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Trial record 19 of 2064 for:    CARBON DIOXIDE AND dioxide

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 : Completed
First Posted : August 17, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date August 8, 2018
First Posted Date August 17, 2018
Last Update Posted Date January 22, 2020
Actual Study Start Date August 16, 2018
Actual Primary Completion Date February 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 14, 2018)
  • End Tidal Carbon Dioxide measure [ Time Frame: Beggining time of volume expansion of 250ml of crystalloid during surgery ]
  • End Tidal Carbon Dioxide measure [ Time Frame: 1 minute after the end of volume expansion of 250ml of crystalloid during surgery ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
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
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Blood Volume Expansion
Intervention 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.
Study Groups/Cohorts Operated patients with volume expansion
Intervention: Other: End Tidal Carbon Dioxide measure
Publications * de Courson H, Chauvet J, Le Gall L, Georges D, Boyer P, Verchère E, Nouette-Gaulain K, Biais M. Utility of changes in end-tidal carbon dioxide after volume expansion to assess fluid responsiveness in the operating room: a prospective observational study. Br J Anaesth. 2020 Nov;125(5):672-679. doi: 10.1016/j.bja.2020.07.018. Epub 2020 Aug 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 21, 2020)
115
Original Estimated Enrollment
 (submitted: August 14, 2018)
104
Actual Study Completion Date February 13, 2019
Actual Primary Completion Date February 13, 2019   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03635307
Other Study ID Numbers CHUBX 2018/18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study Sponsor University Hospital, Bordeaux
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Bordeaux
Verification Date January 2020