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

NCT04711798 | Completed

• 1 other identifier: IRBN172020/CHUSTE
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery

Keywords

Lung recruitment maneuver; Fluid responsiveness; cardiac surgery; right cardiac dysfunction; passive leg raising; Transcardiopulmonary Thermodilution; Calibrated Arterial Waveform Analysis; echocardiography

Outcome Measures

Primary Outcomes (1)

• Fluid responsiveness measured with PiCCO system during Lung recruitment maneuver.

  Measured by PICCO results (phase: 1, 2, 3).

  Months: 4

Secondary Outcomes (2)

• Analysis Right cardiac function - Transthoracic echocardiography

  Months: 4

• Analysis Right cardiac function - transoesophageal echocardiography

  Months: 4

Study Arms (1)

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); Other: lung recruitment maneuver (LRM); Other: echographic evaluation of the right cardiac function

Interventions

passive leg raising maneuver (PLR) OTHER

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).

Patients receiving cardiac surgery

lung recruitment maneuver (LRM) OTHER

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).

Patients receiving cardiac surgery

echographic evaluation of the right cardiac function OTHER

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).

Patients receiving cardiac surgery

Eligibility Criteria

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

Study Population

Patients receive cardiac surgery will be included.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, France

Location

Study Officials

• Camille BELLOT, resident

  CHU de Saint-Etienne

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 15, 2021
• Study Start: February 3, 2020
• Primary Completion: May 29, 2020
• Study Completion: May 29, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)