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)

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

Study Overview

• Status: Completed
• Conditions: Blood Volume Expansion
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
End Tidal Carbon Dioxide measure	Beggining time of volume expansion of 250ml of crystalloid during surgery
End Tidal Carbon Dioxide measure	1 minute after the end of volume expansion of 250ml of crystalloid during surgery

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Publications and helpful links

General Publications

• de Courson H, Chauvet J, Le Gall L, Georges D, Boyer P, Verchere 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2018
• Primary Completion (Actual): February 13, 2019
• Study Completion (Actual): February 13, 2019

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Fluid responsiveness; Stroke volume; Blood Volume expansion; Perioperative optimization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: CHUBX 2018/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No