Impact of Lung Recruitment Maneuvers on Driving Pressure in Cardiac Surgery

NCT ID: NCT03976947

Last Updated: 2020-01-21

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

COMPLETED

Total Enrollment

217 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-02-28

Brief Summary

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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

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

Conditions

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Respiration, Artificial Lung Diseases Atelectasis Cardiac Surgical Procedures Anesthesia, General

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients receiving elective or urgent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

* Emergency or salvage surgery
* Patient under guardianship
* Pregnancy
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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Jennifer Brunet, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Caen

Locations

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Caen University Hospital

Caen, , France

Site Status

Countries

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France

References

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Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.

Reference Type BACKGROUND
PMID: 26947624 (View on PubMed)

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)

Other Identifiers

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17-023

Identifier Type: -

Identifier Source: org_study_id

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