Postoperative ComplicationsPEEP-EFLNCT06215001
Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation
A study testing Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow Limitation and Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow Limitation in people with Postoperative Complications and Mechanical Ventilation Complication, run by Università degli Studi di Ferrara.
Trial summary
The goal of this clinical trial is to compare different mechanical ventilation settings in Patients undergoing laparoscopic surgery and affected by Expiratory flow limitation. The main question[s] it aims to answer are: If individualizing mechanical ventilation on expiratory flow limitation can reduce pulmonary… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Complications, Mechanical Ventilation Complication
- What is being tested?
- Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow Limitation and Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow Limitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,536 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Mar 2025
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18 and 90 years old;
- Patients undergoing laparoscopic, robotic surgery
- Surgery performed in elective regimen;
- Length of mechanical ventilation more than 120 minutes;
- Presence of invasive pressure monitoring for clinical purposes;
Who cannot join
- Age < 18 or > 90;
- Severe chronic obstructive pulmonary disease with GOLD stage 3 or 4;
- Length of mechanical ventilation less than 120 minutes;
- Unplanned conversion to laparotomy surgery;
- Refusal to participate by the patient;
- Anesthesia maintenance using Desflurane.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation: a Randomized Controlled Trial
The goal of this clinical trial is to compare different mechanical ventilation settings in Patients undergoing laparoscopic surgery and affected by Expiratory flow limitation. The main question[s] it aims to answer are:
- If individualizing mechanical ventilation on expiratory flow limitation can reduce pulmonary postoperative complications;
- If patients with expiratory flow limitation have a higher incidence of pulmonary postoperative complications as compared to patients with no expiratory flow limitation;
Read more
Participants will be screened for expiratory fow limitation and patients with positive screening will be randomized into two groups. Each group will receive a different intraoperative mechanical ventilation:
- Personalized positive end-expiratory pressure based on EFL
- Standard of care positive end-expiratory pressure
Researchers will then compare the two groups to see if the incidence of pulmonary postoperative complications in the first 7 days after surgery is different.
- Being tested
- Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow Limitation, Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow Limitation
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow LimitationProcedure or surgery
Positive End expiratory pressure will be set according to the positive end-expiratory pressure able to revert the expiratory flow limitation.
Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow LimitationProcedure or surgery
Positive End expiratory pressure will be set not according to the positive end-expiratory pressure able to revert the expiratory flow limitation but to a standard level of 4 cmH2O.
| Study group | Role | What they receive |
|---|---|---|
| EFL Positive - intervention | Experimental | Patients with Expiratory flow limitation will undergo a positive end-expiratory pressure trial to assess the level of positive end-expiratory pressure that eliminates the Expiratory Flow limitation. Positive end-expiratory pressure will be therefore set according to this value. Receives: Procedure: Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow Limitation |
| EFL Positive - control group | Active comparator | Patients with Expiratory flow limitation will undergo a positive end-expiratory pressure trial to assess the level of positive end-expiratory pressure that eliminates the Expiratory Flow limitation. Positive end-expiratory pressure will be set at a fixed level of 4 cmH2O. Receives: Procedure: Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow Limitation |
| EFL negative patients | No intervention | Patients with negative positive end-expiratory pressure test (no expiratory flow limitation) will be treated according to the current evidence and followed up for 7 days after surgery to evaluate the incidence of pulmonary postoperative complications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complications
The investigators will evaluate the number of Pulmonary postoperative complications in the first 7 days after surgery
Measured: First 7 days after surgery
Secondary outcomes (5)
Postoperative Oxygenation
The investigators will evaluate postoperative oxygenation after surgery
Measured: Within 2 hours after surgery
Need for intubation or non-invasive ventilation
The investigators will evaluate the need for intubation or non-invasive ventilation
Measured: First 7 days after surgery
Days of hospitalization
The investigators will evaluate the number of days of hospital stay
Measured: From hospital entrance to hospital discharge, assessed up to 30 days
Need for Intensive Care admission
The investigators will evaluate the need for Intensive Care admission
Measured: From hospital entrance to hospital discharge, assessed up to 30 days
Length of stay in ICU
The investigators will evaluate the length of Intensive care unit stay
Measured: From intensive care entrance to intensive care discharge, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savino Spadaro, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215001
- Sponsor's protocol ID
- PEEP-EFL
- Acronym
- PEEP-EFL
- Status last verified
- Jan 2024
- First submitted
- 6 Nov 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06215001
- Acronym / sponsor ID
- PEEP-EFL / PEEP-EFL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,536 participants (estimated)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 22 Jan 2024 (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 goal of this clinical trial is to compare different mechanical ventilation settings in Patients undergoing laparoscopic surgery and affected by Expiratory flow limitation. The main question[s] it aims to answer are:
- If individualizing mechanical ventilation on expiratory flow limitation can reduce pulmonary postoperative complications;
- If patients with expiratory flow limitation have a higher incidence of pulmonary postoperative complications as compared to patients with no expiratory flow limitation;
Participants will be screened for expiratory fow limitation and patients with positive screening will be randomized into two groups. Each group will receive a different intraoperative mechanical ventilation:
- Personalized positive end-expiratory pressure based on EFL
- Standard of care positive end-expiratory pressure
Researchers will then compare the two groups to see if the incidence of pulmonary postoperative complications in the first 7 days after surgery is different.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EFL Positive - intervention | Experimental | Procedure: Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow LimitationPatients with Expiratory flow limitation will undergo a positive end-expiratory pressure trial to assess the level of positive end-expiratory pressure that eliminates the Expiratory Flow limitation. Positive end-expiratory pressure will be therefore set according to this value. |
| EFL Positive - control group | Active comparator | Procedure: Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow LimitationPatients with Expiratory flow limitation will undergo a positive end-expiratory pressure trial to assess the level of positive end-expiratory pressure that eliminates the Expiratory Flow limitation. Positive end-expiratory pressure will be set at a fixed level of 4 cmH2O. |
| EFL negative patients | No intervention | –Patients with negative positive end-expiratory pressure test (no expiratory flow limitation) will be treated according to the current evidence and followed up for 7 days after surgery to evaluate the incidence of pulmonary postoperative complications. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages between 18 and 90 years old;
- Patients undergoing laparoscopic, robotic surgery
- Surgery performed in elective regimen;
- Length of mechanical ventilation more than 120 minutes;
- Presence of invasive pressure monitoring for clinical purposes;
Key exclusion criteria (6 listed)
- Age < 18 or > 90;
- Severe chronic obstructive pulmonary disease with GOLD stage 3 or 4;
- Length of mechanical ventilation less than 120 minutes;
- Unplanned conversion to laparotomy surgery;
- Refusal to participate by the patient;
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 |
|---|---|---|
| Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow LimitationPositive End expiratory pressure will be set according to the positive end-expiratory pressure able to revert the expiratory flow limitation. | Procedure or surgery | EFL Positive - intervention |
| Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow LimitationPositive End expiratory pressure will be set not according to the positive end-expiratory pressure able to revert the expiratory flow limitation but to a standard level of 4 cmH2O. | Procedure or surgery | EFL Positive - control group |
Primary outcome
Postoperative pulmonary complications
Time frame: First 7 days after surgery
The investigators will evaluate the number of Pulmonary postoperative complications in the first 7 days after surgery
5 secondary outcomes
Postoperative Oxygenation
Time frame: Within 2 hours after surgery
Need for intubation or non-invasive ventilation
Time frame: First 7 days after surgery
Days of hospitalization
Time frame: From hospital entrance to hospital discharge, assessed up to 30 days
Need for Intensive Care admission
Time frame: From hospital entrance to hospital discharge, assessed up to 30 days
Length of stay in ICU
Time frame: From intensive care entrance to intensive care discharge, assessed up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow Limitation and Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow Limitation in people with Postoperative Complications and Mechanical Ventilation Complication, run by Università degli Studi di Ferrara.
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 5 inclusion and 6 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 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Savino Spadaro, PhD (0532/235605, savino.spadaro@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complications (time frame: First 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 22 Jan 2024.