Mechanical Ventilation in Surgical Patients

Not yet recruiting

• Conditions: Surgery; Ventilator Lung; Postoperative Complications
• Interventions: Other: Intraoperative mechanical ventilation for surgery

• Registration Number: NCT06296277
• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

Brief Summary

This is an investigator-initiated, international, multicenter, prospective, cross-sectional study that aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation.

Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded

Detailed Description

This is an investigator-initiated, international, multicenter, prospective, cross-sectional study The here proposed study aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation.

Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded.

The primary endpoint is to report the number of patients with PPCs occurring in the first 5 postoperative days. As secondary endpoint, the practice of mechanical ventilation in patients undergoing general anesthesia for surgery will be ascertained including key intraoperative ventilator characteristics and respiratory system mechanics. Other secondary endpoints will include: incidence and type of IAEs; postoperative complications other than PPCs in the first 5 postoperative days; intensive care unit (ICU) admission and length of stay, hospital length of stay, and hospital mortality on day 28.

Participating hospitals have the flexibility to choose a specific time period for data collection, but it is imperative that this process occurs within 8 weeks from receiving approval by the local Ethics Committee. Furthermore, each participating center will conduct data collection during a predetermined 7-day period. Local investigators will capture data in an electronic case recording form, including patient demographics and baseline characteristics, intraoperative ventilator settings and ventilation parameters, and outcomes.

Study Timeline

• Study First Submitted: 2024-02-29
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-06
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Study Start: 2024-06-01
• Primary Completion: 2024-10-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Adults; and
• Receiving intraoperative IMV (via tracheal intubation, or supraglottic device ) during general anesthesia for surgery

Exclusion Criteria

• Receiving intraoperative IMV outside of an operating room; and
• Receiving intraoperative IMV during extracorporeal life support

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intraoperative mechanical ventilation	Intraoperative mechanical ventilation for surgery	Patients subjected to invasive mechanical ventilation (IMV) during general anesthesia for surgery

Primary Outcome Measures

Name	Time	Method
Postoperative pulmonary complications (PPCs)	within 5 days after surgery	Incidence and type of PPCs

Secondary Outcome Measures

Name	Time	Method
Intraoperative mechanical ventilation practice	Intraoperatively	Mechanical ventilation settings in patients undergoing general anesthesia for surgery
Postoperative clinical outcome	Postoperatively, on day 28 following surgery	Hospital mortality
Intraoperative adverse events (IAEs)	Intraoperatively	Incidence and type of IAEs