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Completed

NCT Number: NCT02678559

Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres

The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations will be measured on preload dependency or preload independency status. The principal purpose is to determine if variations of stroke volume during standardized ARM can predict the preload dependency status.

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Key information

Conditions

Coronary Artery Disease Anesthesia, General Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Bypass Coronary Disease Heart Diseases Hypovolemia Lung Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Atelectasis Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

Population studied: anesthetized patients for cardiac surgery of coronary bypass.

Secondary endpoints : - comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM. These mini-invasive systems are : Clearsight system (Edwards Lifescience) and Flotrac system (Edwards Lifescience)

  • Difference between pre and post-cardiopulmonary bypass status on principal purpose evaluation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient Undergoing a surgical procedure of coronary artery bypass, with cardiopulmonary bypass Written consent collected

Exclusion criteria

  • Emergency case
  • Pericardial effusion
  • Aortic or mitral valvulopathy
  • Contraindication for : TEE, alveolar recruitment manoeuvre (emphysema, pneumothorax, hemodynamic instability), Ringer Lactate solution infusion
  • Bad echogenicity
  • Patient refusal to participate to the study
  • No health insurance

Treatment and study plan

tee measurement

Other

flotrac measurement

Other

clearsight measurement

Other

Primary outcomes

  1. Variation of stroke volume

    Time frame: at the beginning of cardiac surgery

    Variation of stroke volume measured by TEE, induced by a standardized ARM, at the beginning of cardiac surgery

Secondary outcomes

  1. Velocity time integral (cm)

    Time frame: at the begining of cardiac surgery

    Velocity time integral (cm) (TEE measurement)

  2. Velocity time integral (cm)

    Time frame: After fluid challenges until patient is on a preload independency state.

    Velocity time integral (cm) (TEE measurement)

  3. Velocity time integral (cm)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

    Velocity time integral (cm) (TEE measurement)

  4. Cardiac index (l/min/m2)

    Time frame: at the begining of cardiac surgery

    Cardiac index (l/min/m2) (TEE measurement)

  5. Cardiac index (l/min/m2)

    Time frame: After fluid challenges until patient is on a preload independency state.

    Cardiac index (l/min/m2) (TEE measurement)

  6. Cardiac index (l/min/m2)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

    Cardiac index (l/min/m2) (TEE measurement)

  7. Right ventricle diameter/left ventricle diameter ratio

    Time frame: at the begining of cardiac surgery

    Right ventricle diameter/left ventricle diameter ratio (TEE measurement),

  8. Right ventricle diameter/left ventricle diameter ratio

    Time frame: After fluid challenges until patient is on a preload independency state.

    Right ventricle diameter/left ventricle diameter ratio (TEE measurement),

  9. Right ventricle diameter/left ventricle diameter ratio

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

    Right ventricle diameter/left ventricle diameter ratio (TEE measurement),

  10. E/A ratio

    Time frame: at the begining of cardiac surgery

    E/A ratio (TEE measurement)

  11. E/A ratio

    Time frame: After fluid challenges until patient is on a preload independency state.

    E/A ratio (TEE measurement)

  12. E/A ratio

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

    E/A ratio (TEE measurement)

  13. Sus-hepatic vein Doppler profile

    Time frame: at the begining of cardiac surgery

    Sus-hepatic vein Doppler profile (TEE measurement)

  14. Sus-hepatic vein Doppler profile

    Time frame: After fluid challenges until patient is on a preload independency state.

    Sus-hepatic vein Doppler profile (TEE measurement)

  15. Sus-hepatic vein Doppler profile

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

    Sus-hepatic vein Doppler profile (TEE measurement)

  16. Invasive arterial pressure (mmHg)

    Time frame: at the begining of cardiac surgery

  17. Invasive arterial pressure (mmHg)

    Time frame: After fluid challenges until patient is on a preload independency state.

  18. Invasive arterial pressure (mmHg)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  19. Heart rate (pulse/min)

    Time frame: at the begining of cardiac surgery

  20. Heart rate (pulse/min)

    Time frame: After fluid challenges until patient is on a preload independency state.

  21. Heart rate (pulse/min)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  22. Expired CO2 (mmHg)

    Time frame: at the begining of cardiac surgery

  23. Expired CO2 (mmHg)

    Time frame: After fluid challenges until patient is on a preload independency state.

