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ORI and ETCO₂ Relationship With Arterial Blood Gas During Apnea Test

Evaluation of the Relationship of Oxygen Reserve Index (ORI) and End-Tidal Carbon Dioxide (ETCO₂) With Arterial Blood Gas Parameters During the Apnea Test

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06983990
Enrollment
35
Registered
2025-05-22
Start date
2023-07-01
Completion date
2025-06-01
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Death

Keywords

Oxygen Reserve Index, ORI, Apnea test, Brain Death, End-Tidal Carbon Dioxide, ETCO2, Hyperoxia, Hypoxia

Brief summary

This observational study aims to evaluate the relationship between the Oxygen Reserve Index (ORI) and End-Tidal Carbon Dioxide (ETCO2) values with arterial blood gas parameters in patients undergoing the apnea test for the diagnosis of brain death. The study will examine the correlation between ORI and PaO2, as well as between ETCO2 and PaCO2. The primary objective is to assess the effectiveness of ORI in evaluating oxygenation and its applicability in the apnea test. The study will also evaluate the routine use of ORI in monitoring PaO2 and its potential benefits compared to traditional methods.

Detailed description

This observational study aims to evaluate the relationship between the Oxygen Reserve Index (ORI) and partial arterial oxygen pressure (PaO2), as well as between End-Tidal Carbon Dioxide (ETCO2) and partial arterial carbon dioxide pressure (PaCO2) in patients undergoing an apnea test for the diagnosis of brain death. ORI is a relatively new, non-invasive monitoring tool that allows continuous and real-time assessment of oxygenation status. It is a dimensionless parameter with values ranging from 0 to 1. ORI is based on a multi-wavelength pulse co-oximeter that detects light absorption in both arterial and venous blood through a probe. It is designed to estimate PaO2 values in the 100-200 mmHg range, as SpO2 typically reaches ≥97% when PaO2 exceeds 80 mmHg, making it unable to reflect higher PaO2 levels accurately. The apnea test is a critical procedure for the diagnosis of brain death, in which the presence or absence of spontaneous breathing in response to carbon dioxide accumulation is evaluated. During the test, arterial blood gas (ABG) measurements are taken to monitor the rise in PaCO2. Before the test begins, the patient is ventilated with 100% oxygen to raise PaO2 above 200 mmHg, which is confirmed with a pre-test ABG sample. The patient must also be normocapnic prior to testing. As arterial blood sampling is an invasive procedure, this study aims to assess the predictability of PaO2 and PaCO2 using ORI and ETCO2 in the pre-test phase. The primary objective is to determine the capability of ORI to monitor oxygenation status and evaluate its potential to detect hypoxia earlier. Moreover, by comparing ORI to conventional methods, this study seeks to explore its potential routine use in clinical settings for PaO2 monitoring and its possible advantages. In patients undergoing apnea testing for suspected brain death, this study may help determine whether ORI offers benefits over current monitoring approaches and whether it can reduce dependence on invasive ABG sampling. Furthermore, hyperoxia, like hypoxia, poses various clinical risks. The clinical use of ORI alongside SpO2 may help prevent hyperoxia and enable earlier detection of hypoxia. This may enhance patient safety and improve clinical decision-making in critical care environments.

Interventions

OTHERNo intervention (observational monitoring only)

No intervention is applied. This is an observational study evaluating the correlation between non-invasive monitoring parameters and arterial blood gas values during apnea testing.

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who meet all the prerequisites for initiating the brain death diagnosis process and for whom the decision to perform the apnea test for diagnosis of brain death. * Patients aged 18 years or older. * Patients who have provided verbal and written consent from their first-degree relatives.

Exclusion criteria

* Patients whose first-degree relatives do not consent to participation in the study. * Patients in whom the ORI probe cannot be used due to circulatory disturbances in the extremities

Design outcomes

Primary

MeasureTime frameDescription
Correlation between Oxygen Reserve Index (ORI) and arterial PaO2 during apnea testBefore and at specific intervals during the apnea testAssess the correlation between non-invasive ORI values obtained from Masimo pulse CO-oximeter and arterial partial pressure of oxygen (PaO2) measured from arterial blood gases during the apnea test.

Secondary

MeasureTime frameDescription
Correlation between End-Tidal Carbon Dioxide (ETCO2) and arterial PaCO2 during apnea testBefore the apnea test, at the start of the test, and end of the testAssess the correlation between ETCO2 values from capnography and arterial partial pressure of carbon dioxide (PaCO2)

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORNilay SERTDEMIR, MD

Health Sciences University Bursa Yüksek İhtisas Training and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026