A Check-list Including Lung Ultrasound for ED Patients With ARF (CHECKIRA-COVID)

Evaluation of a Check-list Including Lung Ultrasound for the Management of Patients With Acute Respiratory Failure at the Emergency Department During the COVID-19 Era

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Other: check-list including lung ultrasound

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Annecy, France, 74370
    • CH Annecy Genevois
  • Chambéry, France, 73000
    • Centre Hospitalier Métropole Savoie
  • Grenoble, France, 38000
    • CHUGA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: check-list with ultrasound; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The adjudication committee will meet periodically after analysis of the complete anonymized file to check the COVID diagnosis.	One month after inclusion
Collection of treatments started only after completion of the checklist and verification of its suitability for the diagnosis selected	All the treatments started only after completion of the checklist wil be collected prospectively and their appropriateness will be checked.	at one day
Collection of additional examinations possibly performed in the emergency unit after the completion of the checklist	All additional examinations performed after the completion of the checklist will be collected	at one day
Comparison of treatments introduced after completion of the checklist and after the other additional examinations performed at the emergency room	all treatments delivered after the completion of the checklist and after complementary exams will be collected and classified into therapeutic families (antibiotics, diuretics).	at one day
Delay between completion of the checklist and obtaining the results of any other examinations	Time between the completion of the checklist and obtaining the last result of the other examinations performed at the emergency room (except for bacterial culture)	At one day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Metropole Savoie

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): January 3, 2022
• Study Completion (Actual): January 4, 2022

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasound; Covid19; Diagnosis; Emergency; Acute Respiratory Failure; Checklist
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: CHMS20005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No