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Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres (PreDeARM)

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ClinicalTrials.gov Identifier: NCT02678559
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Artery Bypass Hypovolemia Anesthesia, General Pulmonary Atelectasis Other: tee measurement Other: flotrac measurement Other: clearsight measurement Not Applicable

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres
Actual Study Start Date : February 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: TEE monitory system
comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.
Other: tee measurement
Other: flotrac measurement
Other: clearsight measurement
Experimental: mini-invasive monitoring system
comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.
Other: tee measurement
Other: flotrac measurement
Other: clearsight measurement



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678559


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02678559    
Other Study ID Numbers: CHU-0254
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Keywords provided by University Hospital, Clermont-Ferrand:
Alveolar recruitment manoeuvre
Lung recruitment
Preload dependency
Cardiac surgery
Transoesophageal echocardiography
Additional relevant MeSH terms:
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Pulmonary Atelectasis
Coronary Artery Disease
Hypovolemia
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes