Postoperative Respiratory ComplicationsPhase 2NCT06600386
Individualized Intraoperative PEEP Following Alveolar Recruitment Maneuvres and Postoperative Respiratory Complications
A Phase 2 study testing Alveolar recruitement and Standard PEEP in people with Postoperative Respiratory Complications, run by Asklepieion Voulas General Hospital at 1 site in Greece.
Trial summary
Patients ASA I-III, undergoing laparoscopic abdominal surgery will be randomly assigned, into one of two groups, namely group C-PEEP , that will be the control group ; and group I-PEEP, where alveolar recruitment maneuvres will take place in order to identify each patient\'s individualized optimal PEEP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Respiratory Complications
- What is being tested?
- Alveolar recruitement and Standard PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteGreece
- Study dates
- 30 Sep 2024to 1 Feb 2025
- Phase
- Phase 2
- 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
- ASA I-III Laparoscopic abdominal surgery
Who cannot join
- Severe kidney dysfunction Severe hepatic dysfunction Severe respiratory disease Severe cardiac disease Severe neuromuscular disease BMI\>30 Severe intraoperative hemorrage Severe intraoperative hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Individualized Intraoperative PEEP After Alveolar Recruitment Maneuvres on the Incidence of Postoperative Respiratory Complications Following Laparoscopic Abdominal Surgery. A Prospective Randomized Controlled Study
Patients ASA I-III, undergoing laparoscopic abdominal surgery will be randomly assigned, into one of two groups, namely group C-PEEP , that will be the control group ; and group I-PEEP, where alveolar recruitment maneuvres will take place in order to identify each patient\'s individualized optimal PEEP. All patients will receive a standardized anesthesia regimen. The lung ultrasound score will be evaluated in all patients in the PACU and then respiratory complications will be recorded on the 24th hour, 48th hour, 7th day and 30the day, postoperatively.
- Conditions
- Postoperative Respiratory Complications
- Being tested
- Alveolar recruitement, Standard PEEP
- Keywords
- Alveolar Recruitment, Laparoscopy, Indvidualized PEEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar recruitementOther
PEEP after alveolar reruitment maneuvres
Standard PEEPOther
PEEP 5 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| C-PEEP | Active comparator | PEEP is standard (5cmH2O) Receives: Other: Standard PEEP |
| I-PEEP | Active comparator | PEEP is individualized following standard recruitment maneuvres Receives: Other: Alveolar recruitement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory complications
Postoperative complications (atelectasis, bronchospasm, pneumonia, respiratory failure, ARDS, prolonged mechanical ventilations, reintubation, pleural infusion, COPD exacerbation)
Measured: 30 days
Secondary outcomes (9)
Pplat
Measured: intraoperatively
SpO2
Measured: intraoperatively
PCO2
Measured: intraoperatively
PaO2/FiO2
Measured: intraoperatively
Cdyn
Measured: intraoperatively
Ppeak
Measured: intraoperatively
MAP
Measured: intraoperatively
heart rate
Measured: intraoperatively
LUS score
Ultrasonographic findigs
Measured: Preoperatively and 30 minutes postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Respiratory 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepieion Voulas General Hospital
- Sponsor type
- Other government
- Collaborators
- Ioanna Pikasi
- Responsible party
- Principal investigator, Alexandros Makris, Asklepieion Voulas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600386
- Sponsor's protocol ID
- 10542/22-05-2024/AP51
- Status last verified
- Feb 2025
- First submitted
- 14 Sep 2024
- Last updated
- 19 Feb 2025
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Individualized Intraoperative PEEP After Alveolar Recruitment Maneuvres on the Incidence of Postoperative Respiratory Complications Following Laparoscopic Abdominal Surgery. A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06600386
- Acronym / sponsor ID
- 10542/22-05-2024/AP51
- Conditions
- Postoperative Respiratory Complications
- Keywords
- Alveolar Recruitment, Laparoscopy, Indvidualized PEEP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Asklepieion Voulas General HospitalOther government
- Collaborators
- Ioanna Pikasi
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 19 Sep 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.
Patients ASA I-III, undergoing laparoscopic abdominal surgery will be randomly assigned, into one of two groups, namely group C-PEEP , that will be the control group ; and group I-PEEP, where alveolar recruitment maneuvres will take place in order to identify each patient\'s individualized optimal PEEP. All patients will receive a standardized anesthesia regimen. The lung ultrasound score will be evaluated in all patients in the PACU and then respiratory complications will be recorded on the 24th hour, 48th hour, 7th day and 30the day, postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-PEEP | Active comparator | Other: Standard PEEPPEEP is standard (5cmH2O) |
| I-PEEP | Active comparator | Other: Alveolar recruitementPEEP is individualized following standard recruitment maneuvres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-III Laparoscopic abdominal surgery
Key exclusion criteria (1 listed)
- Severe kidney dysfunction Severe hepatic dysfunction Severe respiratory disease Severe cardiac disease Severe neuromuscular disease BMI\>30 Severe intraoperative hemorrage Severe intraoperative hemodynamic instability
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 |
|---|---|---|
| Alveolar recruitementPEEP after alveolar reruitment maneuvres | Other | I-PEEP |
| Standard PEEPPEEP 5 cmH2O | Other | C-PEEP |
Primary outcome
Respiratory complications
Time frame: 30 days
Postoperative complications (atelectasis, bronchospasm, pneumonia, respiratory failure, ARDS, prolonged mechanical ventilations, reintubation, pleural infusion, COPD exacerbation)
9 secondary outcomes
Pplat
Time frame: intraoperatively
SpO2
Time frame: intraoperatively
PCO2
Time frame: intraoperatively
PaO2/FiO2
Time frame: intraoperatively
Cdyn
Time frame: intraoperatively
Ppeak
Time frame: intraoperatively
MAP
Time frame: intraoperatively
heart rate
Time frame: intraoperatively
LUS score
Time frame: Preoperatively and 30 minutes postoperatively
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 19 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alveolar recruitement and Standard PEEP in people with Postoperative Respiratory Complications, run by Asklepieion Voulas General Hospital at 1 site in Greece.
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: finished, as of the sponsor's last update on 19 Feb 2025. 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 Greece. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Respiratory complications (time frame: 30 days). 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 19 Feb 2025.