Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Complications
- Sponsor
- Università degli Studi di Ferrara
- Enrollment
- 1536
- Primary Endpoint
- Postoperative pulmonary complications
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief 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 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.
Investigators
Savino Spadaro
Principal investigator
Università degli Studi di Ferrara
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Need for intubation or non-invasive ventilation(First 7 days after surgery)
- Need for Intensive Care admission(From hospital entrance to hospital discharge, assessed up to 30 days)
- Postoperative Oxygenation(Within 2 hours after surgery)
- Days of hospitalization(From hospital entrance to hospital discharge, assessed up to 30 days)
- Length of stay in ICU(From intensive care entrance to intensive care discharge, assessed up to 30 days)