NCT05341258

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

August 24, 2022

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

April 17, 2022

Last Update Submit

August 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Evaluation of correlation between PaCO2 and ETCO2 gradient difference and mortality in intubated critical care patients and mortality rates

    6 months

Secondary Outcomes (2)

  • ICU Length of Stay

    6 months

  • Ventilator Free Days

    6 months

Study Arms (1)

Critical Care Patients whom intubated last 24 hours

OTHER

Critical Care Patients whom intubated last 24 hours

Diagnostic Test: EtCO2Diagnostic Test: PaCO2

Interventions

EtCO2DIAGNOSTIC_TEST

EtCO2

Critical Care Patients whom intubated last 24 hours
PaCO2DIAGNOSTIC_TEST

PaCO2

Critical Care Patients whom intubated last 24 hours

Eligibility Criteria

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

You may qualify if:

  • Critical Care Patients intubated in last 24 hours.

You may not qualify if:

  • Patients younger than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Training Research Hospital

Istanbul, 34255, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Critical IllnessShockPulmonary EmbolismWounds and InjuriesPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung Diseases, ObstructiveChronic Disease

Study Officials

  • Ulku Aygen Turkmen, Proffessor

    Director of Anesthesiology and Reanimation Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2022

First Posted

April 22, 2022

Study Start

January 1, 2022

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

August 24, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations