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Ability of Changes in End Tidal Carbon Dioxide to Assess the Stroke Volume Effects of a Volume Expansion of 250ml of Crystalloid in the Operating Room (REVCO2)

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ClinicalTrials.gov Identifier: NCT03635307
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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Brief Summary:
Volume expansion is the cornerstone of perioperative hemodynamic optimization. The main objective of volume expansion is to increase and to maximize stroke volume. Despite national and international recommendations, stroke volume monitoring is clearly not widely adopted. This is mostly due to the cost and the invasiveness of the devices allowing stroke volume monitoring. End tidal carbon dioxide is monitored in all patients undergoing general anaesthesia and is totally non-invasive. A strong relationship between stroke volume and end tidal carbon dioxide have been already demonstrated. The aim of the present study is to determine if change in End Tidal Carbon Dioxide can assess the stroke volume effects of a volume expansion of 250ml of crystalloid in the operating room

Condition or disease Intervention/treatment
Blood Volume Expansion Other: End Tidal Carbon Dioxide measure

Detailed Description:

The main objective of volume expansion is to increase stroke volume. Franck-Starling curve is schematically divided into two portions: a vertical portion which mean that an increase in preload secondary to volume expansion will induce an increase in stroke volume; and a flat portion which mean that a same increase in preload will not induce an increase in stroke volume. Perioperative optimization is based on stroke volume maximization using volume expansion. Despite national and international recommendations, stroke volume monitoring is clearly not widely adopted. This is mostly due to the cost and the invasiveness of the devices allowing stroke volume monitoring. End tidal carbon dioxide is monitored in all patients undergoing general anaesthesia and is totally non-invasive. Several studies evaluated the relationship between stroke volume and end tidal carbon dioxide and other studies evaluated the ability of changes in end tidal carbon dioxide to assess changes in stroke volume induced by volume expansion with discordant results. These studies included small sample size and were heterogeneous (intensive care unit and nor operating room, volume expansion or passive leg raising, crystalloid or colloid, 500ml and not 250 ml ….). Nowadays, it is not clear if changes in end tidal carbon dioxide can be considered as a surrogate of changes in stroke volume during a volume expansion in operating room patients. Thus, the aim of the present study is to determine if change in End Tidal Carbon Dioxide can assess the stroke volume effects of a volume expansion of 250ml of crystalloid in the operating room.

The follow up will be restricted to the duration of volume expansion. The last data will be collected just after the end of volume expansion.


Study Design
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Study Type : Observational
Estimated Enrollment : 104 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ability of Changes in End Tidal Carbon Dioxide to Assess the Stroke Volume Effects of a Volume Expansion of 250ml of Crystalloid in the Operating Room
Actual Study Start Date : August 16, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Operated patients with volume expansion Other: End Tidal Carbon Dioxide measure
End Tidal Carbon Dioxide measures before and after a volume expansion of 250ml of crystalloid in the operating room.


Outcome Measures
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Primary Outcome Measures :
  1. End Tidal Carbon Dioxide measure [ Time Frame: Beggining time of volume expansion of 250ml of crystalloid during surgery ]
  2. End Tidal Carbon Dioxide measure [ Time Frame: 1 minute after the end of volume expansion of 250ml of crystalloid during surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patient older than 18 years scheduled for neurosurgery in prone position, equipped from an arterial catheter and stroke volume monitoring in Bordeaux University Hospital
Criteria

Inclusion Criteria:

  • Patient older than 18 years
  • Scheduled for neurosurgery in prone position
  • Equipped from an arterial catheter and stroke volume monitoring

Exclusion Criteria:

Patient with cardiac dysfunction and/or lung disease

Contacts and Locations
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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): NCT03635307


Contacts
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Contact: Matthieu BIAIS, MD-PhD 05 57 82 10 19 ext +33 matthieu.biais@chu-bordeaux.fr
Contact: Olivier BRANCHARD 05 57 82 06 97 ext +33 olivier.branchard@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux Recruiting
Bordeaux, France
Contact: Matthieu BIAIS, MD-PhD    05 57 82 10 19 ext +33    matthieu.biais@chu-bordeaux.fr   
Contact: Olivier BRANCHARD    05 57 82 06 97 ext +33    olivier.branchard@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03635307     History of Changes
Other Study ID Numbers: CHUBX 2018/18
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Blood Volume expansion
Fluid responsiveness
Stroke volume
Perioperative optimization
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases