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

Emergency Surgery Clinical Trial

Official title:

Preoperative Rapid Pou Ultrasound（Pre-operative Ultrasound Evaluation Protocol） Assessment of Randomized Controlled Clinical Trials for Optimal Management of Anesthesia in Critically Ill Patients Undergoing Emergency Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04111783
• Other study ID #: daizhongliang-03
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: September 2019
• Source: Shenzhen People's Hospital
• Contact: ping wang, MD
• Phone: 13530756996
• Email: pwang2011[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2021
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Emergency Surgery

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Shenzhen People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe complication rate	Serious complications include cardiac arrest, respiratory failure, hemorrhagic shock, pulmonary embolism, etc.	The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years
Primary	mortality rate	The number of patients who died from any cause since the date of randomization.	The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years
Primary	Subjects' health status scores 30 days, 90 days, half a year, and one year after surgery.	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.	The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years