Emergency SurgeryNCT04111783
Preoperative Rapid Pou Ultrasound Assessment in Critically Ill Patients Undergoing Emergency Surgery
A study testing POU protocol ultrasound in people with Emergency Surgery, run by Shenzhen People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Emergency Surgery
- What is being tested?
- POU protocol ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518001
ping wang, MD, 13530756996, pwang2011@163.com
zhongliang dai, MD, 13530756996, daizhongliang@jnu.edu.cn
About this study
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.
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.
Read the 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.
- Conditions
- Emergency Surgery
- Being tested
- POU protocol ultrasound
- Keywords
- anesthesia, Preoperative rapid POU ultrasound, clinical trials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POU protocol ultrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe complication rate
Serious complications include cardiac arrest, respiratory failure, hemorrhagic shock, pulmonary embolism, etc.
Measured: 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.
Measured: 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.
Measured: The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Mar 2019
- Primary completion29 Feb 2020 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ping wang, MD, Principal investigator, China, Guangdong ,Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111783
- Sponsor's protocol ID
- daizhongliang-03
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04111783
- Acronym / sponsor ID
- daizhongliang-03
- Conditions
- Emergency Surgery
- Keywords
- anesthesia, Preoperative rapid POU ultrasound, clinical trials
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 29 Feb 2020 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POU ultrasound intervention test group | Experimental | Device: POU protocol ultrasoundThe 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. |
| 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POU protocol ultrasoundThe 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. | Device | POU ultrasound intervention test group |
Primary outcome
Severe complication rate
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
Serious complications include cardiac arrest, respiratory failure, hemorrhagic shock, pulmonary embolism, etc.
mortality rate
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
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.
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ping wang, MD principal investigator
China, Guangdong ,Shenzhen People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POU protocol ultrasound in people with Emergency Surgery, run by Shenzhen People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ping wang, MD (13530756996, pwang2011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe complication rate (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.