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

Respiratory Distress Syndrome, Adult Clinical Trial

— EDDRAPro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273687
• Other study ID #: LOCAL/20143/XBAC-01
• Secondary ID: 2014-A00511-46
• Status: Completed
• Phase: N/A
• First received: October 22, 2014
• Last updated: January 2, 2018
• Start date: October 29, 2014
• Est. completion date: September 29, 2017

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Lung Injury
• Emergencies
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Vivid S6 GE Ultrasound
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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09
France	CH de Perpignan - Hôpital Saint Jean	Perpignan

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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