Individualized Selection of PEEP in Patients Affected by Expiratory Flow Limitation (PEEP-EFL)

Università degli Studi di Ferrara

Status: Not yet enrolling

Conditions: Postoperative Complications; Mechanical Ventilation Complication

Treatments: Procedure: Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow Limitation; Procedure: Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow Limitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06215001

PEEP-EFL

Details and patient eligibility

About

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.

Enrollment: 1,536 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,536 participants in 3 patient groups

EFL Positive - intervention

Experimental group

Description:

Patients with Expiratory flow limitation will undergo a positive end-expiratory pressure trial to assess the level of positive end-expiratory pressure that eliminates the Expiratory Flow limitation. Positive end-expiratory pressure will be therefore set according to this value.

Treatment:

Procedure: Mechanical ventilation setting (Positive end-expiratory pressure) according to Expiratory Flow Limitation

EFL Positive - control group

Active Comparator group

Description:

Patients with Expiratory flow limitation will undergo a positive end-expiratory pressure trial to assess the level of positive end-expiratory pressure that eliminates the Expiratory Flow limitation. Positive end-expiratory pressure will be set at a fixed level of 4 cmH2O.

Treatment:

Procedure: Mechanical ventilation setting (Positive end-expiratory pressure) not according to Expiratory Flow Limitation

EFL negative patients

No Intervention group

Description:

Patients with negative positive end-expiratory pressure test (no expiratory flow limitation) will be treated according to the current evidence and followed up for 7 days after surgery to evaluate the incidence of pulmonary postoperative complications.