Clinical trial NCT04111783: Preoperative Rapid Pou Ultrasound Assessment in Critically Ill Patients Undergoing Emergency Surgery
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emergency Surgery
Keywords: anesthesia
Preoperative rapid POU ultrasound
clinical trials
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Severe complication rate
timeFrame: The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years
measure: mortality rate
timeFrame: The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years
measure: Subjects' health status scores 30 days, 90 days, half a year, and one year after surgery.
timeFrame: The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
Study officials:
affiliation: China, Guangdong ,Shenzhen People's Hospital
name: ping wang, MD
role: PRINCIPAL_INVESTIGATOR
References: