Assessing PEEP effects on obese patients during laparoscopic surgery
Recruitment-to-inflation Ratio to Set Positive End-expiratory Pressure for Laparoscopic/Robotic Surgery: a Multicenter Study
Azienda Ospedaliera di Perugia · NCT05702554
This study is testing how different levels of breathing support can help obese patients breathe better during laparoscopic surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera di Perugia (other) |
| Locations | 2 sites (Perugia, Umbria, Italy and 1 other locations) |
| Trial ID | NCT05702554 on ClinicalTrials.gov |
What this trial studies
This investigation evaluates the impact of positive end-expiratory pressure (PEEP) on respiratory system compliance in obese patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum. Adult patients with a body mass index of 30 kg/m2 or higher will be enrolled after providing informed consent. The study will involve the application of different PEEP levels based on the recruitment-to-inflation ratio to optimize respiratory mechanics during surgery. Exclusion criteria include severe comorbidities that may affect respiratory function.
Who should consider this trial
Good fit: Ideal candidates are adult obese patients with a BMI of 30 kg/m2 or higher scheduled for laparoscopic or robotic surgery requiring invasive mechanical ventilation.
Not a fit: Patients with severe comorbidities such as ASA score ≥ 4 or chronic respiratory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve respiratory management and outcomes for obese patients undergoing laparoscopic surgery.
How similar studies have performed: While similar approaches have been explored, this specific methodology focusing on PEEP adjustment in obese patients during laparoscopic surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult obese (body mass index ≥ 30 kg/m2) patients undergoing invasive mechanical ventilation for laparoscopic or robotic surgery with pneumoperitoneum will be enrolled, upon the acquisition of informed consent. Exclusion Criteria: * Will be excluded all the patients with the following conditions: american society of anesthesiologists (ASA) score ≥ 4; severe cardiopathy, intracranial hypertension, tracheosthomy, previous cardio-thoracic surgery, pulmonary hypertrension, broncho-pleural fistula, pulmonary emphysema, pnumothorax, chronic respiratory failure, chronic obstructive pulmonary disease, pregnancy.
Where this trial is running
Perugia, Umbria, Italy and 1 other locations
- Università degli Studi di Perugia — Perugia, Umbria, Italy, Italy (RECRUITING)
- Università degli Studi di Perugia — Perugia, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Respiratory System Mechanics, Pneumoperitoneum