- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04410757
Point of Care Ultrasound Evaluation in the Post-Anesthesia Unit
August 27, 2020 updated by: Davinder Ramsingh, MD, Loma Linda University
Point of Care Ultrasound Evaluation in the Post-Anesthesia Unit- A Collaborative Observational Study Between UCLA and Loma Linda University Medical Centers
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).
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
128
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Loma Linda, California, United States, 92354
- Loma Linda University Department of Anesthesiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- Patients in the post-anesthesia care unit with the following events
- 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.
Exclusion Criteria:
- Patients who are not able to have a point of care ultrasound examination in the post anesthesia recovery area.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Point of Care Ultrasound (POCUS) group
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.
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No Point of Care Ultrasound (POCUS) group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post anesthesia care (PACU) unit length of stay (minutes)
Time Frame: during year of the study enrollment
|
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.
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during year of the study enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of diagnosis before and after assessment
Time Frame: during of the study enrollment
|
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..
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during of the study enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2018
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
May 27, 2020
Study Registration Dates
First Submitted
May 27, 2020
First Submitted That Met QC Criteria
May 27, 2020
First Posted (Actual)
June 1, 2020
Study Record Updates
Last Update Posted (Actual)
August 31, 2020
Last Update Submitted That Met QC Criteria
August 27, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5180035
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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