Study of Perioperative Evolution of Right Heart Dysfunction and Preload Responsiveness in Open Heart Cardiac Surgery

Completed

• Conditions: Cardiac Surgery
• Interventions: Other: passive leg raising maneuver (PLR); Other: lung recruitment maneuver (LRM); Other: echographic evaluation of the right cardiac function

• Registration Number: NCT04711798
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

The aim of the study was to assess the ability a Lung Recruitment Maneuver (LRM) with a stepwise increase of PEEP to predict fluid responsiveness and right cardiac dysfunction in mechanically ventilated patients in open heart cardiac surgery. During different phases, all patients received a Passive Leg Raising (PLR) maneuver for preload status evaluation using the PICCO system, a Lung Recruitment Maneuver (LRM) and an echographic evaluation of the right cardiac function. 20 patients were analyzed. Incomplete Lung Recruitment Maneuver (LRM) can predict fluid responsiveness at phase 1, pre-operatively, with a sensitivity of 0.57 and specificity of 0.62. Performance of an incomplete Magnetic Resonance Angiography (MRA) to predict right cardiac dysfunction based on TAPSE post-operatively provides a sensitivity and specificity of respectively 0.33 and 0.17 Tolerance to a stepwise lung recruitment maneuver can not be used to evaluate reliably the preload responsiveness and guide fluid therapy except pre-operatively. The use of a lung recruitment maneuver can be a promising method for right cardiac dysfunction screening but further studies need to be done with different echographic tools for right cardiac dysfunction evaluation.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-03
• Primary Completion: 2020-05-29
• Study Completion: 2020-05-29
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients receiving an elective or urgent cardiac surgery with or without extracorporeal circulation under general anesthesia, under protective mechanical ventilation, monitored by invasive arterial blood pressure and pulse contour analysis (PICCO system) for cardiac output measurement and central venous pressure

Exclusion Criteria

• Left ventricular ejection fraction ≤ 30%
• heart arrhythmia, pulmonary hypertension (SPAP > 35 mmHg)
• right heart failure (TAPSE < 16 mm, S' at lateral tricuspid valve < 10 cm/sec)
• lower limbs obstructive arteriopathy (stage IIb, III and IV)
• severe and very severe chronic obstructive pulmonary disease (COPD)
• pneumothorax and extreme weights (BMI < 35 kg/m2).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving cardiac surgery	echographic evaluation of the right cardiac function	Patients receiving cardiac surgery will be included. All patients received a passive leg raising maneuver (PLR) for preload status evaluation using the PICCO system, a lung recruitment maneuver (LRM) and an echographic evaluation of the right cardiac function.
Patients receiving cardiac surgery	lung recruitment maneuver (LRM)	Patients receiving cardiac surgery will be included. All patients received a passive leg raising maneuver (PLR) for preload status evaluation using the PICCO system, a lung recruitment maneuver (LRM) and an echographic evaluation of the right cardiac function.
Patients receiving cardiac surgery	passive leg raising maneuver (PLR)	Patients receiving cardiac surgery will be included. All patients received a passive leg raising maneuver (PLR) for preload status evaluation using the PICCO system, a lung recruitment maneuver (LRM) and an echographic evaluation of the right cardiac function.

Primary Outcome Measures

Name	Time	Method
Fluid responsiveness measured with PiCCO system during Lung recruitment maneuver.	Months: 4	Measured by PICCO results (phase: 1, 2, 3).

Secondary Outcome Measures

Name	Time	Method
Analysis Right cardiac function - Transthoracic echocardiography	Months: 4	measured with Transthoracic echocardiography (phase 1, 3).
Analysis Right cardiac function - transoesophageal echocardiography	Months: 4	measured with transoesophageal echocardiography (phase 1, 2).

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, France