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Status unknownNCT06404151Updated May 14, 2024

Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patients

An observational study in Oxygen Deficiency, sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital · Observational

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
70
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The primary aim of this study is to compare the effectiveness of ORI and rcSO2 in predicting hypoxia early in obese patients who are sensitive to hypoxia. Our secondary aim is; To determine whether there is a correlation between the changing trend of ORI and rcSO2 in obese patients.

Read the detailed description

Standard noninvasive monitoring will be applied to the patients taken to the operating table, and heart rate, mean arterial pressure, peripheral oxygen saturation (SpO2), oxygen reserve index (ORI), regional cerebral oxygen saturation, etCO2 values will be recorded. Cerebral oximeter probe placed in the middle of the forehead (every second Cerebral oxygen saturation will be continuously monitored using a rcSO2 reading) (Massimo)Preoxygenation will be performed until the expiratory O2 concentration is 90% (during spontaneous ventilation, FIO2 will be kept between 100% 6 lt7min flow rate and EtCO2 30-35 mmHg). 2 mg midazolam, 2 ug General anesthesia with /kg fentanyl, 3 mg/kg propofol, 0.6 mg/kg rocuronium and 100% O2 will be applied and intubated with a videolaryngoscope. The breathing circuit will be disconnected from the endotracheal tube until the SpO2 drops to 94%. At that time, the breathing circuit will be connected and the patients will be ventilated with 100% FiO2, 8 ml kg-1 ideal body weight, targeted tidal volume, and 5 cm H2O positive end-expiratory pressure until the ORI plateaus. Throughout this process, ORI and cerebral oxygen saturation will be recorded continuously. ORI and rcO2 data will be compared at seven specific time points ( (1) during the basal period; (2) at the end of preoxygenation when ORI reaches a plateau; (3) at the beginning of intubation; (4) when SpO2 reaches 97%; (5) when SpO2 reaches 94% (6) ORI reaches a plateau again (during ventilation with 100% FiO2), and (7) SpO2 reaches baseline

02

Conditions studied

  • Oxygen Deficiency

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Keywords

  • Oxygen reserve index,
  • Preoxygenation
  • Cerebral Oxygen Saturation
03

In context

Hypoxia

1,245 studies on the registry are indexed under Hypoxia; 239 are open to participants now.

This study's planned enrollment of 70 is close to the median of 68 across 338 observational studies indexed under Hypoxia.

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Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital is the lead sponsor of 78 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

60 patients with ASA I-III, of both genders, between 18-75 years of age, with a BMI of 40>30 kg m2 and intubated under general anesthesia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ASA I-III patients
  • The ages of 18-75
  • Obese BMI (40>BMI>30 kgm\^2)
  • Undergoing intubated elective surgery

Exclusion criteria

Exclusion Criteria:

  • Patients with significant cardiopulmonary comorbidities
  • BMI>40 kgm\^2 and BMI\<30 kg m\^2
  • ASA>3
  • Patients under 18 years and over 75 years of age
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • Obese Patients

    60 patients with ASA I-III, of both genders, between 18-75 years of age, with a BMI of 40\>30 kg m2 and intubated under general anesthesia

    Device: monitoring

Interventions

  • Devicemonitoring

    rc02, ORI , spO2

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What researchers measure

Primary outcomes

  1. Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patients

    The primary aim of this study is to compare the effectiveness of ORI and rcSO2 in predicting hypoxia early in obese patients (BMI 30-40 kg/m\^2) (weight and height will be combined to report BMI in kg/m\^2)

    Time frame: after intubation time until spO2 reaches to 97% and 94% and ori reaches to the plato.Expected to take approximately five minutes

Secondary outcomes

  1. Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patients

    Our secondary aim is; To determine whether there is a correlation between the changing trend of ORI and rcSO2 in obese patients.

    Time frame: time until spo2 is 94% and 97% and ori reaches to the plato.Expected to take approximately five minutes

07

Study locations

1 of 1 sites recruiting
  • University of Health Science, Kartal Dr Lütfi Kırdar Training and Research Hospital
    Istanbul, Turkey (Türkiye)
    Recruiting
08

References and documents

Publications

  • Scheeren TWL, Belda FJ, Perel A. The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):379-389. doi: 10.1007/s10877-017-0049-4. Epub 2017 Aug 8. PubMed 28791567 ↗
  • Fleming NW, Singh A, Lee L, Applegate RL 2nd. Oxygen Reserve Index: Utility as an Early Warning for Desaturation in High-Risk Surgical Patients. Anesth Analg. 2021 Mar 1;132(3):770-776. doi: 10.1213/ANE.0000000000005109. PubMed 32815872 ↗

Individual participant data

Plan to share: No — I will share the parameters and results of the study

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06404151
Lead sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Responsible party
Gülten Arslan (assos prof, Dr. Lutfi Kirdar Kartal Training and Research Hospital) — Principal investigator
First posted
May 8, 2024
Start date
Jul 1, 2023
Primary completion
Aug 1, 2024 (estimated)
Completion
Aug 1, 2024 (estimated)
Last update
May 14, 2024

Study contacts

Gülten A Arslan, Assos Prof
Contact
gulten.arslan@yahoo.com.tr
05325620366
Banu Eler Cevik, Prof
Contact
banueler@yahoo.com
5323969536
Gülten A Arslan, Assos Prof
principal investigator · Dr Lütfi Kırdar City Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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