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Clinical Trials/NCT07097662
NCT07097662CompletedNot Applicable

Evaluation of the Effectiveness of Oxygen Reserve Index Monitoring During Pre-oxygenation in Obese Patients

Irem Caner1 site in 1 country60 target enrollmentStarted: February 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Evaluation of the Effectiveness of Oxygen Reserve Index Monitoring During Pre-oxygenation in Obese Patients

Study Overview

Brief Summary

In obese patients, the risk of perioperative complications such as rapid desaturation, atelectasis, difficult mask ventilation, difficult intubation, and hypoxia is higher compared to the normal population. Therefore, preoxygenation is even more critical in the obese patient group. In clinical practice, ETO2 is used as a practical indicator to evaluate sufficient oxygenation during preoxygenation. The Oxygen Reserve Index (ORiⓇ) is a new oxygenation monitoring parameter that is continuously and non-invasively measured by a specialized pulse oximetry device (Masimo, Irvine, CA).The primary objective of the investigators was to observe the correlation between ORIⓇ monitoring and ETO₂ during preoxygenation in obese patients.The secondary objective of the investigators was to evaluate the correlation of ORIⓇ with SpO₂ and PaO₂ in this patient population.

Detailed Description

Obesity is a chronic, progressive, and recurrent disease characterized by abnormal fat accumulation that adversely affects health and increases morbidity and mortality.

According to World Health Organization (WHO) data, the prevalence of obesity among adults aged 18 years and older is reported to be 16%.

Obese patients have an increased risk of perioperative complications compared to the general population, including rapid desaturation, atelectasis, difficult mask ventilation, difficult intubation, and hypoxia.

Therefore, preoxygenation is particularly important in obese patient populations.

The goal of preoxygenation is to maximize the duration during which the patient can tolerate apnea, thereby providing the anesthesiologist with crucial time to secure the airway in cases of planned or unanticipated "cannot ventilate, cannot intubate" scenarios.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with a body mass index (BMI) >35 kg/m² scheduled for elective surgery
  • ASA (American Society of Anesthesiologists) physical status classification I-III
  • Patients aged 18 years and older

Exclusion Criteria

  • Patients with ASA physical status classification IV-V,
  • Psychiatric disorders
  • Severe cardiac arrhythmias
  • Patients with an ejection fraction below 30%
  • Chronic obstructive pulmonary disease (COPD)
  • Those receiving home oxygen therapy
  • Patients requiring supraglottic airway devices, and emergency cases

Outcomes

Primary Outcomes

Evaluation of the Effectiveness of Oxygen Reserve Index Monitoring During Pre-oxygenation in Obese Patients

Time Frame: During 5-minute preoxygenation

Non-invasive ORiⓇ values and ETO₂ levels measured every minute during tidal volume breathing in the preoxygenation period will be analyzed for correlation.

Secondary Outcomes

  • Correlation between ORiⓇ and arterial oxygen pressure (PaO₂) at multiple time points after intubation(30, 60, 90, and 120 minutes after intubation)
  • Correlation between ORiⓇ and peripheral oxygen saturation (SpO₂) at multiple time points after intubation(30, 60, 90, and 120 minutes after intubation)

Investigators

Sponsor
Irem Caner
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Irem Caner

Research Assistant

Kocaeli University

Study Sites (1)

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