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Clinical Trials/NCT04711798
NCT04711798
Completed
N/A

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country20 target enrollmentFebruary 3, 2020
ConditionsCardiac Surgery

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cardiac Surgery
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
20
Locations
1
Primary Endpoint
Fluid responsiveness measured with PiCCO system during Lung recruitment maneuver.
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 3, 2020
End Date
May 29, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Fluid responsiveness measured with PiCCO system during Lung recruitment maneuver.

Time Frame: Months: 4

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

Secondary Outcomes

  • Analysis Right cardiac function - Transthoracic echocardiography(Months: 4)
  • Analysis Right cardiac function - transoesophageal echocardiography(Months: 4)

Study Sites (1)

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