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Status unknownNCT03255356VENICEUpdated Aug 21, 2017

Ventilation in Cardiac Surgery

An observational study in Respiratory Complication, Respiration, Artificial and Anesthesia, General, sponsored by University Hospital, Caen. Status unknown at 10 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-21.

Sponsored by University Hospital, Caen · Observational

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Respiratory Complication
  • Respiration, Artificial
  • Anesthesia, General
  • Bypass, Cardiopulmonary

Keywords

  • Postoperative pulmonary complications
  • Protective mechanical ventilation
  • Alveolar lung recruitment manoeuvres
  • Cardiac Surgery Procedures
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All adult cardiac surgery patients with cardiopulmonary bypass (CPB).

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Refusal of consent,
  • Pregnant women,
  • Age \< 18 years,
  • Heart transplant, ECLS, ventricular assist
  • Emergency or salvage surgery as defined by EuroSCORE2
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cohort

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

    Other: Survey

Interventions

  • OtherSurvey

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

    Also known as: not adapted

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 day

Secondary outcomes

  1. incidence of using positive end-expiratory pressure

    (PEEP)\> 5 cmH2O

    Time frame: 1 day

  2. incidence of using at least 2 alveolar lung recruitment manoeuvres

    percent

    Time frame: 1 day

  3. incidence of using a protective ventilation bundle combining prophylactic protective mechanical ventilation and at least 2 alveolar recruitment manoeuvres

    percent

    Time frame: 1 day

  4. incidence of postoperative pulmonary complications

    percent

    Time frame: 1 month postoperatively

06

Study locations

10 sites
07

References and documents

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 23902482 ↗
  • 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. PubMed 26643102 ↗
  • 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. PubMed 26120769 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03255356
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Aug 21, 2017
Start date
Nov 1, 2017 (estimated)
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Aug 21, 2017

Study contacts

Marc-Olivier Fischer, MD, PhD
Contact
fischer-mo@chu-caen.fr
+33 2 31 06 31 06
Jennifer Brunet, MD
Contact
brunet-j@chu-caen.fr
33 2 31 06 31 06
Marc-Olivier Fischer, MD, PhD
principal investigator · University Hospital of Caen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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