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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04711798
Enrollment
20
Registered
2021-01-15
Start date
2020-02-03
Completion date
2020-05-29
Last updated
2021-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

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

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.

Interventions

OTHERpassive 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).

OTHERlung 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).

OTHERechographic 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).

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Analysis Right cardiac function - Transthoracic echocardiographyMonths: 4measured with Transthoracic echocardiography (phase 1, 3).
Analysis Right cardiac function - transoesophageal echocardiographyMonths: 4measured with transoesophageal echocardiography (phase 1, 2).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026