IMPREMO: Impact of Lung Recruitment Maneuvers on Driving Pressure in Cardiac Surgery

Sponsor
University Hospital, Caen (Other)
Overall Status
Completed
CT.gov ID
NCT03976947
Collaborator
(none)
217
1
10
21.8

Study Details

Study Description

Brief Summary

In anesthesia the incidence of postoperative pulmonary complications is frequent, especially in cardiac surgery where the incidence can reach 10%. Respiratory morbidity in cardiac surgery is favored by multiple factors and is higher compared to anesthesia in "general" surgery. The prevention of these complications is a major challenge in the management of patients.

Influence of driving pressure level on respiratory morbidity was first demonstrated in management of acute respiratory distress syndrome (ARDS) in resuscitation.

More recently, this notion has been introduced in anesthesia, with a correlation between increase driving pressure level and increase of post-operative respiratory complications.

A method should reduce these levels of driving pressure: performing lung recruitment maneuvers. This technique has been successfully tested in abdominal surgery in particular in a study published by Futier et al.. They systematized and standardized lung recruitment maneuvers and showed a decrease of postoperative pulmonary complications in abdominal surgery.

Thus, the realization of lung recruitment maneuvers, already used at the discretion of the practitioner, is now recommended by several teams of experts. The investigators propose in this "before-after" trial to evaluate variation in driving pressure due to systematic use of lung recruitment maneuvers, observed in patients operated in elective or urgent surgery. The secondary objective is to evaluate their impact on postoperative pulmonary complications.

Detailed Description

This is a retrospective, before / after, monocentric trial.

Study Design

Study Type:
Observational
Actual Enrollment :
217 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Impact of Lung Recruitment Maneuvers on Driving Pressure in Cardiac Surgery (IMPREMO): Before - After Trial
Actual Study Start Date :
May 1, 2017
Actual Primary Completion Date :
Jan 30, 2018
Actual Study Completion Date :
Feb 28, 2018

Arms and Interventions

Arm Intervention/Treatment
Before group

The "before" group is the control group. We collect retrospective data in consecutive patients operated before the implementation of lung recruitment maneuvers protocol

After group

We collect data in consecutive patients operated after the implementation of lung recruitment maneuvers protocol. This lung recruitment maneuvers will be realised along the surgery, (After tracheal intubation, per-CPB, post-CPB). Each recruitment maneuver consisted of applying a continuous positive airway pressure of 30 cm of water for 30 seconds

Outcome Measures

Primary Outcome Measures

  1. Driving pressure variation due to lung recruitment maneuvers [1 day]

    cmH2O

Secondary Outcome Measures

  1. Incidence of postoperative pulmonary complications [baseline]

    percentage

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patients receiving elective or urgent cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
  • Emergency or salvage surgery

  • Patient under guardianship

  • Pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Caen University Hospital Caen France 14000

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

  • Principal Investigator: Jennifer Brunet, MD, University Hospital of Caen

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT03976947
Other Study ID Numbers:
  • 17-023
First Posted:
Jun 6, 2019
Last Update Posted:
Jan 21, 2020
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Caen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 21, 2020