- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05341258
Arterial and End-Tidal CO2 Gradient as a Mortality Predictor in Critical Care Patients
August 22, 2022 updated by: Gaziosmanpasa Research and Education Hospital
Scoring systems (SOFA, APACHE-II etc.) are used to estimate the mortality rates of patients treated in the intensive care unit. .
In the scoring systems used, the disfunction level of the organs of the patients is measured.
Blood gas analysis is routinely performed in patients whom intubated in the intensive care unit and receiving mechanical ventilation support, and the patient's treatment is optimized according to the results of the examination.
The patient's mechanical ventilation settings are regulated by analyzing the Partial Arterial Carbondioxide (paCO2) value in the patient's blood gas result.
The difference between the paCO2 value in the blood gas and the End-tidal Carbondioxide (EtCO2) value measured in the mechanical ventilator is 3-5mmHg in normal healthy people, while this difference is seen more in critical care patients.
In critically ill patients in the intensive care unit, there is a greater increase in the difference between paCO2 and ETCO2 in cases where mortality is high, such as global perfusion disorder, shock situations, and massive pulmonary embolism, etc.
In this study, it was planned to investigate the use of the difference between the paCO2 value in the blood gas taken from the patient and the ETCO2 value measured in the mechanical ventilator to predict the mortality rate of the patient.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34255
- Gaziosmanpasa Training Research Hospital
-
-
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
Description
Inclusion Criteria:
- Critical Care Patients intubated in last 24 hours.
Exclusion Criteria:
- Patients younger than 18 years old.
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Critical Care Patients whom intubated last 24 hours
|
EtCO2
PaCO2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 6 months
|
Evaluation of correlation between PaCO2 and ETCO2 gradient difference and mortality in intubated critical care patients and mortality rates
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ICU Length of Stay
Time Frame: 6 months
|
Days patients treated at ICU
|
6 months
|
|
Ventilator Free Days
Time Frame: 6 months
|
Days during which the patient was mechanically ventilated
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Ulku Aygen Turkmen, Proffessor, Director of Anesthesiology and Reanimation Department
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)
January 1, 2022
Primary Completion (Actual)
August 1, 2022
Study Completion (Actual)
August 1, 2022
Study Registration Dates
First Submitted
April 17, 2022
First Submitted That Met QC Criteria
April 17, 2022
First Posted (Actual)
April 22, 2022
Study Record Updates
Last Update Posted (Actual)
August 24, 2022
Last Update Submitted That Met QC Criteria
August 22, 2022
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3751
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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