A Check-list Including Lung Ultrasound for ED Patients With ARF

NCT04791241 | Completed

• 1 other identifier: CHMS20005
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of the study is to evaluate if a check-list including lung ultrasonography can help to identify the etiology of the acute respiratory failure of patients managed at the emergency room. Adult patients admitted to the emergency room for acute respiratory failure will be offered the study. The emergency physician will perform a systematic examination using a checklist, including pulmonary embolism prediction scores, structured clinical examination and lung ultrasound, in order to establish a diagnostic hypothesis. A diagnostic hypothesis will be made after completion of the checklist. The emergency physician can perform additional examinations and treatment after completion of the checklist. The final diagnosis will be checked by an adjudication committee which will have all the documents established during the emergency room consultation and any hospitalization following this hospitalization. The main outcome will be the concordance rate between the diagnosis after the check-list and the final diagnosis.

Conditions

Acute Respiratory Failure

Keywords

Covid19; Acute Respiratory Failure; Ultrasound; Checklist; Emergency; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Agreement between the etiology retained after using the checklist and the diagnosis retained by an adjudication committee after analysis of the entire patient file.

  The adjudication committee will meet all 35 inclusions to determine the diagnosis of each patient after analysis of the complete anonymized file which will be provided by locol investigator one month after inclusion.

  1 month after inclusion

Secondary Outcomes (5)

• Analysis of the diagnosis retained after the checklist in patients with a final diagnosis of COVID-19; analysis of the final diagnosis in patients with a diagnosis of COVID-19 evoked after the checklist

  One month after inclusion

• Collection of treatments started only after completion of the checklist and verification of its suitability for the diagnosis selected

  at one day

• Collection of additional examinations possibly performed in the emergency unit after the completion of the checklist

  at one day

• Comparison of treatments introduced after completion of the checklist and after the other additional examinations performed at the emergency room

  at one day

• Delay between completion of the checklist and obtaining the results of any other examinations

  At one day

Study Arms (1)

check-list with ultrasound

EXPERIMENTAL

check-list including lung ultrasound for the management of patients with acute respiratory failure at the emergency department during the COVID-19 era

Other: check-list including lung ultrasound

Interventions

check-list including lung ultrasound OTHER

The investigator will follow the checklist which includes the collection of anamnestic data and clinical signs, the performance of a pulmonary embolism clinical probability score and a cardiopulmonary ultrasound with count -standardized rendering. After completing this checklist, the investigator will note their diagnosis (list of proposals on the data collection sheet), the treatments started (closed list of therapeutic classes). If he orders other tests, he will write them down and then note the diagnosis made and the treatments prescribed after obtaining the results of these tests. The therapeutic management of patients compared to the usual care in the respective departments may be modified depending on the results of the cardiopulmonary ultrasound . The emergency physician may initiate therapy before the results of additional examinations that he would have usually performed without cardiopulmonary ultrasound.

check-list with ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with acute respiratory failure table (SpO2 90% in ambient air or need more than 3 L/min of oxygen to have SpO2 \> 92% AND/OR signs of respiratory struggle sign AND/OR respiratory rate control \> 25 cycles/minute AND/OR cyanosis)
• Over 18 years old

You may not qualify if:

• Pregnant, Parturising or Breastfeeding Women
• Patient who has already participated in the study in the previous 7 days

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead

Study Sites (3)

CH Annecy Genevois

Annecy, 74370, France

Location

Centre Hospitalier Metropole Savoie

Chambéry, 73000, France

Location

CHUGA

Grenoble, 38000, France

Location

MeSH Terms

Conditions

COVID-19; Emergencies; Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 10, 2021
• Study Start: March 3, 2021
• Primary Completion: January 3, 2022
• Study Completion: January 4, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)