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

NCT06404151 | Recruiting

• 1 other identifier: 2023/514/246/17
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxygen Deficiency

Keywords

Oxygen reserve index,; Preoxygenation; Cerebral Oxygen Saturation

Outcome Measures

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)

  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

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

Study Arms (1)

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

monitoring DEVICE

rc02, ORI , spO2

Obese Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 28791567 RESULT

• 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.

  PMID: 32815872 RESULT

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gülten A Arslan, Assos Prof

  Dr Lütfi Kırdar City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gülten A Arslan, Assos Prof

CONTACT

05325620366; gulten.arslan@yahoo.com.tr

Banu Eler Cevik, Prof

CONTACT

5323969536; banueler@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assos prof

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: May 8, 2024
• Study Start: July 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)