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

Oxygen Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06404151
• Other study ID #: 2023/514/246/17
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Contact: Gülten A Arslan, Assos Prof
• Phone: 05325620366
• Email: gulten.arslan[@]yahoo.com.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Oxygen Deficiency

Intervention

Device:
• monitoring
rc02, ORI , spO2

Locations

Country	Name	City	State
Turkey	University of Health Science, Kartal Dr Lütfi Kirdar Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Lutfi Kirdar Kartal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. Erratum In: J Clin Monit Comput. 2018 Feb 14;: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	after intubation time until spO2 reaches to 97% and 94% and ori reaches to the plato.Expected to take approximately five minutes
Secondary	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 until spo2 is 94% and 97% and ori reaches to the plato.Expected to take approximately five minutes