Postoperative Complications, Surgery, Ventilator Lung
Conditions
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.
Interventions
Any IMV during general anesthesia for surgery
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pulmonary complications (PPCs) | within 5 days after surgery | Incidence and type of PPCs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative adverse events (IAEs) | Intraoperatively | Incidence and type of IAEs |
| 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 |
Countries
Italy
Contacts
Università degli Studi del Piemonte Orientale
University Of Perugia
University Of Perugia
Department of Anesthesiology The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands
Department of Anaesthesia, General Intensive Care & Pain Management, Medical University of Vienna
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
Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia