Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine Position

NCT07632027 | Not Yet Recruiting

• 1 other identifier: 286380
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Right Ventricular Function; Prone Position; Atelectasis; Cardiac Output; Vasoconstriction; Heart Failure; Recruitment Maneuver; Pulmonary Arterial Pressure; Cardiac Surgery; Atelectases, Postoperative Pulmonary; Respiratory Mechanics; Cardiac Surgery Recovery; Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

• Cardiac Index

  L/min/m2

  1 hour after baseline

Secondary Outcomes (15)

• PVRi

  At baseline. 1 hour after baseline. 1 hour 15 minutes after baseline. 2 hours 15 minutes after baseline. 2 hours 45 minutes after baseline.

• Cardiac Index

  At baseline. 1 hour after baseline. 1 hour 15 minutes after baseline. 2 hours 15 minutes after baseline. 2 hours 45 minutes after baseline.

• PaO2:FiO2

  At baseline. 1 hour after baseline. 1 hour 15 minutes after baseline. 2 hours 15 minutes after baseline. 2 hours 45 minutes after baseline.

• Driving Pressure

  At baseline. 1 hour after baseline. 1 hour 15 minutes after baseline. 2 hours 15 minutes after baseline. 2 hours 45 minutes after baseline.

• ICU length of stay

  Perioperative

Other Outcomes (4)

• RV contractility during recruitment maneuver

  During recruitment (1 hour after baseline).

• Physiological dead space

  At baseline. 1 hour after baseline. 1 hour 15 minutes after baseline. 2 hours 15 minutes after baseline. 2 hours 45 minutes after baseline.

• Subgroup analysis of Cardiac Index

  At baseline. 1 hour after baseline. 1 hour 15 minutes after baseline. 2 hours 15 minutes after baseline. 2 hours 45 minutes after baseline.

Study Arms (2)

Supine position

NO INTERVENTION

Control group. Will remain in supine position for the whole protocol.

Prone position

EXPERIMENTAL

Will be turned to prone position after baseline data collection (0) and return to supine position before the final data collection (t4).

Procedure: Prone position

Interventions

Prone position PROCEDURE

Prone position is applied in the intervention group immediately after randomization, patients will be prone for a total of 2 hours and 15 minutes. During this time 3 data collection points occur (t1, t2 \& t3).

Prone position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for cardiac surgery using cardiopulmonary bypass

You may not qualify if:

• BMI \>40
• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Cardiac Intensive Care Unit

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Heart Failure

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Viktor Erbring, MD

CONTACT

+46706456664; viktor.erbring@vgregion.se

Per Persson, MD, PhD

CONTACT

+46736467042; per.persson@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD student, Consultant in Cardiothoracic Anaesthesia and Intensive Care.

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)