Postoperative Respiratory ComplicationNCT04860648
Lung Ultrasound Guided Prevention of Postoperative Pulmonary Complications in Moderate to High Risk Patients
A study testing lung ultrasound in people with Postoperative Respiratory Complication, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Postoperative pulmonary complications (PPCs) occur in many patients, especially those with high risks, and are associated with increased hospital length of stay, morbidity and costs of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Respiratory Complication
- What is being tested?
- lung ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- 1 siteChina
- Study dates
- May 2021to Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 Estimated ARISCAT score ≥26分
Who cannot join
- transferred to ward or ICU directly day surgery (patients won't stay in hospital longer than 24 hours after surgery actual ARISCAT score < 26分 the technical incompatibility of the acoustic window patients refused pregnant
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Min Yan, Doctor, 13757118632 ext. 13252017900, zryanmin@zju.edu.cn
About this study
Official title: The Second Affiliated Hospital of Zhejiang University, School of Medicine
Postoperative pulmonary complications (PPCs) occur in many patients, especially those with high risks, and are associated with increased hospital length of stay, morbidity and costs of care. According to European Perioperative Clinical Outcome definitions, major pulmonary complications include atelectasis, respiratory infection, pleural effusion, and pneumothorax. Because identifying patients at high risk for PPCs may allow earlier treatment, predictive scores ( the Assess Respiratory Risk in Surgical Patients in Catalonia score [ARISCAT]) have been developed.Lung ultrasound (LUS) is more accurate than chest X-ray in diagnosing pulmonary complications, and lung ultrasound performed in the postanesthesia care unit may identify patients at higher risk for pulmonary complications. So we aimed to study if lung ultrasound can guide the prevention of PPCs in moderate to high risk patients.
Read the detailed description
patients recruited are randomized into the two groups: LUS group and Control group. Patients in LUS group received ultrasound examination and guided the treatment according to the ultrasound results, while the control group did not receive ultrasound examination, just the same as the routine clinical practice. This study aims to explore whether ultrasound-guided clinical treatment can reduce the incidence of postoperative pulmonary complications in moderate to highrisk patients. Before operation, informed consent was signed according to the inclusion criteria, and the incidence of pulmonary complications within 5 days after operation (or before discharge) was recorded after operation.
- Conditions
- Postoperative Respiratory Complication
- Being tested
- lung ultrasound
- Keywords
- lung ultrasound, postoperative pulmonary complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasoundOther
Also called doctors' clinical decision
doctors treat the patients combining the Lus results and clinical practice
| Study group | Role | What they receive |
|---|---|---|
| LUS group | Experimental | patients receive lung ultrasound examination, and doctors give the treatment according to the LUS results Receives: Other: lung ultrasound |
| Control group | No intervention | patients receive no lung ultrasound examination and other intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of postoperative pulmonary complications
postoperative pulmonary complications are defined as a composite outcome including respiratory infection, respiratory failure,pleural effusion, atelectasis,pneumothorax,broncospasm and aspiration pneumonitis
Measured: within 5 days after operation or before discharge, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study startMay 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Respiratory ComplicationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 592 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Yan, MD, Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860648
- Sponsor's protocol ID
- 2021-0127
- Status last verified
- Mar 2021
- First submitted
- 28 Mar 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Affiliated Hospital of Zhejiang University, School of Medicine
- ClinicalTrials.gov ID
- NCT04860648
- Acronym / sponsor ID
- 2021-0127
- Conditions
- Postoperative Respiratory Complication
- Keywords
- lung ultrasound, postoperative pulmonary complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 592 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 27 Apr 2021 (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.
Postoperative pulmonary complications (PPCs) occur in many patients, especially those with high risks, and are associated with increased hospital length of stay, morbidity and costs of care. According to European Perioperative Clinical Outcome definitions, major pulmonary complications include atelectasis, respiratory infection, pleural effusion, and pneumothorax. Because identifying patients at high risk for PPCs may allow earlier treatment, predictive scores ( the Assess Respiratory Risk in Surgical Patients in Catalonia score [ARISCAT]) have been developed.Lung ultrasound (LUS) is more accurate than chest X-ray in diagnosing pulmonary complications, and lung ultrasound performed in the postanesthesia care unit may identify patients at higher risk for pulmonary complications. So we aimed to study if lung ultrasound can guide the prevention of PPCs in moderate to high risk patients.
Detailed description
patients recruited are randomized into the two groups: LUS group and Control group. Patients in LUS group received ultrasound examination and guided the treatment according to the ultrasound results, while the control group did not receive ultrasound examination, just the same as the routine clinical practice. This study aims to explore whether ultrasound-guided clinical treatment can reduce the incidence of postoperative pulmonary complications in moderate to highrisk patients. Before operation, informed consent was signed according to the inclusion criteria, and the incidence of pulmonary complications within 5 days after operation (or before discharge) was recorded after operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUS group | Experimental | Other: lung ultrasoundpatients receive lung ultrasound examination, and doctors give the treatment according to the LUS results |
| Control group | No intervention | –patients receive no lung ultrasound examination and other intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age≥18 Estimated ARISCAT score ≥26分
Key exclusion criteria (1 listed)
- transferred to ward or ICU directly day surgery (patients won't stay in hospital longer than 24 hours after surgery actual ARISCAT score < 26分 the technical incompatibility of the acoustic window patients refused pregnant
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 |
|---|---|---|
| lung ultrasoundAlso: doctors' clinical decisiondoctors treat the patients combining the Lus results and clinical practice | Other | LUS group |
Primary outcome
the incidence of postoperative pulmonary complications
Time frame: within 5 days after operation or before discharge, whichever came first
postoperative pulmonary complications are defined as a composite outcome including respiratory infection, respiratory failure,pleural effusion, atelectasis,pneumothorax,broncospasm and aspiration pneumonitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
Related trials for Postoperative Respiratory Complication
Active, not recruiting
VentilO Prospective Study
Mechanical Ventilation Complication, Respiratory Acidosis
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
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.
Min Yan, MD study chair
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung ultrasound in people with Postoperative Respiratory Complication, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 27 Apr 2021. 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 Min Yan, MD (13757118632, zryanmin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of postoperative pulmonary complications (time frame: within 5 days after operation or before discharge, whichever came first). 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 27 Apr 2021.