NCT04410757

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

May 27, 2020

Last Update Submit

August 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • number of diagnosis before and after assessment

    during of the study enrollment

Study Arms (2)

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who are not able to have a point of care ultrasound examination in the post anesthesia recovery area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Department of Anesthesiology

Loma Linda, California, 92354, United States

Location

Related Publications (6)

  • 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: 26181338BACKGROUND
  • 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: 22352785BACKGROUND
  • 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: 27828799BACKGROUND
  • 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: 27551733BACKGROUND
  • 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: 25951832BACKGROUND
  • 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.

    PMID: 26575653BACKGROUND

MeSH Terms

Conditions

HypotensionHypoxiaOliguriaChest Pain

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsPainNeurologic Manifestations

Study Officials

  • Davinder Ramsingh, MD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Research

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 1, 2020

Study Start

August 1, 2018

Primary Completion

August 1, 2019

Study Completion

May 27, 2020

Last Updated

August 31, 2020

Record last verified: 2020-08

Locations