Prediction of the Effect of Fluid Administration Using Arterial Pressure and Ventilator Data During Abdominal Surgery

Completed

• Conditions: Fluid Overload; Hypovolemia
• Interventions: Other: Series of ventilator settings

• Registration Number: NCT04298931
• Lead Sponsor: University of Aarhus

Brief Summary

It is well known, that patients with circulatory impairment sometimes, but not always, benefit from intravenous fluids. Predicting if a fluid administration will improve circulation is therefore of substantial clinical interest.

Ventilator treatment induces cyclic variation in blood pressure due to interaction between the lungs and the heart. This variation is minor, but its amplitude may be used for guiding fluid administration.

However, this method of using ventilator-induced variation in blood pressure to predict the effect of fluid administration was developed when different settings for ventilator treatment was recommended, compared with today. With today's recommend ventilator treatment, the method is, unfortunately, less reliable.

The investigators will investigate how different ventilator settings influence variation in blood pressure, and the investigators will test if this knowledge allows us to better predict the effect of a fluid administration, by taking the ventilator settings into account.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-06
• Study Start: 2020-05-15
• Status Verified: 2021-04
• Primary Completion: 2021-06-29
• Study Completion: 2021-06-29
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Scheduled open abdominal surgery.
• Scheduled treatment with Aarhus University Hospital's goal-directed therapy protocol (hemodynamic monitoring).

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Exclusion Criteria

• Left ventricular ejection fraction ≤ 40 %
• Irregular heart rhythm (e.g. atrial fibrillation or frequent ectopic beats)
• Known right ventricular dysfunction (if reported qualitatively in pre-operative assessment or objectively via Tricuspid Annular Plane Systolic Excursion (TAPSE) < 17 mm)
• Pregnancy
• Prior participation in this study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing open abdominal surgery	Series of ventilator settings	-

Primary Outcome Measures

Name	Time	Method
>10% Increase in stroke volume from before to after a fluid bolus. (Fluid responsiveness)	From two minutes before to two minutes after a fluid administration.	A patient is considered a fluid responder if they have a \>10% increase in stroke volume (pulse contour analysis by the Edwards EV1000 with a FloTrac sensor).; Pre-fluid stroke volume is calculated as the median stroke volume estimate in the two minutes immediately preceding the fluid bolus.; Post-fluid stroke volume is calculated as the median stroke volume estimate in the two minutes immediately following the fluid bolus.; Change in stroke volume is calculated as: 100% \* (Post-fluid stroke volume - Pre-fluid stroke volume) / Pre-fluid stroke volume

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark