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Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department (EDDRAPro)

Primary Purpose

Respiratory Distress Syndrome, Adult

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Vivid S6 GE Ultrasound

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 has given informed consent (and signed the consent form) or, in case of an emergency situation, an investigator has committed to obtaining the consent of the patient as soon as his/her condition permits
Patient affiliated with or beneficiary of a health insurance plan
Acute Respiratory Distress (DRA) defined by: (1) respiratory rate > 25 and/or signs of struggle and hypoxia AND (2) SpO2 values < 90% and/or [pH < 7.35 and pCO2 > 6 kPa (45 mm Hg)]
Breathing spontaneously (no ventilation)

Exclusion Criteria:

Patient currently participating in or having participated in another interventional study in the previous three months, or patient in an exclusion period determined by a previous study
Patient under judicial protection or any kind of guardianship
Refusal to sign the consent
Patient pregnant, parturient, or lactating
Neurological or neuromuscular disease modifying the operation of the diaphragm without any decompensation (Polyneuropathy, Lou Gehrig's disease, Myasthenia ...)
Patient who received mechanical ventilation at home
Patient who received treatment by mechanical ventilation during the pre-hospitalization care phase
Patient admitted with respiratory failure requiring immediate installation of a mechanical ventilation and thus not allowing the performance of two ultrasound measurements
Patient suffering from a pneumothorax

Sites / Locations

CHRU de Nîmes - Hôpital Universitaire Carémeau
CH de Perpignan - Hôpital Saint Jean

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prognostic 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. Intervention: Diaphragmatic ultrasound

Outcomes

Primary Outcome Measures

Measurement of diaphragmatic excursion by M-mode ultrasound

in centimeters

Use of ventilation within the first 4 hours

yes/no

Secondary Outcome Measures

Measurement of diaphragmatic excursion by M-mode ultrasound

in centimeters

Acute respiratory distress signs within the first 4 hours

yes/no

Signs of respiratory re aggravation at 24 hours

yes/no

Diagnosis

qualitative variable: decompensated COPD, OAP, pneumonia, asthma, or pleural pathology

Full Information

NCT ID

NCT02273687

First Posted

October 22, 2014

Last Updated

January 2, 2018

Sponsor

Centre Hospitalier Universitaire de Nīmes

1. Study Identification

Unique Protocol Identification Number

NCT02273687

Brief Title

Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department

Acronym

EDDRAPro

Official Title

Analysis of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department: Predicting Respiratory Prognosis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

October 29, 2014 (Actual)

Primary Completion Date

September 29, 2017 (Actual)

Study Completion Date

September 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main objective of this study is to show that "diaphragmatic excursion measures upon emergency admission" (CDA values) on patients with acute respiratory failure are predictive of the need to use mechanical ventilation (invasive or non-) in the first four hours.

Detailed Description

The secondary objectives of this study are: A-determine a prognostic threshold for diaphragmatic excursion measures able to predict the use of mechanical ventilation (invasive or not) in the first four hours. B-to study the association between CDA values and persistence of respiratory distress during the first 4 hours of care among patients who, at 4 hours, are not mechanically ventilated. C-to study the association between CDA values and respiratory re-exacerbation or a continuing need for mechanical ventilation during the 24 first hours after admission to the emergency room D-to study the association between diaphragmatic excursion measures made after initial emergency care (at 4 hours; =CDH4), and the persistence of respiratory distress at 4 hours, in patients who at 4 hours are not mechanically ventilated. E-to study the association between CDH4 values and respiratory re-exacerbation during the 24 first hours after admission to the emergency room among patients who, at 4 hours, are not mechanically ventilated F-to study the association between changes in values of diaphragmatic excursion measure before and after initial emergency care (CDA → CDH4) and respiratory re-exacerbation during the 24 first hours after admission to the emergency room among patients who, at 4 hours, are not mechanically ventilated. G-analyze patient outcomes by subgroup according to diagnosis (decompensated COPD, OAP, lung disease, asthma, pleural disease).

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

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prognostic study population

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Vivid S6 GE Ultrasound

Intervention Description

Diaphragmatic ultrasound will be performed by the physician supporting the patient on arrival and also at 4 hours later in the beginning of therapeutic management. The patient will be monitored for 24 hours following inclusion. The exams will all be done with the same ultrasound system (Vivid S6 GE Ultrasound) and a phased array probe, also called a cardiac probe.

Primary Outcome Measure Information:

Title

Measurement of diaphragmatic excursion by M-mode ultrasound

Description

in centimeters

Time Frame

Day 0, baseline

Title

Use of ventilation within the first 4 hours

Description

yes/no

Time Frame

Day 0, baseline + 4 hours

Secondary Outcome Measure Information:

Title

Measurement of diaphragmatic excursion by M-mode ultrasound

Description

in centimeters

Time Frame

Day 0, baseline + 4 hours

Title

Acute respiratory distress signs within the first 4 hours

Description

yes/no

Time Frame

Day 0, baseline + 4 hours

Title

Signs of respiratory re aggravation at 24 hours

Description

yes/no

Time Frame

Day 1

Title

Diagnosis

Description

qualitative variable: decompensated COPD, OAP, pneumonia, asthma, or pleural pathology

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient has given informed consent (and signed the consent form) or, in case of an emergency situation, an investigator has committed to obtaining the consent of the patient as soon as his/her condition permits Patient affiliated with or beneficiary of a health insurance plan Acute Respiratory Distress (DRA) defined by: (1) respiratory rate > 25 and/or signs of struggle and hypoxia AND (2) SpO2 values < 90% and/or [pH < 7.35 and pCO2 > 6 kPa (45 mm Hg)] Breathing spontaneously (no ventilation) Exclusion Criteria: Patient currently participating in or having participated in another interventional study in the previous three months, or patient in an exclusion period determined by a previous study Patient under judicial protection or any kind of guardianship Refusal to sign the consent Patient pregnant, parturient, or lactating Neurological or neuromuscular disease modifying the operation of the diaphragm without any decompensation (Polyneuropathy, Lou Gehrig's disease, Myasthenia ...) Patient who received mechanical ventilation at home Patient who received treatment by mechanical ventilation during the pre-hospitalization care phase Patient admitted with respiratory failure requiring immediate installation of a mechanical ventilation and thus not allowing the performance of two ultrasound measurements Patient suffering from a pneumothorax

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

CHRU de Nîmes - Hôpital Universitaire Carémeau

City

Nîmes Cedex 09

ZIP/Postal Code

30029

Country

France

Facility Name

CH de Perpignan - Hôpital Saint Jean

City

Perpignan

ZIP/Postal Code

66046

Country

France

12. IPD Sharing Statement

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Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department

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