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

Primary Purpose

Acute Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
check-list including lung ultrasound
Sponsored by
Centre Hospitalier Metropole Savoie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Respiratory Failure focused on measuring Covid19, Acute Respiratory Failure, Ultrasound, Checklist, Emergency, Diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH Annecy Genevois
  • Centre Hospitalier Metropole Savoie
  • CHUGA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

check-list with ultrasound

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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).
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)

Full Information

First Posted
February 22, 2021
Last Updated
June 20, 2022
Sponsor
Centre Hospitalier Metropole Savoie
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1. Study Identification

Unique Protocol Identification Number
NCT04791241
Brief Title
A Check-list Including Lung Ultrasound for ED Patients With ARF
Acronym
CHECKIRA-COVID
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
January 3, 2022 (Actual)
Study Completion Date
January 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Metropole Savoie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
Covid19, Acute Respiratory Failure, Ultrasound, Checklist, Emergency, Diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
check-list with ultrasound
Arm Type
Experimental
Arm Description
check-list including lung ultrasound for the management of patients with acute respiratory failure at the emergency department during the COVID-19 era
Intervention Type
Other
Intervention Name(s)
check-list including lung ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Agreement between the etiology retained after using the checklist and the diagnosis retained by an adjudication committee after analysis of the entire patient file.
Description
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.
Time Frame
1 month after inclusion
Secondary Outcome Measure Information:
Title
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
Description
The adjudication committee will meet periodically after analysis of the complete anonymized file to check the COVID diagnosis.
Time Frame
One month after inclusion
Title
Collection of treatments started only after completion of the checklist and verification of its suitability for the diagnosis selected
Description
All the treatments started only after completion of the checklist wil be collected prospectively and their appropriateness will be checked.
Time Frame
at one day
Title
Collection of additional examinations possibly performed in the emergency unit after the completion of the checklist
Description
All additional examinations performed after the completion of the checklist will be collected
Time Frame
at one day
Title
Comparison of treatments introduced after completion of the checklist and after the other additional examinations performed at the emergency room
Description
all treatments delivered after the completion of the checklist and after complementary exams will be collected and classified into therapeutic families (antibiotics, diuretics).
Time Frame
at one day
Title
Delay between completion of the checklist and obtaining the results of any other examinations
Description
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)
Time Frame
At one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CH Annecy Genevois
City
Annecy
ZIP/Postal Code
74370
Country
France
Facility Name
Centre Hospitalier Metropole Savoie
City
Chambéry
ZIP/Postal Code
73000
Country
France
Facility Name
CHUGA
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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