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

NCT ID: NCT04298931

Last Updated: 2021-07-16

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

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-15

Study Completion Date

2021-06-29

Brief Summary

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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

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Conditions

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Hypovolemia Fluid Overload

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing open abdominal surgery

Series of ventilator settings

Intervention Type 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).

Interventions

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Series of ventilator settings

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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University Hospital

Aarhus N, , Denmark

Site Status

Countries

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Denmark

References

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Enevoldsen J, Brandsborg B, Juhl-Olsen P, Rees SE, Thaysen HV, Scheeren TWL, Vistisen ST. The effects of respiratory rate and tidal volume on pulse pressure variation in healthy lungs-a generalized additive model approach may help overcome limitations. J Clin Monit Comput. 2024 Feb;38(1):57-67. doi: 10.1007/s10877-023-01090-6. Epub 2023 Nov 16.

Reference Type DERIVED
PMID: 37968547 (View on PubMed)

Other Identifiers

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1-10-72-245-19

Identifier Type: -

Identifier Source: org_study_id

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