Back to resultsArterial and End-Tidal CO2 Gradient as a Mortality Predictor in Critical Care Patients
Primary Purpose
Critical Illness, Ventilation Perfusion Mismatch, Shock
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
EtCO2
PaCO2
Sponsored by
About this trial
This is an interventional diagnostic trial for Critical Illness
Eligibility Criteria
Inclusion Criteria:
- Critical Care Patients intubated in last 24 hours.
Exclusion Criteria:
- Patients younger than 18 years old.
Sites / Locations
- Gaziosmanpasa Training Research Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Critical Care Patients whom intubated last 24 hours
Arm Description
Critical Care Patients whom intubated last 24 hours
Outcomes
Primary Outcome Measures
Mortality
Evaluation of correlation between PaCO2 and ETCO2 gradient difference and mortality in intubated critical care patients and mortality rates
Secondary Outcome Measures
ICU Length of Stay
Days patients treated at ICU
Ventilator Free Days
Days during which the patient was mechanically ventilated
Full Information
NCT ID
NCT05341258
First Posted
April 17, 2022
Last Updated
August 22, 2022
Sponsor
Gaziosmanpasa Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05341258
Brief Title
Arterial and End-Tidal CO2 Gradient as a Mortality Predictor in Critical Care Patients
Official Title
Arterial and End-Tidal CO2 Gradient as a Mortality Predictor in Critical Care Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Ventilation Perfusion Mismatch, Shock, Pulmonary Embolism, Trauma, Copd
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Critical Care Patients whom intubated last 24 hours
Arm Type
Other
Arm Description
Critical Care Patients whom intubated last 24 hours
Intervention Type
Diagnostic Test
Intervention Name(s)
EtCO2
Intervention Description
EtCO2
Intervention Type
Diagnostic Test
Intervention Name(s)
PaCO2
Intervention Description
PaCO2
Primary Outcome Measure Information:
Title
Mortality
Description
Evaluation of correlation between PaCO2 and ETCO2 gradient difference and mortality in intubated critical care patients and mortality rates
Time Frame
6 months
Secondary Outcome Measure Information:
Title
ICU Length of Stay
Description
Days patients treated at ICU
Time Frame
6 months
Title
Ventilator Free Days
Description
Days during which the patient was mechanically ventilated
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Critical Care Patients intubated in last 24 hours.
Exclusion Criteria:
Patients younger than 18 years old.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulku Aygen Turkmen, Proffessor
Organizational Affiliation
Director of Anesthesiology and Reanimation Department
Official's Role
Study Director
Facility Information:
Facility Name
Gaziosmanpasa Training Research Hospital
City
Istanbul
ZIP/Postal Code
34255
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Arterial and End-Tidal CO2 Gradient as a Mortality Predictor in Critical Care Patients
We'll reach out to this number within 24 hrs