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Clinical Trials/NCT07632027
NCT07632027Not yet recruitingNot Applicable

The BAROLO Study Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine Position. Hemodynamic Changes Due to Prone Position in Patients After Cardiac Surgery - a Prospective Randomized Controlled Trial Evaluating the Effect of Prone Position on Right Heart Function

Sahlgrenska University Hospital1 site in 1 country80 target enrollmentStarted: September 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
80
Locations
1

Study Overview

Brief Summary

Right ventricular failure (RVF) is a common complication to cardiac surgery, which is associated to mortality, kidney failure, stroke, prolonged mechanical ventilation and ICU stay. The right ventricle is particularly vulnerable to an increased afterload. By increasing pulmonary vascular resistance (PVR), atelectasis might mitigate a negative effect on the right ventricle.

Recruitment maneuvers have been shown to resolve atelectasis and improve hemodynamics by increasing cardiac output and lowering PVR. However these maneuvers transiently raise airway pressures, which in turn increases right ventricular afterload, a situation often poorly tolerated by patients with RVF.

Prone position is used in patients with respiratory failure and has been shown to decrease mortality in patients with ARDS. Prone position decreases atelectasis and moves ventilation dorsally. In ARDS it also seems to mediate beneficial hemodynamic effects such as an increase in cardiac output and a decrease in PVR.

The investigators hypothesis is that prone position early after cardiac surgery will increase cardiac output by recruitment of atelectasis and thereby decrease PVR.

Detailed Description

Recruitment and consent:

Patients will be screened for participation no later than the day before surgery. Potential participants will be given written and verbal information regarding the study and time to ask questions and consider their participation.

Randomization:

After end of surgery, at baseline in the ICU, patients will be randomly allocated (1:1 ratio) to supine position and prone position. Block randomization with variable block sizes will be performed with sequentially numbered, opaque, sealed envelopes. All performed by Statistiska konsultgruppen. Patient stratification according to cardiac index at end-surgery will be performed to ensure similar allocation of patients with cardiac index <2.2 L/min/m2 in each group. The investigator who enrolls study participants will not have access to the random allocation sequence.

Sample Size:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Scheduled for cardiac surgery using cardiopulmonary bypass

Exclusion Criteria

  • Emergency surgery
  • In need of secondary surgery
  • Advanced grown up congenital heart disease
  • Pulmonary disease
  • Hemodynamic instability with Norepinephrine >0.4mcg/kg/min
  • Any condition which, in the judgement of the investigator, might increase the risk to the patient

Investigators

Sponsor
Sahlgrenska University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Viktor Erbring

Principal Investigator, MD, PhD student, Consultant in Cardiothoracic Anaesthesia and Intensive Care.

Sahlgrenska University Hospital

Study Sites (1)

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