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Fluid Responsiveness Evaluation by a Non-invasive Method in CHildren

NCT05919719 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2023-06-26

No results posted yet for this study

Summary

In this study, the investigators aim to validate a non-invasive marker of fluid-responsiveness in children with acute circulatory failure based on standardized abdominal compression. This would allow physicians to identify which patient could benefit from a fluid expansion, thus avoiding a potentially useless or even dangerous fluid expansion, leading to fluid overload. To this end, the investigators will evaluate the diagnostic accuracy (sensitivity and specificity) of stroke volume variation induced by standardized abdominal compression for the diagnosis of fluid responsiveness (based on the gold-standard test: significant increase in cardiac index after fluid expansion).

Conditions

  • Circulatory Failure (Shock)

Interventions

PROCEDURE

Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment).

Fluid expansion will be delayed while our index test is performed. After fluid expansion, patient will undergo an echocardiographic assessment of response to fluid expansion (gold-standard). Our index test is the ΔSVi-AC: indexed percentage of stroke volume variation between baseline and during a standardized abdominal compression. Stroke volume will be assessed by transthoracic echocardiography. Patient will undergo 3 echocardiographic assessment: At baseline, During abdominal compression, After the 10 to 20ml/kg crystalloid fluid expansion Abdominal compression : a sphygmomanometer will be inflated to a pressure of less than 10 mmHg and will be applied to the center of the patient's abdomen. Then, a gentle compression on the sphygmomanometer will be performed, calibrated at 22 - 26 mmHg according to the sphygmomanometer. The echocardiographic assessments will take place between 10 and 60 seconds after the start of the compression, which will therefore last less than a minute.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Julien GOTCHAC, MD · Bordeaux hospital University

Eligibility

Min Age
1 Minute
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-03
Primary Completion
2023-02-01
Completion
2023-02-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05919719 on ClinicalTrials.gov