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| Name | Class |
|---|---|
| University Of Perugia | OTHER |
| University of Chieti | OTHER |
| Medical University of Vienna | OTHER |
| The Netherlands Cancer Institute |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative mechanical ventilation | Patients subjected to invasive mechanical ventilation (IMV) during general anesthesia for surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative mechanical ventilation for surgery | Other | Any IMV during general anesthesia for surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pulmonary complications (PPCs) | Incidence and type of PPCs | within 5 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative adverse events (IAEs) | Incidence and type of IAEs | Intraoperatively |
| Intraoperative mechanical ventilation practice | Mechanical ventilation settings in patients undergoing general anesthesia for surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients subjected to IMV during general anesthesia for surgery will be included in a consecutive manner
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gianmaria Cammarota, Prof | Contact | +393213733406 | gianmaria.cammarota@uniupo.it | |
| Rachele Simonte, MD | Contact | rachele.simonte@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gianmaria Cammarota, Prof | Università degli Studi del Piemonte Orientale | Principal Investigator |
| Rachele Simonte, MD | University Of Perugia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria di Alessandria | Recruiting | Alessandria | Italy | Italy |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| OTHER |
| Monash University | OTHER |
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| Intraoperatively |
| Postoperative clinical outcome | Hospital mortality | Postoperatively, on day 28 following surgery |
| Edoardo M De Robertis, Prof |
| University Of Perugia |
| Study Director |
| Sabrine N.T. Hemmes, MD | Department of Anesthesiology The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands | Study Director |
| Marcus J Schultz, Prof | Department of Anaesthesia, General Intensive Care & Pain Management, Medical University of Vienna | Study Director |
| Salvatore M Maggiore, Prof | 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 | Study Chair |
| Ary Serpa Neto, Prof | Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia | Study Director |