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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711798
• Other study ID #: IRBN172020/CHUSTE
• Status: Completed
• Start date: February 3, 2020
• Est. completion date: May 29, 2020

Study information

• Verified date: February 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 29, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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).
• 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).
• 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).

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid responsiveness measured with PiCCO system during Lung recruitment maneuver.	Measured by PICCO results (phase: 1, 2, 3).	Months: 4
Secondary	Analysis Right cardiac function - Transthoracic echocardiography	measured with Transthoracic echocardiography (phase 1, 3).	Months: 4
Secondary	Analysis Right cardiac function - transoesophageal echocardiography	measured with transoesophageal echocardiography (phase 1, 2).	Months: 4