NCT04304339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
862

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 14, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2022

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

March 9, 2020

Last Update Submit

September 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of hypercapnic acute respiratory failure in ICU

    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)

Interventions

Patients with hypercapnic respiratory failure will be followed without any additional intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • patients ≥18 years old presenting with at least of the following items :
  • respiratory rate ≥ 25/min,
  • paradoxical motion of the abdomen,
  • intercostal retraction AND
  • a PaCO2 \> 45 cm H20 before ICU admission or within the 12 hours following ICU admission.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CH Andre Migniot

Versailles, A, France

Location

CHU Nantes

Nantes, France

Location

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Hypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 11, 2020

Study Start

December 14, 2021

Primary Completion

July 13, 2022

Study Completion

July 13, 2022

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations