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

Not Applicable

• Conditions: Fluid and Electrolyte Imbalance; Fluid Therapy
• Interventions: Other: Plasmalyte A Viaflo

• Registration Number: NCT03599973
• Lead Sponsor: Erasme University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-13
• Status Verified: 2018-06
• Study First Submitted QC: 2018-07-24
• Last Update Submitted: 2018-07-24
• Study First Posted: 2018-07-26
• Last Update Posted: 2018-07-26
• Study Start: 2018-08-15
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient	Plasmalyte A Viaflo	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.

Primary Outcome Measures

Name	Time	Method
Aortic VTI change	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 Outcome Measures

Name	Time	Method
Blood pressure change	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
Legs-up maneuver	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
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)	Comparisson of the incidence of post-operative nausea and vomiting in the fluid respondeurs group vs non respondeurs.

Trial Locations

Locations (1)

Erasme Hospital; 🇧🇪 Brussels, Belgium