Comparing oxygen monitoring methods in obese patients during surgery
Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation in Determining Hypoxia in Obese Patients
This study is testing two different ways to monitor oxygen levels in obese patients during surgery to see which one better predicts low oxygen levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Dr. Lutfi Kirdar Kartal Training and Research Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06404151 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the effectiveness of the Oxygen Reserve Index (ORI) and regional cerebral oxygen saturation (rcSO2) in predicting hypoxia in obese patients who are particularly sensitive to low oxygen levels. Patients undergoing elective surgery will be monitored noninvasively for various parameters, including heart rate, blood pressure, and oxygen levels. The study will track changes in ORI and rcSO2 at multiple time points during the preoxygenation and intubation process to assess their correlation and predictive value for hypoxia.
Who should consider this trial
Good fit: Ideal candidates are obese patients aged 18-75 with a BMI between 30 and 40 who are scheduled for elective surgery requiring intubation.
Not a fit: Patients with significant cardiopulmonary comorbidities or those outside the specified age and BMI range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the monitoring of oxygen levels in obese patients, potentially improving their safety during surgery.
How similar studies have performed: While the approach of using ORI and rcSO2 is relatively novel, previous studies have indicated the importance of monitoring oxygen levels in surgical patients, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Istanbul
- University of Health Science, Kartal Dr Lütfi Kırdar Training and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Gülten A Arslan, Assos Prof — Dr Lütfi Kırdar City Hospital
- Study coordinator: Gülten A Arslan, Assos Prof
- Email: gulten.arslan@yahoo.com.tr
- Phone: 05325620366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.