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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06404151
Enrollment
70
Registered
2024-05-08
Start date
2023-07-01
Completion date
2024-08-01
Last updated
2024-05-14

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

Conditions

Oxygen Deficiency

Keywords

Oxygen reserve index,, Preoxygenation, Cerebral Oxygen Saturation

Brief 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.

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

Interventions

DEVICEmonitoring

rc02, ORI , spO2

Sponsors

Dr. Lutfi Kirdar Kartal Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patientsafter intubation time until spO2 reaches to 97% and 94% and ori reaches to the plato.Expected to take approximately five minutesThe 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)

Secondary

MeasureTime frameDescription
Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patientstime until spo2 is 94% and 97% and ori reaches to the plato.Expected to take approximately five minutesOur secondary aim is; To determine whether there is a correlation between the changing trend of ORI and rcSO2 in obese patients.

Countries

Turkey (Türkiye)

Contacts

Primary ContactGülten A Arslan, Assos Prof
gulten.arslan@yahoo.com.tr05325620366
Backup ContactBanu Eler Cevik, Prof
banueler@yahoo.com5323969536

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026