Arterial and End-Tidal CO2 Gradient as a Mortality Predic... | NCT05341258

Studies
Arterial and End-Tidal CO2 Gradient as a Mortality Predictor in Critical Care Patients

NCT05341258

Sponsor

Gaziosmanpasa Research and Education Hospital

Status

Completed

Last Update Posted

Aug 24, 2022Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Critical Illness
Ventilation Perfusion Mismatch
Shock
Pulmonary Embolism
Trauma
Copd

Interventions

EtCO2
PaCO2

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Aug 1, 2022Actual

Completion Date

Aug 1, 2022Actual

First Submitted Date

Apr 17, 2022

First Submission Date that Met QC Criteria

Apr 17, 2022

First Posted Date

Apr 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2022

Last Update Posted Date

Aug 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Critical Care Patients whom intubated last 24 hours	Other	Critical Care Patients whom intubated last 24 hours	Diagnostic Test: EtCO2 Diagnostic Test: PaCO2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EtCO2	Diagnostic Test	EtCO2	Critical Care Patients whom intubated last 24 hours

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Evaluation of correlation between PaCO2 and ETCO2 gradient difference and mortality in intubated critical care patients and mortality rates	6 months

Secondary Outcomes

Measure	Description	Time Frame
ICU Length of Stay	Days patients treated at ICU	6 months
Ventilator Free Days	Days during which the patient was mechanically ventilated

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Critical Care Patients intubated in last 24 hours.

Exclusion Criteria:

Patients younger than 18 years old.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulku Aygen Turkmen, Proffessor	Director of Anesthesiology and Reanimation Department	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziosmanpasa Training Research Hospital		Istanbul		34255	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41862829	Derived	Ozakin O, Turkmen UA. Arterial and end-tidal CO2 gradient as a mortality predictor in critical care patients: a prospective observational study. BMC Anesthesiol. 2026 Mar 21;26(1):271. doi: 10.1186/s12871-026-03784-1.

ID	Term
D016638	Critical Illness
D012769	Shock
D011655	Pulmonary Embolism
D014947	Wounds and Injuries
D029424	Pulmonary Disease, Chronic Obstructive

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008171	Lung Diseases