UltrasonographyNCT03123536
Use of Point-of-care Ultrasound in High Risk Surgical Patients
An observational study of Ultrasonography and Outcomes, run by Zhongda Hospital at 1 site in China.
Trial summary
There is currently a lack of evidence to support the use of perioperative point-of-care ultrasound to assess the outcomes in high risk surgical patients. Thus, the purposes of this study were to evaluate whether perioperative use of point-of-care ultrasound can reduce the worse postoperative outcomes in high surgical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ultrasonography, Outcomes, Cardiopulmonary
- What is being tested?
- Point-of-care Ultrasound
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to Sep 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: More and more high risk patients undergo surgery,which is associated with increased morbidity and mortality. The aim of the present study was to investigate the value of point-of-care ultrasound for assessment of postoperative outcomes in high risk surgical patients.
Who may be able to join
- Patients who have comprised cardiovascular，respiratory diseases，or other critical illness.
Who cannot join
- Patients who decline to participate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu, 210009
Jian-jun Yang, 13357739238, yjyangjj@126.com
Mu-huo Ji, 13912975380, jimuhuo2009@sina.com
About this study
Official title: Effects of Perioperative Point-of-care Ultrasound Assessment on Postoperative Outcomes in High Risk Surgical Patients
There is currently a lack of evidence to support the use of perioperative point-of-care ultrasound to assess the outcomes in high risk surgical patients. Thus, the purposes of this study were to evaluate whether perioperative use of point-of-care ultrasound can reduce the worse postoperative outcomes in high surgical patients.
Read the detailed description
Point-of-care ultrasound is increasingly established as a useful bedside tool when performed by the anesthesiologist for evaluation of cardiopulmonary dysfunction and other emergent situations. However, it remains unclear whether use of perioperative point-of-care ultrasound can reduce the worse postoperative outcomes in high surgical risk patients.
Patients were randomly allocated to two groups. In the point-of-care ultrasound group, treatment was oriented by the findings of point-of-care ultrasound, while in the control group the decisions about the management of patients were made by the experience of the clinical team. The primary outcome measures were hospital mortality and 28-day mortality, and the secondary outcome measures were the complications and length of hospital stay.
- Conditions
- Ultrasonography, Outcomes, Cardiopulmonary
- Being tested
- Point-of-care Ultrasound
- Keywords
- high risk, complication, Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care UltrasoundDevice
Patients' management in the point-of-care ultrasound group will be adjusted according to the results of ultrasound, whereas patients in the control group the decisions about the management were made by the experience of clinical team.
| Study group | Role | What they receive |
|---|---|---|
| Point-of-care ultrasound group | High risk patients received point-of-care ultrasound assessment perioperatively, treatment was oriented by the findings of point-of-care ultrasound. Receives: Device: Point-of-care Ultrasound | |
| Control group | High risk patients received management by the experience of the clinical team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
Patients who have hypotension which is defined by mean arterial pressure less than 60 mmHg
Measured: Within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Feb 2017
- Primary completionMay 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-jun Yang, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123536
- Sponsor's protocol ID
- 20161226
- Status last verified
- Apr 2017
- First submitted
- 17 Apr 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Perioperative Point-of-care Ultrasound Assessment on Postoperative Outcomes in High Risk Surgical Patients
- ClinicalTrials.gov ID
- NCT03123536
- Acronym / sponsor ID
- 20161226
- Conditions
- Ultrasonography, Outcomes, Cardiopulmonary
- Keywords
- high risk, complication, Ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 21 Apr 2017 (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.
There is currently a lack of evidence to support the use of perioperative point-of-care ultrasound to assess the outcomes in high risk surgical patients. Thus, the purposes of this study were to evaluate whether perioperative use of point-of-care ultrasound can reduce the worse postoperative outcomes in high surgical patients.
Detailed description
Point-of-care ultrasound is increasingly established as a useful bedside tool when performed by the anesthesiologist for evaluation of cardiopulmonary dysfunction and other emergent situations. However, it remains unclear whether use of perioperative point-of-care ultrasound can reduce the worse postoperative outcomes in high surgical risk patients.
Patients were randomly allocated to two groups. In the point-of-care ultrasound group, treatment was oriented by the findings of point-of-care ultrasound, while in the control group the decisions about the management of patients were made by the experience of the clinical team. The primary outcome measures were hospital mortality and 28-day mortality, and the secondary outcome measures were the complications and length of hospital stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Point-of-care ultrasound group | – | Device: Point-of-care UltrasoundHigh risk patients received point-of-care ultrasound assessment perioperatively, treatment was oriented by the findings of point-of-care ultrasound. |
| Control group | – | –High risk patients received management by the experience of the clinical team. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- More and more high risk patients undergo surgery,which is associated with increased morbidity and mortality. The aim of the present study was to investigate the value of point-of-care ultrasound for assessment of postoperative outcomes in high risk surgical patients.
Key inclusion criteria (1 listed)
- Patients who have comprised cardiovascular，respiratory diseases，or other critical illness.
Key exclusion criteria (1 listed)
- Patients who decline to participate.
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 |
|---|---|---|
| Point-of-care UltrasoundPatients' management in the point-of-care ultrasound group will be adjusted according to the results of ultrasound, whereas patients in the control group the decisions about the management were made by the experience of clinical team. | Device | Point-of-care ultrasound group |
Primary outcome
Hypotension
Time frame: Within 7 days after surgery
Patients who have hypotension which is defined by mean arterial pressure less than 60 mmHg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasonography and Outcomes, run by Zhongda 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 1 inclusion and 1 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 21 Apr 2017. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypotension (time frame: Within 7 days after surgery). 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 21 Apr 2017.