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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04410757
Other study ID # 5180035
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date May 27, 2020

Study information

Verified date August 2020
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date May 27, 2020
Est. primary completion date August 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
United States Loma Linda University Department of Anesthesiology Loma Linda California

Sponsors (2)

Lead Sponsor Collaborator
Loma Linda University University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary post anesthesia care (PACU) unit length of stay (minutes) 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. during year of the study enrollment
Secondary number of diagnosis before and after assessment 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.. during of the study enrollment
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