Mechanical Ventilation in Surgical Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-03-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Surgery Ventilator Lung Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intraoperative mechanical ventilation

Patients subjected to invasive mechanical ventilation (IMV) during general anesthesia for surgery

Intraoperative mechanical ventilation for surgery

Intervention Type OTHER

Any IMV during general anesthesia for surgery

Interventions

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Intraoperative mechanical ventilation for surgery

Any IMV during general anesthesia for surgery

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Gianmaria Cammarota

Prof Gianmaria Cammarota

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gianmaria Cammarota, Prof

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi del Piemonte Orientale

Rachele Simonte, MD

Role: STUDY_DIRECTOR

University Of Perugia

Edoardo M De Robertis, Prof

Role: STUDY_DIRECTOR

University Of Perugia

Sabrine N.T. Hemmes, MD

Role: STUDY_DIRECTOR

Department of Anesthesiology The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands

Marcus J Schultz, Prof

Role: STUDY_DIRECTOR

Department of Anaesthesia, General Intensive Care & Pain Management, Medical University of Vienna

Salvatore M Maggiore, Prof

Role: STUDY_CHAIR

Department of Anesthesiology and Intensive Care, Ospedale SS Annunziata & Department of Innovative Technologies in Medicine and Odonto-stomatology, Università Gabriele D'Annunzio di Chieti-Pescara, Chieti, Italy

Ary Serpa Neto, Prof

Role: STUDY_DIRECTOR

Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia