Respiratory Distress Syndrome, Adult Clinical Trial
— EDDRAProOfficial title:
Analysis of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department: Predicting Respiratory Prognosis
Verified date | January 2018 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 104 |
Est. completion date | September 29, 2017 |
Est. primary completion date | September 29, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 09 | |
France | CH de Perpignan - Hôpital Saint Jean | Perpignan |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of diaphragmatic excursion by M-mode ultrasound | in centimeters | Day 0, baseline | |
Primary | Use of ventilation within the first 4 hours | yes/no | Day 0, baseline + 4 hours | |
Secondary | Measurement of diaphragmatic excursion by M-mode ultrasound | in centimeters | Day 0, baseline + 4 hours | |
Secondary | Acute respiratory distress signs within the first 4 hours | yes/no | Day 0, baseline + 4 hours | |
Secondary | Signs of respiratory re aggravation at 24 hours | yes/no | Day 1 | |
Secondary | Diagnosis | qualitative variable: decompensated COPD, OAP, pneumonia, asthma, or pleural pathology | Day 1 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03712215 -
STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT
|
N/A | |
Completed |
NCT04582201 -
Evaluate the Safety of agenT-797 in Participants With Moderate to Severe Difficulty Breathing Secondary to SARS-CoV-2
|
Phase 1/Phase 2 | |
Recruiting |
NCT01990456 -
Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study
|
N/A | |
Completed |
NCT01167621 -
Changes in Refractory Acute Respiratory Distress Syndrome (ARDS) Patients Under High Frequency Oscillation-ventilation
|
N/A | |
Terminated |
NCT00233207 -
IC14 Antibodies to Treat Individuals With Acute Lung Injury
|
Phase 2 | |
Completed |
NCT00029328 -
Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
|
Phase 1/Phase 2 | |
Completed |
NCT00004494 -
Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
|
Phase 1 | |
Completed |
NCT00000579 -
Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)
|
Phase 3 | |
Recruiting |
NCT03236272 -
Establishment of a Biomarkers-based Early Warning System of Acute Respiratory Distress Syndrome (ARDS)
|
||
Withdrawn |
NCT04508933 -
Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients
|
||
Recruiting |
NCT03424798 -
Measuring Heart and Lung Function in Critical Care
|
N/A | |
Recruiting |
NCT01992237 -
Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients
|
N/A | |
Completed |
NCT00719446 -
Evaluating Health Outcomes and QOL After ALI Among Participants of the ALTA, OMEGA, EDEN, and SAILS ARDS Network Trials
|
N/A | |
Completed |
NCT00236262 -
Effect of Positive Expiratory Pressure on Right Ventricular Function in Patients With Respiratory Distress Syndrome
|
N/A | |
Completed |
NCT00300248 -
Long-Term Results in Mechanically Ventilated Individuals With Acute Lung Injury/Acute Respiratory Distress Syndrome
|
N/A | |
Completed |
NCT00157144 -
Australia and New Zealand Adult Extracorporeal Membrane Oxygenation (ECMO) Audit 2005
|
N/A | |
Completed |
NCT00141726 -
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
|
Phase 2 | |
Recruiting |
NCT00465374 -
A Validation/Interventional Study on Stress Index in Predicting Mechanical Stress in ARDS Patients
|
Phase 3 | |
Completed |
NCT00094406 -
Carbon Monoxide to Prevent Lung Inflammation
|
Phase 1 | |
Recruiting |
NCT03709199 -
Long Term Follow up of Children Enrolled in the REDvent Study
|