Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery

Cardiopulmonary Bypass Clinical Trial

— VECAR  

Official title:

Beneficial Effects on Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery on Postoperative Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03372174
• Other study ID #: 35RC16_9908_VECAR
• Secondary ID: 2017-A01246-47
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: July 30, 2021

Study information

• Verified date: April 2022
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to measure the incidence of postoperative infections in 2 groups of patients: one group of patients ventilated and one group of patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery, and demonstrate that the incidence of postoperative infections is significantly lower in patients ventilated during cardiopulmonary bypass.

Description:

Cardiopulmonary bypass (CBP) during cardiac surgery induces a systemic inflammatory response associated with an immune dysregulation and a significant pulmonary dysfunction. First, the inflammatory response, usually attributed to surgical trauma, contact of blood with artificial surfaces, and ischemia reperfusion injury, is responsible for a postoperative immunodepression. For instance, an early impairment of lung cellular immune response after CPB, which could promote the development of postoperative pneumonia, has been found. Along these lines, a downregulation of human leukocyte antigen-DR antigen (HLA-DR) expression on monocytes and an increase in plasma interleukin 10 (IL-10) associated with the occurrence of nosocomial infections have been reported. Second, CPB induces a pulmonary dysfunction, which ranges from a temporary and clinically insignificant reduction in arterial oxygenation to a life-threatening injury manifested as acute respiratory distress syndrome (ARDS). This phenomenon is of multifactorial sources, but one of the main mechanisms is the occurrence of atelectasis during surgery. Atelectasis has been associated with lung injury and release of cytokines by shear forces on alveoli and small airways. However, it is not clear whether this injury is due to a recruitment/derecruitment phenomenon (i.e., atelectrauma) or whether it might by itself lead to the release of cytokine. Since CPB mechanically circulates and oxygenates blood bypassing the heart and lungs, usual procedure during CPB is to stop mechanical ventilation (MV) (apnea). Nevertheless, maintaining MV with positive expiratory pressure (PEEP) during CPB diminished the occurrence of atelectasis and the postoperative inflammatory response. Thus, we investigated the effects of maintaining MV during CPB for cardiac surgery on postoperative immunodepression and found that maintaining MV during CPB decreased postoperative immune dysfunction and could be an interesting strategy to diminish the occurrence of postoperative infection (nosocomial infection) without hampering the surgical procedure. However, these findings have to be confirmed in a clinical trial using the incidence of nosocomial infection as an endpoint.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1401
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years old;

• Scheduled for any cardiac surgery (elective surgery) with cardio-pulmonary bypass, aortic clamp and cardioplegia, with median sternotomy and bi-pulmonary ventilation (cardiac valvular surgery (valve replacement or repair), coronary artery surgery, ascending aortic surgery and/or combined);

• Written informed consent.

Exclusion Criteria:

• Emergency surgery ;

• Planned thoracotomy with one lung ventilation ;

• Patients with known respiratory diseases (current respiratory infections, asthma, chronic obstructive or restrictive pulmonary disease, obstructive apnea syndrome) ;

• Patients already intubated in the peri-operative period ;

• Immunodepression defined by proven humoral or cellular deficiency, by continuous administration of steroids at any dose for more than one month prior to hospitalization, high-dose steroids (> 15 mg / kg / day of methylprednisolone or Equivalent), radiotherapy or chemotherapy in the previous year;;

• Need for vasopressor or inotropic agents before surgery ;

• Any acute infection in the last month before surgery ;

• Hematological disorder, autoimmune disease, immunodeficiency, immunosuppressive therapy ;

• Heart failure with an left ventricular ejection fraction<35% ;

• Protected person (adults legally protected (under judicial protection, guardianship, or supervision), person deprived of their liberty.

Related Conditions & MeSH terms

• Cardiopulmonary Bypass

Intervention

Device:
• Maintaining mechanical ventilation during surgery
dead space ventilation using tidal volume of 2.5 mL/kg/pbw (predicted body weight) with 5-7 cm H2O Positive end-expiratory pressure
• Absence of mechanical ventilation during surgery
absence of mechanical ventilation (and no Positive end-expiratory pressure) by disconnecting the tracheal tube from the ventilator

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Bordeaux	Bordeaux
France	CHU Lille	Lille
France	Hôpital Pitié Salpêtrière	Paris
France	CHU Rennes	Rennes
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative infections		During 28 days
Secondary	Expression of human leukocyte antigen-DR antigen (HLA-DR)		At day 0, day 1 and day 7
Secondary	Plasmatic concentration of interleukin 10 (IL10)		At day 0, day 1 and day 7
Secondary	Indoleamine 2,3-Dioxygenase (IDO) activity		At day 0, day 1 and day 7
Secondary	Proportion of myeloid-derived suppressor cells (MDSCs)		At day 0, day 1 and day 7
Secondary	Plasmatic concentration of interleukin 6 (IL-6)		At day 0, day 1 and day 7
Secondary	Quantity of extracellular vesicles (EV)		At day 0 and day 1
Secondary	Occurrence of lymphopenia		At day 0, day 1 and day 7
Secondary	Duration of antibiotic treatment		During 28 days
Secondary	Mortality		During 28 days
Secondary	Length of hospital stay		During 28 days
Secondary	PaO2/FiO2 ratio		At day 0 and day 1
Secondary	Duration of mechanical ventilation		During 28 days