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

• Sponsor: Zhongda Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03123536
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 10.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ultrasonography; Outcomes; Cardiopulmonary	Device: Point-of-care Ultrasound

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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effects of Perioperative Point-of-care Ultrasound Assessment on Postoperative Outcomes in High Risk Surgical Patients
• Actual Study Start Date: Feb 1, 2017
• Anticipated Primary Completion Date: May 1, 2018
• Anticipated Study Completion Date: Sep 1, 2018

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Hypotension [Within 7 days after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who decline to participate.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongda Hospital	Nanjing	Jiangsu	China	210009

Sponsors and Collaborators

• Zhongda Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jian-jun Yang, Director, Department of Anesthesiology, Zhongda Hospital
• ClinicalTrials.gov Identifier: NCT03123536
• Other Study ID Numbers: 20161226
• First Posted: Apr 21, 2017
• Last Update Posted: Apr 21, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jian-jun Yang, Director, Department of Anesthesiology, Zhongda Hospital: high risk; complication; Ultrasonography

Study Results

No Results Posted as of Apr 21, 2017