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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Emergency Surgery
• Intervention / Treatment: Device: POU protocol ultrasound

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ping wang, MD; Phone Number: 13530756996; Email: pwang2011@163.com
• Study Contact Backup: Name: zhongliang dai, MD; Phone Number: 13530756996; Email: daizhongliang@jnu.edu.cn

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518001
      • Recruiting
      • ShenZhen People's Hospital
      • Contact: ping wang, MD; Phone Number: 13530756996; Email: pwang2011@163.com
      • Contact: zhongliang dai, MD; Phone Number: 13530756996; Email: daizhongliang@jnu.edu.cn
      • Principal Investigator: ping wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Control group; the anesthesiologist performed according to the existing preoperative evaluation program and existing experience, and guided the anesthesia management with the evaluation results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital
• Investigators: Principal Investigator: ping wang, MD, China, Guangdong ,Shenzhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): February 29, 2020
• Study Completion (Anticipated): February 28, 2021

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: anesthesia; clinical trials; Preoperative rapid POU ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: daizhongliang-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No