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Hypercapnic Acute Respiratory Failure in the ICU : the YETI Study (YETI)

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ClinicalTrials.gov Identifier: NCT04304339
Recruitment Status : Suspended (Covid19 pandemia)
First Posted : March 11, 2020
Last Update Posted : November 19, 2020
Sponsor:
Collaborator:
Castor
Information provided by (Responsible Party):
French Society for Intensive Care

Brief Summary:

Hypercapnia is a frequent clinical situation defined as an elevation of the partial pressure of carbon dioxide (PaCO2) above 45 mmHg. Several physiopathological parameters such as respiratory minute volume, dead space volume or CO2 production influence the PaCO2. Therefore, hypercapnia can affect the time of various diseases.

Available epidemiological data regarding hypercapnia are from studies investigating the efficacy of non-invasive ventilation (NIV), with different population cohorts. However, their interpretation must be cautious given the heterogeneity in patient case-mix and results.

Then, whether hypercapnia is a common reason for intensive care unit (ICU) admission, epidemiological data is scarce and heterogeneous. The aim of this study is to investigate the epidemiological, clinical determinants and outcomes of patients admitted to ICU with hypercapnic respiratory failure.


Condition or disease Intervention/treatment
Intensive Care Unit Syndrome Hypercapnia Acute Respiratory Failure Other: Hypercapnic respiratory failure

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hypercapnic Acute Respiratory Failure in the ICU : the YETI Study
Actual Study Start Date : September 22, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : November 1, 2021



Intervention Details:
  • Other: Hypercapnic respiratory failure
    Patients with hypercapnic respiratory failure will be followed without any additional intervention


Primary Outcome Measures :
  1. Prevalence of hypercapnic acute respiratory failure in ICU [ Time Frame: Intensive Care Unit length stay (Usually 7 days) ]
    Number of patients with hypercapnic acute respiratory failure in ICU related to number of patients admitted in the ICU during study period



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The aim of this study is to investigate the epidemiological, clinical determinants and outcomes of patients admitted to ICU with hypercapnic respiratory failure.
Criteria

Inclusion Criteria:

  • patients ≥18 years old presenting with at least of the following items :

    1. respiratory rate ≥ 25/min,
    2. paradoxical motion of the abdomen,
    3. intercostal retraction AND
  • a PaCO2 > 45 cm H20 before ICU admission or within the 12 hours following ICU admission.

Exclusion Criteria:

  • Refusal to give informed consent,
  • pregnancy,
  • < 18 years patient,
  • dying patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304339


Locations
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France
CH Andre Migniot
Versailles, A, France
CHU Nantes
Nantes, France
CHU Toulouse
Toulouse, France
Sponsors and Collaborators
French Society for Intensive Care
Castor
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Responsible Party: French Society for Intensive Care
ClinicalTrials.gov Identifier: NCT04304339    
Other Study ID Numbers: YETI
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Signs and Symptoms, Respiratory