NCT03123536

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

April 17, 2017

Last Update Submit

April 20, 2017

Conditions

UltrasonographyOutcomesCardiopulmonary

Keywords

high riskcomplicationUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Hypotension

    Patients who have hypotension which is defined by mean arterial pressure less than 60 mmHg

    Within 7 days after surgery

Study Arms (2)

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

Control group

High risk patients received management by the experience of the clinical team.

Interventions

Point-of-care UltrasoundDEVICE

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.

Point-of-care ultrasound group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Patients who decline to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Anesthesiology

Study Record Dates

First Submitted

April 17, 2017

First Posted

April 21, 2017

Study Start

February 1, 2017

Primary Completion

May 1, 2018

Study Completion

September 1, 2018

Last Updated

April 21, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)