Correlation Between Duration of Fasting and Response to Fluid Replenishment, Evaluated With Repeated Measures of VTI.

July 24, 2018 updated by: Erasme University Hospital

Corrélation Entre la Longueur de jeûne et la réponse au Remplissage Vasculaire évaluée Par Des Mesures répétées de l'ITV.

The investigators will study the correlation between the lenght of the fasting before surgery and the need to replenish with intra-venous fluids in children, evaluated with 3 measures of the aortic Integral Time Velocity with transthoracic echocardiography.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Erasme Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged between 3 and 6 years with a normal ponderal evolution.
  • Children with good general status (ASA 1)
  • Children whose parents have given the informed authorization to do the study.
  • Children seen in the consultation of anesthesiology.
  • Children programed to have ambulatory surgery (Amygdalectomy, dental care, dental extraction).

Exclusion Criteria:

  • Children with more than 6 years of age.
  • Children whose parents didn't agree with the study.
  • Children enrolled in another study on the 3 months before.
  • Children with hearth or lung conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patient
One-arm study, where all patients are given the same standard fluidotherapy and anesthetic conditions to compare measures of Aortic VTI before and after the IV fluid.
Other: Plasmalyte A Viaflo
Fluid therapy to be given according to the principle of 4-2-1 (4 ml of crystalloid fluid for each of the first 10 kg of weight (0-10 kg), 2 ml of crystalloid fluid for each of the second 10 kg of weight (11-20 kg) and 1 ml of crystalloid fluid for each kg of weight over 20.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aortic VTI change
Time Frame: From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).
Transthoracic echocardiography measures of the Time-Speed Interval in the aortic valve before fluid therapy (baseline) and after fluid therapy (20 ml/kg in 15 minutes).
From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure change
Time Frame: From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).
Analysis of the variation of Mean Arterial Blood pressure with fluid therapy
From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).
Legs-up maneuver
Time Frame: From baseline analysis (t=5 min after anesthesia induction), to the end of legs-up maneuver (t = +/- 10 min).
Analysis of the variation of Mean Arterial Blood pressure with the legs up maneuver
From baseline analysis (t=5 min after anesthesia induction), to the end of legs-up maneuver (t = +/- 10 min).
Post-operative nausea and vomiting
Time Frame: From arrival at PACU (end of surgery) until discharge from PACU (tipically after 1 to 2 hours after the arrival to the PACU)
Comparisson of the incidence of post-operative nausea and vomiting in the fluid respondeurs group vs non respondeurs.
From arrival at PACU (end of surgery) until discharge from PACU (tipically after 1 to 2 hours after the arrival to the PACU)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 15, 2018

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ErasmeVTI2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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