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

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT04298931
Collaborator
Aarhus University Hospital (Other)
52
1
13.5
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Series of ventilator settings

Study Design

Study Type:
Observational
Actual Enrollment :
52 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Fluid Responsiveness Prediction Using Pulse Pressure Variation - Integrating Ventilator Settings
Actual Study Start Date :
May 15, 2020
Actual Primary Completion Date :
Jun 29, 2021
Actual Study Completion Date :
Jun 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Patients undergoing open abdominal surgery

Other: 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).

Outcome Measures

Primary Outcome Measures

  1. >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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aarhus University Hospital Aarhus N Denmark 8200

Sponsors and Collaborators

  • University of Aarhus
  • Aarhus University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT04298931
Other Study ID Numbers:
  • 1-10-72-245-19
First Posted:
Mar 6, 2020
Last Update Posted:
Jul 16, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 16, 2021