Use of Point-of-care Ultrasound in High Risk Surgical Patients

April 20, 2017 updated by: Jian-jun Yang, Zhongda Hospital

Effects of Perioperative Point-of-care Ultrasound Assessment on Postoperative Outcomes in High Risk Surgical Patients

There is currently a lack of evidence to support the use of perioperative point-of-care ultrasound to assess the outcomes in high risk surgical patients. Thus, the purposes of this study were to evaluate whether perioperative use of point-of-care ultrasound can reduce the worse postoperative outcomes in high surgical patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Point-of-care ultrasound is increasingly established as a useful bedside tool when performed by the anesthesiologist for evaluation of cardiopulmonary dysfunction and other emergent situations. However, it remains unclear whether use of perioperative point-of-care ultrasound can reduce the worse postoperative outcomes in high surgical risk patients.

Patients were randomly allocated to two groups. In the point-of-care ultrasound group, treatment was oriented by the findings of point-of-care ultrasound, while in the control group the decisions about the management of patients were made by the experience of the clinical team. The primary outcome measures were hospital mortality and 28-day mortality, and the secondary outcome measures were the complications and length of hospital stay.

Study Type

Observational

Enrollment (Anticipated)

200

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

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Zhongda Hospital

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

More and more high risk patients undergo surgery,which is associated with increased morbidity and mortality. The aim of the present study was to investigate the value of point-of-care ultrasound for assessment of postoperative outcomes in high risk surgical patients.

Description

Inclusion Criteria:

  • Patients who have comprised cardiovascular，respiratory diseases，or other critical illness.

Exclusion Criteria:

  • Patients who decline to participate.

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
Intervention / Treatment
Point-of-care ultrasound group
High risk patients received point-of-care ultrasound assessment perioperatively, treatment was oriented by the findings of point-of-care ultrasound.
Device: Point-of-care Ultrasound
Patients' management in the point-of-care ultrasound group will be adjusted according to the results of ultrasound, whereas patients in the control group the decisions about the management were made by the experience of clinical team.
Control group
High risk patients received management by the experience of the clinical team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypotension
Time Frame: Within 7 days after surgery
Patients who have hypotension which is defined by mean arterial pressure less than 60 mmHg
Within 7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongda Hospital

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)

February 1, 2017

Primary Completion (ANTICIPATED)

May 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

April 17, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (ACTUAL)

April 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20161226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Ultrasonography

Clinical Trials on Point-of-care Ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe