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Reproductibility of TM-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the ER

Reproductibility of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the Emergency Room

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01743105
Acronym
EDDRA-Repro
Enrollment
26
Registered
2012-12-06
Start date
2013-08-31
Completion date
2014-01-27
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Adult

Keywords

diaphragm movement, ultrasound, emergency room

Brief summary

The main objective of this study is to evaluate the inter-rater reproducibility of diaphragmatic excursion measures via time-motion-mode ultrasound (evaluation performed on the first measure) in patients experiencing acute respiratory distress emergencies.

Detailed description

The secondary objectives of this study are: * To assess the feasibility of measuring the diaphragmatic excursion in the context of emergency management (ratio of measured patients / included patients). * To evaluate the time required for the measurement. * To assess the intra-rater reproducibility of measurements of diaphragmatic excursion (comparison of first and second measures).

Interventions

PROCEDUREDiaphragm excursion measures 1

A first diaphragm ultrasound study will be carried out by investigator 1. A Vivid S6 GE Ultrasound will be used, with a phased array cardiac probe.

PROCEDUREDiaphragm excursion measures 2

A second diaphragm ultrasound study will be carried out immediately after Ultrasound 1, and by investigator 2. The results are blinded between investigators. A Vivid S6 GE Ultrasound will be used, with a phased array cardiac probe.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient has acute respiratory distress defined by a respiratory rate \> 25, and / or signs of struggle and hypoxia, oxygen saturation (SpO2) \<90% and / or pH \<7.35 and carbon dioxide partial pressure (pCO2) \> 6 kPa (45 mm Hg) * The patient breathes spontaneously (no respirator)

Exclusion criteria

* The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient or his/her representative refuses to sign the consent * It is impossible to correctly inform the patient, or to correctly inform his/her representative * The patient is pregnant, parturient, or breastfeeding * The patient has a neurological or neuromuscular disease that modifies diaphragm function/movement; this does not include cases of decompensation (polyradiculoneuropathy, Lou Gehrig's disease, Myasthenia ...). * Patient admitted with respiratory support treatment in progress * Patient admitted with respiratory failure requiring immediate implementation of mechanical ventilation, thus preventing ultrasound measurements

Design outcomes

Primary

MeasureTime frameDescription
Diaphragmatic excursion, first measure by investigator 1Baseline (day 0)in centimeters
Diaphragmatic excursion, first measure by investigator 2Baseline (day 0)in centimeters

Secondary

MeasureTime frameDescription
Feasibility (yes/no)Baseline (day 0)We were able to perform the required measurements (yes/no)
Diaphragmatic excursion, second measure by investigator 2Baseline (day 0)(centimeters)
Diaphragmatic excursion, second measure by investigator 1Baseline (day 0)(centimeters)
Time necessary to measure diaphragm movement amplitude (minutes)Baseline (day 0)

Other

MeasureTime frame
AgeBaseline (day 0)
SexeBaseline (day 0)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026