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

December 15, 2021 updated by: French Society for Intensive Care

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jean Francois Llitjos, MD
  • Phone Number: +33 1 45 86 74 00
  • Email: jllitjos@gmail.com

Study Contact Backup

Study Locations

  • France
      • Nantes, France
        • Recruiting
        • CHU Nantes
        • Contact:
          • Mélaine Le Brazic
      • Toulouse, France
        • Recruiting
        • CHU Toulouse
        • Contact:
          • Guillaume Decormeille
    • A
      • Versailles, A, France
        • Recruiting
        • CH Andre Migniot
        • Contact:
          • Gwenaelle Jacq

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Intensive Care Unit length stay (Usually 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Society for Intensive Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2021

Primary Completion (Anticipated)

December 14, 2022

Study Completion (Anticipated)

January 14, 2023

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

January 6, 2022

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YETI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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