Ventilation in Cardiac Surgery

NCT ID: NCT03255356

Last Updated: 2017-08-21

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

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2017-12-31

Brief Summary

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The purpose of this study is to evaluate prospectively ventilatory practices in the perioperative cardiac surgery period.

Detailed Description

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This is a International Multicentre Observational Trial on all adult cardiac surgery patients with cardiopulmonary bypass (CPB).

Conditions

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Respiratory Complication Respiration, Artificial Anesthesia, General Bypass, Cardiopulmonary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.

Survey

Intervention Type OTHER

An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.

Interventions

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Survey

An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.

Intervention Type OTHER

Other Intervention Names

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not adapted

Eligibility Criteria

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Inclusion Criteria

* All consecutive cardiac surgery patients with CPB during one predefined period,
* Elective or urgent surgery as defined by EuroSCORE2.

Exclusion Criteria

* Refusal of consent,
* Pregnant women,
* Age \< 18 years,
* Heart transplant, ECLS, ventricular assist
* Emergency or salvage surgery as defined by EuroSCORE2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc-Olivier Fischer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Caen

Locations

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CUB Erasm, Université libre de Bruxelles

Brussels, , Belgium

Site Status

Universidade Federal de São Paulo (UNIFESP)

Brasil, , Brazil

Site Status

General University Hospital

Prague, , Czechia

Site Status

Caen University Hospital

Caen, , France

Site Status

Klinik für Anästhesiologie und Intensivmedizin

Jena, , Germany

Site Status

Azienda Ospedaliera Universitaria

Pisa, , Italy

Site Status

Osaka city University Graduate school of Medecine

Ōsaki, , Japan

Site Status

VU University Hospital

Amsterdam, , Netherlands

Site Status

St Olav University Hospital

Trondheim, , Norway

Site Status

Wroclaw Medical University

Wroclaw, , Poland

Site Status

Countries

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Belgium Brazil Czechia France Germany Italy Japan Netherlands Norway Poland

Central Contacts

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Marc-Olivier Fischer, MD, PhD

Role: CONTACT

+33 2 31 06 31 06

Jennifer Brunet, MD

Role: CONTACT

33 2 31 06 31 06

Facility Contacts

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Alexandre Joosten, MD

Role: primary

Caetano Nigro Neto, MD

Role: primary

Jan Kunstyr, MD

Role: primary

Christoph Sponholz, MD

Role: primary

Fabio Guarracino, MD

Role: primary

Koichi Koichi, MD

Role: primary

Idar KIRKEBY-GARSTAD

Role: primary

Role: backup

Waldemar Gozdzik, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 23902482 (View on PubMed)

Lellouche 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.

Reference Type BACKGROUND
PMID: 26643102 (View on PubMed)

Guldner 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.

Reference Type BACKGROUND
PMID: 26120769 (View on PubMed)

Other Identifiers

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16-081

Identifier Type: -

Identifier Source: org_study_id

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