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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receive cardiac surgery will be included.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients receiving cardiac surgery; 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.

Other: passive leg raising maneuver (PLR); Passive leg raising maneuver (PLR) for preload status evaluation using the PICCO system will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit).; Other: lung recruitment maneuver (LRM); lung recruitment maneuver (LRM) will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit).; Other: echographic evaluation of the right cardiac function; echographic evaluation of the right cardiac function will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis Right cardiac function - Transthoracic echocardiography	measured with Transthoracic echocardiography (phase 1, 3).	Months: 4
Analysis Right cardiac function - transoesophageal echocardiography	measured with transoesophageal echocardiography (phase 1, 2).	Months: 4

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Study Chair: Camille BELLOT, resident, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): May 29, 2020
• Study Completion (Actual): May 29, 2020

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: cardiac surgery; echocardiography; Fluid responsiveness; passive leg raising; Lung recruitment maneuver; right cardiac dysfunction; Transcardiopulmonary Thermodilution; Calibrated Arterial Waveform Analysis
• Other Study ID Numbers: IRBN172020/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No