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

Not Applicable

• Conditions: Emergency Surgery
• Interventions: Device: POU protocol ultrasound

• Registration Number: NCT04111783
• Lead Sponsor: Shenzhen People's Hospital

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.

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2019-09
• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-30
• Last Update Submitted: 2019-09-30
• Study First Posted: 2019-10-01
• Last Update Posted: 2019-10-01
• Primary Completion: 2020-02-29
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POU ultrasound intervention test group	POU protocol ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Severe complication rate	The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years	Serious complications include cardiac arrest, respiratory failure, hemorrhagic shock, pulmonary embolism, etc.
Subjects' health status scores 30 days, 90 days, half a year, and one year after surgery.	The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years	Follow-up was performed 30 days, 90 days, half a year, and one year after surgery, and the patient's prognosis was assessed using a health score sheet.
mortality rate	The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years	The number of patients who died from any cause since the date of randomization.

Trial Locations

Locations (1)

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China