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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

NCT ID: NCT03635307

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-16

Study Completion Date

2019-02-13

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Blood Volume Expansion

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Operated patients with volume expansion

End Tidal Carbon Dioxide measure

Intervention Type OTHER

End Tidal Carbon Dioxide measures before and after a volume expansion of 250ml of crystalloid in the operating room.

Interventions

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End Tidal Carbon Dioxide measure

End Tidal Carbon Dioxide measures before and after a volume expansion of 250ml of crystalloid in the operating room.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Bordeaux

Bordeaux, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 32863016 (View on PubMed)

Other Identifiers

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CHUBX 2018/18

Identifier Type: -

Identifier Source: org_study_id

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