Mechanical Ventilation Complication, Postoperative Complications
Conditions
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.
Interventions
PROCEDUREMechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow Limitation
Positive End expiratory pressure will be set according to the positive end-expiratory pressure able to revert the expiratory flow limitation.
PROCEDUREMechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow Limitation
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.
Sponsors
Università degli Studi di Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pulmonary complications | First 7 days after surgery | The investigators will evaluate the number of Pulmonary postoperative complications in the first 7 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Oxygenation | Within 2 hours after surgery | The investigators will evaluate postoperative oxygenation after surgery |
| Need for intubation or non-invasive ventilation | First 7 days after surgery | The investigators will evaluate the need for intubation or non-invasive ventilation |
| Days of hospitalization | From hospital entrance to hospital discharge, assessed up to 30 days | The investigators will evaluate the number of days of hospital stay |
| Need for Intensive Care admission | From hospital entrance to hospital discharge, assessed up to 30 days | The investigators will evaluate the need for Intensive Care admission |
| Length of stay in ICU | From intensive care entrance to intensive care discharge, assessed up to 30 days | The investigators will evaluate the length of Intensive care unit stay |
Contacts
Primary ContactSavino Spadaro, PhD
Outcome results
None listed