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

Primary Purpose

Emergency Surgery

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

POU protocol ultrasound

About this trial

This is an interventional diagnostic trial for Emergency Surgery focused on measuring anesthesia, Preoperative rapid POU ultrasound, clinical trials

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shenzhen People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

POU ultrasound intervention test group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Severe complication rate

Serious complications include cardiac arrest, respiratory failure, hemorrhagic shock, pulmonary embolism, etc.

mortality rate

The number of patients who died from any cause since the date of randomization.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04111783

First Posted

September 25, 2019

Last Updated

September 30, 2019

Sponsor

Shenzhen People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04111783

Brief Title

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

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

February 29, 2020 (Anticipated)

Study Completion Date

February 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenzhen People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Emergency Surgery

Keywords

anesthesia, Preoperative rapid POU ultrasound, clinical trials

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Volunteers and data collectors was masked

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

POU ultrasound intervention test group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

POU protocol ultrasound

Intervention Description

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.

Primary Outcome Measure Information:

Title

Severe complication rate

Description

Serious complications include cardiac arrest, respiratory failure, hemorrhagic shock, pulmonary embolism, etc.

Time Frame

The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years

Title

mortality rate

Description

The number of patients who died from any cause since the date of randomization.

Time Frame

The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years

Title

Subjects' health status scores 30 days, 90 days, half a year, and one year after surgery.

Description

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.

Time Frame

The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ping wang, MD

Phone

13530756996

pwang2011@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

zhongliang dai, MD

Phone

13530756996

daizhongliang@jnu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ping wang, MD

Organizational Affiliation

China, Guangdong ,Shenzhen People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shenzhen People's Hospital

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518001

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ping wang, MD

Phone

13530756996

pwang2011@163.com

First Name & Middle Initial & Last Name & Degree

zhongliang dai, MD

Phone

13530756996

daizhongliang@jnu.edu.cn

First Name & Middle Initial & Last Name & Degree

ping wang, MD

12. IPD Sharing Statement

Plan to Share IPD

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

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