  24. Expired CO2 (mmHg)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  25. Central venous pressure (mmHg)

    Time frame: at the begining of cardiac surgery

  26. Central venous pressure (mmHg)

    Time frame: After fluid challenges until patient is on a preload independency state.

  27. Central venous pressure (mmHg)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  28. Pulse pressure variation (%)

    Time frame: at the begining of cardiac surgery

  29. Pulse pressure variation (%)

    Time frame: After fluid challenges until patient is on a preload independency state.

  30. Pulse pressure variation (%)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  31. Perfusion index (pulsoxymeter)

    Time frame: at the begining of cardiac surgery

  32. Perfusion index (pulsoxymeter)

    Time frame: After fluid challenges until patient is on a preload independency state.

  33. Perfusion index (pulsoxymeter)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  34. Stroke volume (ml) (Flotrac measurement)

    Time frame: at the begining of cardiac surgery

  35. Stroke volume (ml) (Flotrac measurement)

    Time frame: After fluid challenges until patient is on a preload independency state.

  36. Stroke volume (ml) (Flotrac measurement)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  37. Stroke volume variation (%) (Flotrac measurement)

    Time frame: at the begining of cardiac surgery

  38. Stroke volume variation (%) (Flotrac measurement)

    Time frame: After fluid challenges until patient is on a preload independency state.

  39. Stroke volume variation (%) (Flotrac measurement)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  40. Cardiac index (l/min/m2) (Flotrac measurement)

    Time frame: at the begining of cardiac surgery

  41. Cardiac index (l/min/m2) (Flotrac measurement)

    Time frame: After fluid challenges until patient is on a preload independency state.

  42. Cardiac index (l/min/m2) (Flotrac measurement)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  43. Pulse pressure variation (%) (Flotrac measurement)

    Time frame: at the begining of cardiac surgery

  44. Pulse pressure variation (%) (Flotrac measurement)

    Time frame: After fluid challenges until patient is on a preload independency state.

  45. Pulse pressure variation (%) (Flotrac measurement)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  46. Arterial pressure (mmHg) (Flotrac measurement)

    Time frame: at the begining of cardiac surgery

  47. Arterial pressure (mmHg) (Flotrac measurement)

    Time frame: After fluid challenges until patient is on a preload independency state.

  48. Arterial pressure (mmHg) (Flotrac measurement)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  49. Stroke volume (ml) (Clearsight measurement)

    Time frame: at the begining of cardiac surgery

  50. Stroke volume (ml) (Clearsight measurement)

    Time frame: After fluid challenges until patient is on a preload independency state.

  51. Stroke volume (ml) (Clearsight measurement)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  52. Stroke volume variation (%) (Clearsight measurement)

    Time frame: at the begining of cardiac surgery

  53. Stroke volume variation (%) (Clearsight measurement)

    Time frame: After fluid challenges until patient is on a preload independency state.

  54. Stroke volume variation (%) (Clearsight measurement)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  55. Cardiac index (l/min/m2) (Clearsight measurement)

    Time frame: at the begining of cardiac surgery

  56. Cardiac index (l/min/m2) (Clearsight measurement)

    Time frame: After fluid challenges until patient is on a preload independency state.

  57. Cardiac index (l/min/m2) (Clearsight measurement)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  58. Pulse pressure variation (%) (Clearsight measurement)

    Time frame: at the begining of cardiac surgery

  59. Pulse pressure variation (%) (Clearsight measurement)

    Time frame: After fluid challenges until patient is on a preload independency state.

  60. Pulse pressure variation (%) (Clearsight measurement)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  61. Arterial pressure (mmHg) (Clearsight measurement)

    Time frame: at the begining of cardiac surgery

  62. Arterial pressure (mmHg) (Clearsight measurement)

    Time frame: After fluid challenges until patient is on a preload independency state.

  63. Arterial pressure (mmHg) (Clearsight measurement)

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

  64. Near infrared spectroscopy : Cerebral SrO2

    Time frame: at the begining of cardiac surgery

  65. Near infrared spectroscopy : Cerebral SrO2

    Time frame: After fluid challenges until patient is on a preload independency state.

  66. Near infrared spectroscopy : Cerebral SrO2

    Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: PreDeARM

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2016
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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