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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome, Adult
• Interventions: Device: Vivid S6 GE Ultrasound

• Registration Number: NCT02273687
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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).

Study Timeline

• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-24
• Study Start: 2014-10-29
• Primary Completion: 2017-09-29
• Study Completion: 2017-09-29
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prognostic study population	Vivid S6 GE Ultrasound	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

Primary Outcome Measures

Name	Time	Method
Measurement of diaphragmatic excursion by M-mode ultrasound	Day 0, baseline	in centimeters
Use of ventilation within the first 4 hours	Day 0, baseline + 4 hours	yes/no

Secondary Outcome Measures

Name	Time	Method
Measurement of diaphragmatic excursion by M-mode ultrasound	Day 0, baseline + 4 hours	in centimeters
Acute respiratory distress signs within the first 4 hours	Day 0, baseline + 4 hours	yes/no
Signs of respiratory re aggravation at 24 hours	Day 1	yes/no
Diagnosis	Day 1	qualitative variable: decompensated COPD, OAP, pneumonia, asthma, or pleural pathology

Trial Locations

Locations (2)

CH de Perpignan - Hôpital Saint Jean; 🇫🇷 Perpignan, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France