Clinical trial NCT03599973: Correlation Between Duration of Fasting and Response to Fluid Replenishment, Evaluated With Repeated Measures of VTI.
Official title: Corrélation Entre la Longueur de jeûne et la réponse au Remplissage Vasculaire évaluée Par Des Mesures répétées de l'ITV.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fluid and Electrolyte Imbalance
Fluid Therapy
Keywords: Rehydration Solutions
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Aortic VTI change
timeFrame: From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).
Secondary outcomes:
measure: Blood pressure change
timeFrame: From baseline analysis (t=5 min after anesthesia induction), to the end of fluid therapy (t=20 min).
measure: Legs-up maneuver
timeFrame: From baseline analysis (t=5 min after anesthesia induction), to the end of legs-up maneuver (t = +/- 10 min).
measure: Post-operative nausea and vomiting
timeFrame: From arrival at PACU (end of surgery) until discharge from PACU (tipically after 1 to 2 hours after the arrival to the PACU)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
Study officials:
References:
citation: Pees C, Glagau E, Hauser J, Michel-Behnke I. Reference values of aortic flow velocity integral in 1193 healthy infants, children, and adolescents to quickly estimate cardiac stroke volume. Pediatr Cardiol. 2013 Jun;34(5):1194-200. doi: 10.1007/s00246-012-0628-6. Epub 2013 Jan 24.
citation: Wang J, Xu E, Xiao Y. Isotonic versus hypotonic maintenance IV fluids in hospitalized children: a meta-analysis. Pediatrics. 2014 Jan;133(1):105-13. doi: 10.1542/peds.2013-2041. Epub 2013 Dec 30.
citation: Miller A, Mandeville J. Predicting and measuring fluid responsiveness with echocardiography. Echo Res Pract. 2016 Jun;3(2):G1-G12. doi: 10.1530/ERP-16-0008. Epub 2016 May 24.
citation: Mercado P, Maizel J, Beyls C, Titeca-Beauport D, Joris M, Kontar L, Riviere A, Bonef O, Soupison T, Tribouilloy C, de Cagny B, Slama M. Transthoracic echocardiography: an accurate and precise method for estimating cardiac output in the critically ill patient. Crit Care. 2017 Jun 9;21(1):136. doi: 10.1186/s13054-017-1737-7.
citation: Singh Y. Echocardiographic Evaluation of Hemodynamics in Neonates and Children. Front Pediatr. 2017 Sep 15;5:201. doi: 10.3389/fped.2017.00201. eCollection 2017.
citation: Lopez L, Colan SD, Frommelt PC, Ensing GJ, Kendall K, Younoszai AK, Lai WW, Geva T. Recommendations for quantification methods during the performance of a pediatric echocardiogram: a report from the Pediatric Measurements Writing Group of the American Society of Echocardiography Pediatric and Congenital Heart Disease Council. J Am Soc Echocardiogr. 2010 May;23(5):465-95; quiz 576-7. doi: 10.1016/j.echo.2010.03.019. No abstract available.
citation: Gaspar HA, Morhy SS. The Role of Focused Echocardiography in Pediatric Intensive Care: A Critical Appraisal. Biomed Res Int. 2015;2015:596451. doi: 10.1155/2015/596451. Epub 2015 Oct 28.
citation: Lai WW, Geva T, Shirali GS, Frommelt PC, Humes RA, Brook MM, Pignatelli RH, Rychik J; Task Force of the Pediatric Council of the American Society of Echocardiography; Pediatric Council of the American Society of Echocardiography. Guidelines and standards for performance of a pediatric echocardiogram: a report from the Task Force of the Pediatric Council of the American Society of Echocardiography. J Am Soc Echocardiogr. 2006 Dec;19(12):1413-30. doi: 10.1016/j.echo.2006.09.001. No abstract available.