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Individualized Intraoperative PEEP Following Alveolar Recruitment Maneuvres and Postoperative Respiratory Complications

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06600386
Enrollment
69
Registered
2024-09-19
Start date
2024-09-30
Completion date
2025-02-01
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Respiratory Complications

Keywords

Alveolar Recruitment, Laparoscopy, Indvidualized PEEP

Brief 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. 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.

Interventions

OTHERAlveolar recruitement

PEEP after alveolar reruitment maneuvres

PEEP 5 cmH2O

Sponsors

Ioanna Pikasi
CollaboratorUNKNOWN
Asklepieion Voulas General Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

ASA I-III Laparoscopic abdominal surgery

Exclusion criteria

Severe kidney dysfunction Severe hepatic dysfunction Severe respiratory disease Severe cardiac disease Severe neuromuscular disease BMI>30 Severe intraoperative hemorrage Severe intraoperative hemodynamic instability

Design outcomes

Primary

MeasureTime frameDescription
Respiratory complications30 daysPostoperative complications (atelectasis, bronchospasm, pneumonia, respiratory failure, ARDS, prolonged mechanical ventilations, reintubation, pleural infusion, COPD exacerbation)

Secondary

MeasureTime frameDescription
SpO2intraoperatively
PCO2intraoperatively
PaO2/FiO2intraoperatively
Cdynintraoperatively
Pplatintraoperatively
MAPintraoperatively
heart rateintraoperatively
LUS scorePreoperatively and 30 minutes postoperativelyUltrasonographic findigs
Ppeakintraoperatively

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026