Completed

NCT Number: NCT04298931

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

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.

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Key information

Conditions

Hypovolemia Edema Fluid Overload Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Series of ventilator settings

Other

Before a planned fluid administration, the investigators will apply a series of 10 ventilator settings for 30 seconds each.

The settings are the following combinations of respiratory rate (RR) and tidal volume (TV):

RR (min^-1), TV (ml/kg predicted body weight)

31, 6

31, 8

24, 6

24, 8

17, 6

17, 8

10, 4

10, 6

10, 8

10, 10

(the order of the respiratory rates: 17 to 31, will be randomized. 10/min will always be last. Tidal volume is always applied from lowest to highest for each respiratory rate).

Primary outcomes

>10% Increase in stroke volume from before to after a fluid bolus. (Fluid responsiveness)

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

Aarhus University Hospital

Registry information

Official study title

Fluid Responsiveness Prediction Using Pulse Pressure Variation - Integrating Ventilator Settings

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Mar 6, 2020
Registry last updated: Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed