Clinical trial NCT03976947: Impact of Lung Recruitment Maneuvers on Driving Pressure in Cardiac Surgery
Official title: Impact of Lung Recruitment Maneuvers on Driving Pressure in Cardiac Surgery (IMPREMO): Before - After Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiration, Artificial
Lung Diseases
Atelectasis
Cardiac Surgical Procedures
Anesthesia, General
Keywords: Driving pressure
Postoperative pulmonary complications
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving cardiac surgery with cardiopulmonary bypass

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.

Eligibility criteria: Inclusion Criteria:

* Patients receiving elective or urgent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Emergency or salvage surgery
* Patient under guardianship
* Pregnancy

Primary outcomes:
measure: Driving pressure variation due to lung recruitment maneuvers
timeFrame: 1 day
Secondary outcomes:
measure: Incidence of postoperative pulmonary complications
timeFrame: baseline
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: University Hospital of Caen
name: Jennifer Brunet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.