Respiratory ComplicationVENICENCT03255356
Ventilation in Cardiac Surgery
An observational study of Respiratory Complication and Respiration, Artificial, run by University Hospital, Caen at 10 sites in 10 countries.
Trial summary
The purpose of this study is to evaluate prospectively ventilatory practices in the perioperative cardiac surgery period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Complication, Respiration, Artificial, Anesthesia, General
- What is being tested?
- Survey
- How many people
- 1,000 participants
- Where
- 10 sitesin 10 countries
- Study dates
- 1 Nov 2017to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All adult cardiac surgery patients with cardiopulmonary bypass (CPB).
Who may be able to join
- All consecutive cardiac surgery patients with CPB during one predefined period,
- Elective or urgent surgery as defined by EuroSCORE2.
Who cannot join
- Refusal of consent,
- Pregnant women,
- Age < 18 years,
- Heart transplant, ECLS, ventricular assist
- Emergency or salvage surgery as defined by EuroSCORE2
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
Belgium1 site
CUB Erasm, Université libre de Bruxelles
Brussels, 1070
Alexandre Joosten, MD, joosten-alexandre@hotmail.com
Brazil1 site
Universidade Federal de São Paulo (UNIFESP)
Brasil
Caetano Nigro Neto, MD, caenigro@uol.com.br
Czechia1 site
General University Hospital
Prague
Jan Kunstyr, MD, jkunstyr@gmail.com
Germany1 site
Klinik für Anästhesiologie und Intensivmedizin
Jena, 07747
Christoph Sponholz, MD, christoph.sponholz@med.uni-jena.de
Italy1 site
Azienda Ospedaliera Universitaria
Pisa
Fabio Guarracino, MD, f.guarracino@ao-pisa.toscana.it
Japan1 site
Osaka city University Graduate school of Medecine
Ōsaki, 545-8586
Koichi Koichi, MD, suehirokoichi@yahoo.co.jp
Norway1 site
St Olav University Hospital
Trondheim
Idar KIRKEBY-GARSTAD
idar.kirkeby-garstad@ntnu.no
Poland1 site
Wroclaw Medical University
Wroclaw
Waldemar Gozdzik, MD, waldemar.gozdzik@gmail.com
About this study
Official title: International Multicentre Observational Trial of Perioperative Ventilatory Management in Cardiac Surgery
The purpose of this study is to evaluate prospectively ventilatory practices in the perioperative cardiac surgery period.
Read the detailed description
This is a International Multicentre Observational Trial on all adult cardiac surgery patients with cardiopulmonary bypass (CPB).
- Conditions
- Respiratory Complication, Respiration, Artificial, Anesthesia, General, Bypass, Cardiopulmonary
- Being tested
- Survey
- Keywords
- Postoperative pulmonary complications, Protective mechanical ventilation, Alveolar lung recruitment manoeuvres, Cardiac Surgery Procedures
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Also called not adapted
An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of use prophylactic protective mechanical ventilation defined with with low tidal volume (6 to 8 ml / kg based on the ideal body weight)
percent
Measured: 1 day
Secondary outcomes (4)
incidence of using positive end-expiratory pressure
(PEEP)> 5 cmH2O
Measured: 1 day
incidence of using at least 2 alveolar lung recruitment manoeuvres
percent
Measured: 1 day
incidence of using a protective ventilation bundle combining prophylactic protective mechanical ventilation and at least 2 alveolar recruitment manoeuvres
percent
Measured: 1 day
incidence of postoperative pulmonary complications
percent
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start1 Nov 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory ComplicationStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc-Olivier Fischer, MD, PhD, Principal investigator, University Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255356
- Sponsor's protocol ID
- 16-081
- Acronym
- VENICE
- Status last verified
- Mar 2017
- First submitted
- 12 Jun 2017
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
PubMed 23902482Lellouche F, Delorme M, Bussieres J, Ouattara A. Perioperative ventilatory strategies in cardiac surgery. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):381-95. doi: 10.1016/j.bpa.2015.08.006. Epub 2015 Sep 4.
