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

Primary Purpose

Respiratory Distress Syndrome, Adult

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diaphragm excursion measures 1
Diaphragm excursion measures 2
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiratory Distress Syndrome, Adult focused on measuring diaphragm movement, ultrasound, emergency room

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study population

Arm Description

The study population consists of patients treated for acute respiratory distress in the emergency department at the Nîmes University Hospital. See inclusion and exclusion criteria. Interventions: Diaphragm excursion measures 1, Diaphragm excursion measures 2

Outcomes

Primary Outcome Measures

Diaphragmatic excursion, first measure by investigator 1
in centimeters
Diaphragmatic excursion, first measure by investigator 2
in centimeters

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2012
Last Updated
March 25, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01743105
Brief Title
Reproductibility of TM-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the ER
Acronym
EDDRA-Repro
Official Title
Reproductibility of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the Emergency Room
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Adult
Keywords
diaphragm movement, ultrasound, emergency room

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study population
Arm Type
Experimental
Arm Description
The study population consists of patients treated for acute respiratory distress in the emergency department at the Nîmes University Hospital. See inclusion and exclusion criteria. Interventions: Diaphragm excursion measures 1, Diaphragm excursion measures 2
Intervention Type
Procedure
Intervention Name(s)
Diaphragm excursion measures 1
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Diaphragm excursion measures 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diaphragmatic excursion, first measure by investigator 1
Description
in centimeters
Time Frame
Baseline (day 0)
Title
Diaphragmatic excursion, first measure by investigator 2
Description
in centimeters
Time Frame
Baseline (day 0)
Secondary Outcome Measure Information:
Title
Time necessary to measure diaphragm movement amplitude (minutes)
Time Frame
Baseline (day 0)
Title
Feasibility (yes/no)
Description
We were able to perform the required measurements (yes/no)
Time Frame
Baseline (day 0)
Title
Diaphragmatic excursion, second measure by investigator 1
Description
(centimeters)
Time Frame
Baseline (day 0)
Title
Diaphragmatic excursion, second measure by investigator 2
Description
(centimeters)
Time Frame
Baseline (day 0)
Other Pre-specified Outcome Measures:
Title
Age
Time Frame
Baseline (day 0)
Title
Sexe
Time Frame
Baseline (day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Bobbia, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
State/Province
Gard
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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