REVCO2: 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

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Completed
CT.gov ID
NCT03635307
Collaborator
(none)
115
1
5.9
19.3

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Actual Enrollment :
115 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 :
Aug 16, 2018
Actual Primary Completion Date :
Feb 13, 2019
Actual Study Completion Date :
Feb 13, 2019

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. End Tidal Carbon Dioxide measure [Beggining time of volume expansion of 250ml of crystalloid during surgery]

  2. End Tidal Carbon Dioxide measure [1 minute after the end of volume expansion of 250ml of crystalloid during surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 CHU de Bordeaux Bordeaux France

Sponsors and Collaborators

  • University Hospital, Bordeaux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT03635307
Other Study ID Numbers:
  • CHUBX 2018/18
First Posted:
Aug 17, 2018
Last Update Posted:
Jan 22, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 22, 2020