and the number of potential diagnoses to explain the acute event (hypoxia and/or hypotension) before and after the POCUS exam was performed..'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypotension', 'Hypoxemia', 'Altered Mental Status', 'Urine Output Low', 'Chest Pain']}, 'referencesModule': {'references': [{'pmid': '26181338', 'type': 'BACKGROUND', 'citation': 'Ramsingh D, Rinehart J, Kain Z, Strom S, Canales C, Alexander B, Capatina A, Ma M, Le KV, Cannesson M. Impact assessment of perioperative point-of-care ultrasound training on anesthesiology residents. Anesthesiology. 2015 Sep;123(3):670-82. doi: 10.1097/ALN.0000000000000776.'}, {'pmid': '22352785', 'type': 'BACKGROUND', 'citation': 'Canty DJ, Royse CF, Kilpatrick D, Bowman L, Royse AG. The impact of focused transthoracic echocardiography in the pre-operative clinic. Anaesthesia. 2012 Jun;67(6):618-25. doi: 10.1111/j.1365-2044.2012.07074.x. Epub 2012 Feb 21.'}, {'pmid': '27828799', 'type': 'BACKGROUND', 'citation': 'Ford JW, Heiberg J, Brennan AP, Royse CF, Canty DJ, El-Ansary D, Royse AG. A Pilot Assessment of 3 Point-of-Care Strategies for Diagnosis of Perioperative Lung Pathology. Anesth Analg. 2017 Mar;124(3):734-742. doi: 10.1213/ANE.0000000000001726.'}, {'pmid': '27551733', 'type': 'BACKGROUND', 'citation': 'Haskins SC, Desai NA, Fields KG, Nejim JA, Cheng S, Coleman SH, Nawabi DH, Kelly BT. Diagnosis of Intraabdominal Fluid Extravasation After Hip Arthroscopy With Point-of-Care Ultrasonography Can Identify Patients at an Increased Risk for Postoperative Pain. Anesth Analg. 2017 Mar;124(3):791-799. doi: 10.1213/ANE.0000000000001435.'}, {'pmid': '25951832', 'type': 'BACKGROUND', 'citation': 'Perlas A, Van de Putte P, Van Houwe P, Chan VW. I-AIM framework for point-of-care gastric ultrasound. Br J Anaesth. 2016 Jan;116(1):7-11. doi: 10.1093/bja/aev113. Epub 2015 May 7. No abstract available.'}, {'pmid': '26575653', 'type': 'BACKGROUND', 'citation': 'Shokoohi H, Boniface KS, Pourmand A, Liu YT, Davison DL, Hawkins KD, Buhumaid RE, Salimian M, Yadav K. Bedside Ultrasound Reduces Diagnostic Uncertainty and Guides Resuscitation in Patients With Undifferentiated Hypotension. Crit Care Med. 2015 Dec;43(12):2562-9. doi: 10.1097/CCM.0000000000001285.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this observational research study is to examine how point-of care ultrasound affects the workup and management of perioperative complications for specific clinical scenarios of low blood pressure (hypotension), low blood oxygen (hypoxemia), in the post- anesthesia care unit (PACU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatient or outpatient subjects from the age 18 and above with no maximum age limit admitted in the post-anesthesia care unit (PACU) that experienced a hypoxic or hypotensive event and were examined by a physician.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in the post-anesthesia care unit with the following events\n* Mean arterial blood pressure \\<60 mmHg or \\<20% of pre-operative baseline mean arterial blood pressure,) hypoxemia (pulse oximetry saturation \\<95% or Pao2 \\<80), altered mental status, decreased urine output, chest pain/EKG changes, or to confirm endotracheal Lube placement.\n\nExclusion Criteria:\n\n* Patients who are not able to have a point of care ultrasound examination in the post anesthesia recovery area.'}, 'identificationModule': {'nctId': 'NCT04410757', 'briefTitle': 'Point of Care Ultrasound Evaluation in the Post-Anesthesia Unit', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Point of Care Ultrasound Evaluation in the Post-Anesthesia Unit- A Collaborative Observational Study Between UCLA and Loma Linda University Medical Centers', 'orgStudyIdInfo': {'id': '5180035'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Point of Care Ultrasound (POCUS) group', 'description': 'When the provider in charge of covering the post-anesthesia care unit, they would apply POCUS examinations in their PACU assessment as per the study protocol of hypotensive and hypoxic events.'}, {'label': 'No Point of Care Ultrasound (POCUS) group', 'description': 'When the provider in charge of covering the post-anesthesia care unit, they would apply routine bedside examination techniques in their PACU assessment as per the study protocol of hypotensive and hypoxic events.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Department of Anesthesiology', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Davinder Ramsingh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Clinical Research', 'investigatorFullName': 'Davinder Ramsingh, MD', 'investigatorAffiliation': 'Loma Linda University'}}}}