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Completed

NCT Number: NCT04791241

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

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.

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Key information

Conditions

Acute Respiratory Failure COVID-19 Coronaviridae Infections Coronavirus Infections Disease Disease Attributes Emergencies Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Annecy Genevois, Annecy, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    Time frame: 1 month after inclusion

    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 outcomes

  1. 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

    Time frame: One month after inclusion

    The adjudication committee will meet periodically after analysis of the complete anonymized file to check the COVID diagnosis.

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

    Time frame: at one day

    All the treatments started only after completion of the checklist wil be collected prospectively and their appropriateness will be checked.

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

    Time frame: at one day

    All additional examinations performed after the completion of the checklist will be collected

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

    Time frame: at one day

    all treatments delivered after the completion of the checklist and after complementary exams will be collected and classified into therapeutic families (antibiotics, diuretics).

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

    Time frame: At one day

    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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Metropole Savoie

Other

Registry information

Official study 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

Acronym: CHECKIRA-COVID

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2021
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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