Preoperative Rapid Pou Ultrasound Assessment in Critically Ill Patients Undergoing Emergency Surgery

NCT ID: NCT04111783

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-02-28

Brief Summary

With the development of society, the number of emergency critical operations is increasing year by year. Traditionally, the patient's systemic and circulatory status is indirectly assessed by testing and blood pressure heart rate. There are cases where the diagnosis is imperfect and the results are unreliable. Preoperative POU rapid ultrasound is a preoperative bedside ultrasound evaluation method first proposed by the Anesthesiology Department of Huaxi Hospital (three engineering units). This project will cooperate with Huaxi Hospital to explore whether the effect of intraoperative anesthesia management under POU guidance is better than traditional anesthesia management. This study will provide a new preoperative evaluation anesthesia management program for emergency critically ill patients with important clinical and social significance.

Detailed Description

According to the inclusion and exclusion criteria, the patients will be randomly divided into two groups：In the control group, the anesthesiologist performed according to the existing preoperative evaluation program and existing experience, and guided the anesthesia management with the evaluation results.The experimental group used POU protocol ultrasound to perform a heart scan and a standard scan, a large vascular scan under the xiphoid, a body cavity scan, a standard section, and a lung scan in 10 minutes. Comprehensive preoperative circulation and assessment of systemic conditions, and guided intraoperative anesthesia management with assessment results.

Conditions

Emergency Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

POU ultrasound intervention test group

The experimental group used POU protocol ultrasound to perform a heart scan and a standard scan, a large vascular scan under the xiphoid, a body cavity scan, a standard section, and a lung scan in 10 minutes. Comprehensive preoperative circulation and assessment of systemic conditions, and guided intraoperative anesthesia management with assessment results.

Group Type: EXPERIMENTAL

POU protocol ultrasound

Intervention Type: DEVICE

The evaluation method performed a preoperative examination of the patient within 10 minutes by a heart scan and a standard scan of the face, a large vascular scan under the xiphoid, a body cavity scan, and a standard scan of the face and a lung scan. Preparation, providing anesthesia and surgeons with a fast, comprehensive and accurate preoperative judgment with important clinical and social significance.

Control group

the anesthesiologist performed according to the existing preoperative evaluation program and existing experience, and guided the anesthesia management with the evaluation results.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

POU protocol ultrasound

The evaluation method performed a preoperative examination of the patient within 10 minutes by a heart scan and a standard scan of the face, a large vascular scan under the xiphoid, a body cavity scan, and a standard scan of the face and a lung scan. Preparation, providing anesthesia and surgeons with a fast, comprehensive and accurate preoperative judgment with important clinical and social significance.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1.pulse oxygen saturation (spO2) ≤ 92% when inhaling air.
• 2.respiratory frequency ≥ 20 beats / min.
• 3.systolic blood pressure (sbp) <90mmHg.
• 4.heart rate (hr)>100 times/min.
• 5.requires positive inotropic drugs and/or vasopressors.
• 6.need artificial ventilation.
• 7.Signing informed consent.

Exclusion Criteria

• 1.age <14 years old.
• 2.unable to perform ultrasound evaluation (bandage, clam shell).
• 3.participated in other clinical trials in the first 3 months of the study.
• 4.researchers believe that it is not appropriate to include this tester.
• 5.any reason can not cooperate with this study.
• 6.cardiac surgery patient
• 7.organ transplant patient.
• 8.obstetric surgery patient.
• 9.you can start rescue after entering the room (such as CPR, etc.), and you are not allowed to perform ultrasound scans.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ping wang, MD

Role: PRINCIPAL_INVESTIGATOR

China, Guangdong ,Shenzhen People's Hospital

Locations

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

ping wang, MD

Role: CONTACT

pwang2011@163.com

13530756996

zhongliang dai, MD

Role: CONTACT

daizhongliang@jnu.edu.cn

13530756996

Facility Contacts

ping wang, MD

Role: primary

pwang2011@163.com

13530756996

zhongliang dai, MD

Role: backup

daizhongliang@jnu.edu.cn

13530756996

Other Identifiers

daizhongliang-03

Identifier Type: -

Identifier Source: org_study_id