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

NCT04111783 | Unknown

• 1 other identifier: daizhongliang-03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergency Surgery

Keywords

anesthesia; Preoperative rapid POU ultrasound; clinical trials

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

POU ultrasound intervention test group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

POU protocol ultrasound 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.

POU ultrasound intervention test group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518001, China

RECRUITING

Study Officials

• ping wang, MD

  China, Guangdong ,Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ping wang, MD

CONTACT

13530756996; pwang2011@163.com

zhongliang dai, MD

CONTACT

13530756996; daizhongliang@jnu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Volunteers and data collectors was masked
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 1, 2019
• Study Start: March 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: February 28, 2021
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)