PubMed 26643102Guldner A, Kiss T, Serpa Neto A, Hemmes SN, Canet J, Spieth PM, Rocco PR, Schultz MJ, Pelosi P, Gama de Abreu M. Intraoperative protective mechanical ventilation for prevention of postoperative pulmonary complications: a comprehensive review of the role of tidal volume, positive end-expiratory pressure, and lung recruitment maneuvers. Anesthesiology. 2015 Sep;123(3):692-713. doi: 10.1097/ALN.0000000000000754.
PubMed 26120769
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicentre Observational Trial of Perioperative Ventilatory Management in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03255356
- Acronym / sponsor ID
- VENICE / 16-081
- Conditions
- Respiratory Complication, Respiration, Artificial, Anesthesia, General, Bypass, Cardiopulmonary
- Keywords
- Postoperative pulmonary complications, Protective mechanical ventilation, Alveolar lung recruitment manoeuvres, Cardiac Surgery Procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 21 Aug 2017 (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.
The purpose of this study is to evaluate prospectively ventilatory practices in the perioperative cardiac surgery period.
Detailed description
This is a International Multicentre Observational Trial on all adult cardiac surgery patients with cardiopulmonary bypass (CPB).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Other: SurveyAn anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult cardiac surgery patients with cardiopulmonary bypass (CPB).
Key inclusion criteria (2 listed)
- All consecutive cardiac surgery patients with CPB during one predefined period,
- Elective or urgent surgery as defined by EuroSCORE2.
Key exclusion criteria (5 listed)
- Refusal of consent,
- Pregnant women,
- Age < 18 years,
- Heart transplant, ECLS, ventricular assist
- Emergency or salvage surgery as defined by EuroSCORE2
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 |
|---|---|---|
| SurveyAlso: not adaptedAn anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria. | Other | Cohort |
Primary outcome
incidence of use prophylactic protective mechanical ventilation defined with with low tidal volume (6 to 8 ml / kg based on the ideal body weight)
Time frame: 1 day
percent
4 secondary outcomes
incidence of using positive end-expiratory pressure
Time frame: 1 day
incidence of using at least 2 alveolar lung recruitment manoeuvres
Time frame: 1 day
incidence of using a protective ventilation bundle combining prophylactic protective mechanical ventilation and at least 2 alveolar recruitment manoeuvres
Time frame: 1 day
incidence of postoperative pulmonary complications
Time frame: 1 month postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Background: PubMed 23902482Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
- Background: PubMed 26643102Lellouche F, Delorme M, Bussieres J, Ouattara A. Perioperative ventilatory strategies in cardiac surgery. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):381-95. doi: 10.1016/j.bpa.2015.08.006. Epub 2015 Sep 4.
- Background: PubMed 26120769Guldner A, Kiss T, Serpa Neto A, Hemmes SN, Canet J, Spieth PM, Rocco PR, Schultz MJ, Pelosi P, Gama de Abreu M. Intraoperative protective mechanical ventilation for prevention of postoperative pulmonary complications: a comprehensive review of the role of tidal volume, positive end-expiratory pressure, and lung recruitment maneuvers. Anesthesiology. 2015 Sep;123(3):692-713. doi: 10.1097/ALN.0000000000000754.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Marc-Olivier Fischer, MD, PhD principal investigator
University Hospital of Caen
10 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Complication and Respiration, Artificial, run by University Hospital, Caen at 10 sites in 10 countries.
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 5 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: status not confirmed, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium, Brazil, Czechia, France, Germany and 5 more countries. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc-Olivier Fischer, MD, PhD (+33 2 31 06 31 06, fischer-mo@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of use prophylactic protective mechanical ventilation defined with with low tidal volume (6 to 8 ml / kg based on the ideal body weight) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03255356, which also lists 3 linked publications.
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 21 Aug 2017; AzTrials last refreshed its copy on 27 Oct 2026.