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

Recruiting
Conditions
Oxygen Deficiency
Interventions
Device: monitoring
Registration Number
NCT06404151
Lead Sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
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

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
70
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Obese Patientsmonitoring60 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
Primary Outcome Measures
NameTimeMethod
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 minutes

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)

Secondary Outcome Measures
NameTimeMethod
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 minutes

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

Trial Locations

Locations (1)

University of Health Science, Kartal Dr Lütfi Kırdar Training and Research Hospital

🇹🇷

Istanbul, Turkey

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