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NCT Number: NCT06983990

ORI and ETCO₂ Relationship With Arterial Blood Gas During Apnea Test

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Sciences University Bursa Yüksek İhtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention (observational monitoring only)

Other

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.

Primary outcomes

  1. Correlation between Oxygen Reserve Index (ORI) and arterial PaO2 during apnea test

    Time frame: Before and at specific intervals during the apnea test

    Assess 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 outcomes

  1. Correlation between End-Tidal Carbon Dioxide (ETCO2) and arterial PaCO2 during apnea test

    Time frame: Before the apnea test, at the start of the test, and end of the test

    Assess the correlation between ETCO2 values from capnography and arterial partial pressure of carbon dioxide (PaCO2)

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 22, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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