SurgeryMEET VENUSNCT06296277
Mechanical Ventilation in Surgical Patients
An observational study of Surgery and Ventilator Lung, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Ventilator Lung, Postoperative Complications
- What is being tested?
- Intraoperative mechanical ventilation for surgery
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2026to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients subjected to IMV during general anesthesia for surgery will be included in a consecutive manner
Who may be able to join
- Adults; and
- Receiving intraoperative IMV (via tracheal intubation, or supraglottic device ) during general anesthesia for surgery
Who cannot join
- Receiving intraoperative IMV outside of an operating room; and
- Receiving intraoperative IMV during extracorporeal life support
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rachele Simonte, MD contact
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria di Alessandria
Alessandria, Italy
Gianmaria Cammarota, Associate Professor, +390131206252, gianmaria.cammarota@uniupo.it
About this study
Official title: Management of Mechanical Ventilation During Surgery: an International, Multicenter, and Observational Data Registry
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
Read the 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.
- Conditions
- Surgery, Ventilator Lung, Postoperative Complications
- Being tested
- Intraoperative mechanical ventilation for surgery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative mechanical ventilation for surgeryOther
Any IMV during general anesthesia for surgery
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative mechanical ventilation | Patients subjected to invasive mechanical ventilation (IMV) during general anesthesia for surgery Receives: Other: Intraoperative mechanical ventilation for surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complications (PPCs)
Incidence and type of PPCs
Measured: within 5 days after surgery
Secondary outcomes (3)
Intraoperative adverse events (IAEs)
Incidence and type of IAEs
Measured: Intraoperatively
Intraoperative mechanical ventilation practice
Mechanical ventilation settings in patients undergoing general anesthesia for surgery
Measured: Intraoperatively
Postoperative clinical outcome
Hospital mortality
Measured: Postoperatively, on day 28 following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Mar 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Collaborators
- University Of Perugia, University of Chieti, Medical University of Vienna, The Netherlands Cancer Institute, Monash University
- Responsible party
- Principal investigator, Gianmaria Cammarota, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Investigators
- Gianmaria Cammarota, Prof, Principal investigator, Università degli Studi del Piemonte OrientaleRachele Simonte, MD, Study director, University Of PerugiaEdoardo M De Robertis, Prof, Study director, University Of PerugiaSabrine N.T. Hemmes, MD, Study director, Department of Anesthesiology The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The NetherlandsMarcus J Schultz, Prof, Study director, Department of Anaesthesia, General Intensive Care & Pain Management, Medical University of ViennaSalvatore M Maggiore, Prof, 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, ItalyAry Serpa Neto, Prof, Study director, Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296277
- Sponsor's protocol ID
- UPO#1!
- Acronym
- MEET VENUS
- Status last verified
- May 2026
- First submitted
- 29 Feb 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Mechanical Ventilation During Surgery: an International, Multicenter, and Observational Data Registry
- ClinicalTrials.gov ID
- NCT06296277
- Acronym / sponsor ID
- MEET VENUS / UPO#1!
- Conditions
- Surgery, Ventilator Lung, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Collaborators
- University Of Perugia, University of Chieti, Medical University of Vienna, The Netherlands Cancer Institute, Monash University
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative mechanical ventilation | – | Other: Intraoperative mechanical ventilation for surgeryPatients subjected to invasive mechanical ventilation (IMV) during general anesthesia for surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients subjected to IMV during general anesthesia for surgery will be included in a consecutive manner
Key inclusion criteria (2 listed)
- Adults; and
- Receiving intraoperative IMV (via tracheal intubation, or supraglottic device ) during general anesthesia for surgery
Key exclusion criteria (2 listed)
- Receiving intraoperative IMV outside of an operating room; and
- Receiving intraoperative IMV during extracorporeal life support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative mechanical ventilation for surgeryAny IMV during general anesthesia for surgery | Other | Intraoperative mechanical ventilation |
Primary outcome
Postoperative pulmonary complications (PPCs)
Time frame: within 5 days after surgery
Incidence and type of PPCs
3 secondary outcomes
Intraoperative adverse events (IAEs)
Time frame: Intraoperatively
Intraoperative mechanical ventilation practice
Time frame: Intraoperatively
Postoperative clinical outcome
Time frame: Postoperatively, on day 28 following surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachele Simonte, MD contact
Gianmaria Cammarota, Prof principal investigator
Università degli Studi del Piemonte Orientale
Rachele Simonte, MD study director
University Of Perugia
Edoardo M De Robertis, Prof study director
University Of Perugia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Ventilator Lung, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianmaria Cammarota, Prof (+393213733406, gianmaria.cammarota@uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complications (PPCs) (time frame: within 5 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.