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Clinical Trials/NCT03599973
NCT03599973UnknownNot Applicable

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

Erasme University Hospital1 site in 1 country30 target enrollmentStarted: August 15, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Aortic VTI change

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
2 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Patient

Other

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.

Intervention: Plasmalyte A Viaflo (Other)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Blood pressure change(From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).)
  • 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(From arrival at PACU (end of surgery) until discharge from PACU (tipically after 1 to 2 hours after the arrival to the PACU))

Investigators

Sponsor
Erasme University Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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