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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03599973
Other study ID # ErasmeVTI2018
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 15, 2018
Est. completion date July 1, 2019

Study information

Verified date June 2018
Source Erasme University Hospital
Contact Ionut Tabolcea, MD
Phone 0032488720046
Email ionutztb@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date July 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 6 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Belgium Erasme Hospital Brussels

Sponsors (1)

Lead Sponsor Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (8)

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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Aortic VTI change 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 Blood pressure change 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).
Secondary Legs-up maneuver 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).
Secondary Post-operative nausea and vomiting 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)
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