Mechanical Ventilation ComplicationNCT05886387
a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
An observational study of Mechanical Ventilation Complication and Surgery, run by Instituto de Investigacion Sanitaria La Fe at 4 sites in 4 countries.
Trial summary
The investigators designed a protocol for a Bayesian unplanned posthoc analysis using the pooled dataset from three large randomized clinical trials. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Surgery, Pulmonary Complication
- What is being tested?
- High PEEP + Recruitment maneuvers and Standard PEEP. Low positive end-expriatory pressure
- How many people
- 3,836 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 22 Sep 2022to 25 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing mechanical ventilation for general anesthesia for surgery.
Who may be able to join
- Planned for major surgery
- At risk for pulmonary complications
Who cannot join
- Planned thoracic surgery .
- Unscheduled surgery (i.e., urgent, or emergent surgeries)
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Netherlands1 site
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam
About this study
Official title: Effect of Intraoperative PEEP With Recruitment Manoeuvres on the Occurrence of Postoperative Pulmonary Complications During General Anaesthesia--a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
The investigators designed a protocol for a Bayesian unplanned posthoc analysis using the pooled dataset from three large randomized clinical trials. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators will carry out a reanalysis of the harmonised database using Bayesian statistics.
Read the detailed description
Background: Using the frequentist approach, a recent meta-analysis of three randomized clinical trials in patients undergoing intraoperative ventilation during general anesthesia for major surgery. failed to show the benefit of ventilation that uses high positive end expiratory pressure with recruitment maneuvers when compared to ventilation that uses low positive end-expiratory pressure without recruitment maneuvers.
Methods: The investigators designed a protocol for a Bayesian analysis using the pooled dataset. The multilevel Bayesian logistic model will use the individual patient data. Prior distributions will be prespecified to represent a varying level of skepticism for the effect estimate. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators preset a range of practical equivalence to assess the futility of the intervention with an interval of odds ratio (OR) between 0.9 and 1.1 and assess how much of the 95% of highest density interval (HDI) falls between the region of practical equivalence.
- Conditions
- Mechanical Ventilation Complication, Surgery, Pulmonary Complication, Postoperative Complications
- Being tested
- High PEEP + Recruitment maneuvers, Standard PEEP. Low positive end-expriatory pressure
- Keywords
- Mechanical ventilation,, Bayesian analysis, PEEP, Recruitment Maneuvers, Intraoperative Mechanical Ventilation, Postoperative complications, Perioperative medicine
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High PEEP + Recruitment maneuversOther
The use of a High PEEP (positive end-expiratory pressure) level after recruiting collapsed alveoli can protect from mechanical ventilation associated lung injury
Standard PEEP. Low positive end-expriatory pressureOther
Mechanical ventilation is managed with a low standard PEEP without recruitment manneuvers
| Study group | Role | What they receive |
|---|---|---|
| High PEEP + Recruitment Maneuvers | Patients who received intraoperatively high PEEP (10-12 cmH2O) after a recruitment maneuvers as per the original study protocol Receives: Other: High PEEP + Recruitment maneuvers | |
| Standard PEEP | Patients who received intraoperatively standard PEEP (0-5 cmH2O) without recruitment maneuvers Receives: Other: Standard PEEP. Low positive end-expriatory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative pulmonary complications
Measured: Until day seven or hospital discharge, whichever comes first ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start22 Sep 2022
- Primary completion10 Dec 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- 3,836 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Hospital Israelita Albert Einstein, University Hospital Carl Gustav Carus, Hospital Clínico Universitario de Valencia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886387
- Sponsor's protocol ID
- Bayes_Repeat
- Status last verified
- Oct 2024
- First submitted
- 23 May 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative PEEP With Recruitment Manoeuvres on the Occurrence of Postoperative Pulmonary Complications During General Anaesthesia--a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
- ClinicalTrials.gov ID
- NCT05886387
- Acronym / sponsor ID
- Bayes_Repeat
- Conditions
- Mechanical Ventilation Complication, Surgery, Pulmonary Complication, Postoperative Complications
- Keywords
- Mechanical ventilation,, Bayesian analysis, PEEP, Recruitment Maneuvers, Intraoperative Mechanical Ventilation, Postoperative complications, Perioperative medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,836 participants (actual)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Hospital Israelita Albert Einstein, University Hospital Carl Gustav Carus, Hospital Clínico Universitario de Valencia
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 2 Jun 2023 (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.
The investigators designed a protocol for a Bayesian unplanned posthoc analysis using the pooled dataset from three large randomized clinical trials. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators will carry out a reanalysis of the harmonised database using Bayesian statistics.
Detailed description
Background: Using the frequentist approach, a recent meta-analysis of three randomized clinical trials in patients undergoing intraoperative ventilation during general anesthesia for major surgery. failed to show the benefit of ventilation that uses high positive end expiratory pressure with recruitment maneuvers when compared to ventilation that uses low positive end-expiratory pressure without recruitment maneuvers.
Methods: The investigators designed a protocol for a Bayesian analysis using the pooled dataset. The multilevel Bayesian logistic model will use the individual patient data. Prior distributions will be prespecified to represent a varying level of skepticism for the effect estimate. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators preset a range of practical equivalence to assess the futility of the intervention with an interval of odds ratio (OR) between 0.9 and 1.1 and assess how much of the 95% of highest density interval (HDI) falls between the region of practical equivalence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High PEEP + Recruitment Maneuvers | – | Other: High PEEP + Recruitment maneuversPatients who received intraoperatively high PEEP (10-12 cmH2O) after a recruitment maneuvers as per the original study protocol |
| Standard PEEP | – | Other: Standard PEEP. Low positive end-expriatory pressurePatients who received intraoperatively standard PEEP (0-5 cmH2O) without recruitment maneuvers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing mechanical ventilation for general anesthesia for surgery.
Key inclusion criteria (2 listed)
- Planned for major surgery
- At risk for pulmonary complications
Key exclusion criteria (2 listed)
- Planned thoracic surgery .
- Unscheduled surgery (i.e., urgent, or emergent surgeries)
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 |
|---|---|---|
| High PEEP + Recruitment maneuversThe use of a High PEEP (positive end-expiratory pressure) level after recruiting collapsed alveoli can protect from mechanical ventilation associated lung injury | Other | High PEEP + Recruitment Maneuvers |
| Standard PEEP. Low positive end-expriatory pressureMechanical ventilation is managed with a low standard PEEP without recruitment manneuvers | Other | Standard PEEP |
Primary outcome
Incidence of postoperative pulmonary complications
Time frame: Until day seven or hospital discharge, whichever comes first ]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Association between ventilation parameter and postoperative complicationsLink provided by the sponsor.
- PROBESE StudyLink provided by the sponsor.
- iPRVE studyLink provided by the sponsor.
- PROVHILO studyLink provided by the sponsor.
- The Association of Intraoperative driving pressure with postoperative pulmonary complications in open versus closed abdominal surgery patientsLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication and Surgery, run by Instituto de Investigacion Sanitaria La Fe at 4 sites in 4 countries.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil, Italy, Netherlands, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative pulmonary complications (time frame: Until day seven or hospital discharge, whichever comes 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 9 Oct 2024.