Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled for cardiac surgery using cardiopulmonary bypass

Disqualifiers

BMI >40

Emergency surgery

Advanced grown-up congenital heart disease

Severe pulmonary disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prone position

    Procedure/Surgery

    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).

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Supine positionNo intervention 0 interventions
Group B: Prone positionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cardiac Index

L/min/m2

Time frame
1 hour after baseline

Secondary outcomes

1

PVRi

Difference between and within groups

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

Cardiac Index

Difference between and within groups

Time frame
At baseline. 1 hour after baseline. 1 hour 15 minutes after baseline. 2 hours 15 minutes after baseline. 2 hours 45 minutes after baseline.
3

RV pressure

Looking at differences of right ventricular blood pressure between groups at all timepoints

Time frame
At baseline. 1 hour after baseline. 1 hour 15 minutes after baseline. 2 hours 15 minutes after baseline. 2 hours 45 minutes after baseline.
4

Driving Pressure

Plateau Pressure - PEEP

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

Other outcomes

1

RV contractility during recruitment maneuver

Measured as dP/dt (mmHg/s). Maximum upslope of the pressure waveform measured at the RV.

Time frame
During recruitment (1 hour after baseline).
2

Physiological dead space

Eventual exploratory outcome. Analysis of VD/VT using Enghoff-modified Bohr equations.

Time frame
At baseline. 1 hour after baseline. 1 hour 15 minutes after baseline. 2 hours 15 minutes after baseline. 2 hours 45 minutes after baseline.
3

Subgroup analysis of Cardiac Index

Patients with perioperative or postoperative diagnosed RVF according to a published standardized definition will be analyzed separately in a subgroup analysis.

Time frame
At baseline. 1 hour after baseline. 1 hour 15 minutes after baseline. 2 hours 15 minutes after baseline. 2 hours 45 minutes after baseline.
4

Subgroup analysis of PVRi

Patients with perioperative or postoperative diagnosed RVF according to a published standardized definition will be analyzed separately in a subgroup analysis.

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

Sponsors and contacts

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