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Pediatric Diaphragm Thickness Trial

NCT04882553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-01-24

No results posted yet for this study

Summary

The evaluation of diaphragm function in ventilated patients is not easy. One option is to use esophageal pressure (Pes) measurements but recently, diaphragmatic ultrasound has proven itself as a useful tool in this setting. In adults the thickening fraction (TF), which describes the difference in thickness between end-inspiration and end-expiration, correlates with the diaphragmatic pressure-time product per breath (PTPdi), an esophageal pressure-derived work of breathing parameter. There is a lack of data that tells us whether the same is true in children. This physiological study intends to look at the correlation between esophageal pressures and thickening fraction assessed by ultrasound in a pediatric cohort of patients.

Conditions

  • Child

Interventions

PROCEDURE

Diaphragmatic echography

Echography of the diaphragm at the zone of apposition. End-inspiratory and/or end-expiratory thickness of the diaphragm will be measured in M-mode.

PROCEDURE

Measurement of esophageal pressure

Pressure will be measured in the lower third of the esophagus using an esophageal balloon and pressure transducer.

DIAGNOSTIC_TEST

Registration of respiratory mechanics

Pressures and volumes will be registered by the Fluxmed respiratory monitor (MBMED, Argentina)

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Tom Schepens, MD · University Hospital, Antwerp

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
28 Days
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-11
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • Belgium

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 NCT04882553 on ClinicalTrials.gov