Oxygen Reserve Index Predicting Hypoxemia

NCT05480748 | Completed DMC

• 1 other identifier: DrLutfiKirdarANEST
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

After obtaining the approval of the hospital ethics committee, this prospective, observational study included written informed consent from 51 participants with 19\<BMI\<25 m/kg2 and 51 participants with BMI\>40 m/kg2 undergoing an elective surgical requiring endotracheal intubation. In addition to standard monitors, an oxygen reserve index (ORI) sensor was placed and baseline values were recorded. The participants were preoxygenated until end expiratory oxygen concentration (EtO2) is reached 90%. After anesthesia induction and endotracheal intubation, the breathing circuit was not connected endotracheal tube until the peripheral oxygen saturation (SpO2) decreased until 95%.ORİ and SpO2 values were continuously recorded. Time of tolerable apnea, ORI warning, SpO2 warning and added warning were also recorded.

Conditions

Oxygen Deficiency; Apnea

Keywords

Oxygen reserve index,; Tolerable apnea time,; Oxygen reserve index warning time,; Preoxygenation,; Percutaneous oxygen saturation warning time

Outcome Measures

Primary Outcomes (1)

• In morbidly obese patients oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two to set deadlines in specific time periods.

  Primary endpoint; To evaluate whether ORi provides an earlier, more relevant clinical warning of impending desaturation compared to pulse oximetry in morbidly obese patients.

  'Time until ORI reaches to 0.24 (It is evaluated in the first 15 minutes after the patient is given anesthesia)

Secondary Outcomes (2)

• In morbidly obese patients oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two to set deadlines in specific time periods.

  Time until SpO2 drops to 95% after ORi reaches 0.24 (until 30 minutes)

• In morbidly obese patients oxygen reserve index (ORi) warning time, SpO2 warning time, and added warning time defined as the difference between the two to set deadlines in specific time periods.

  Time from intubation until SpO2 drops to 95% (until 30 minutes)

Study Arms (2)

Group 1: 19>BMI<25 AND BMI>40

51 patients with BMI\>40 kg/m2 (morbidly obesity) and 51 patients with 19\<BMI\<25 kg/m2 (normal BMI), 18-75 aged, American Society of Anesthesiologists (ASA) physical status I-III scheduled for an elective surgical procedure requiring general anesthesia with endotracheal intubation.

Device: monitoring

Normal body mass index and morbidly obese groups

51 patients with BMI\>40 kg/m2 (morbidly obesity) and 51 patients with 19\<BMI\<25 kg/m2 (normal BMI), 18-75 aged, American Society of Anesthesiologists (ASA) physical status I-III scheduled for an elective surgical procedure requiring general anesthesia with endotracheal intubation.

Device: monitoring

Interventions

monitoring DEVICE

ORI warning time, SpO2 warning time, added time were recorded.

Group 1: 19>BMI<25 AND BMI>40; Normal body mass index and morbidly obese groups

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

102 patients, ASA 1-3, 18-75 years

You may qualify if:

• years,
• ASA 1-3,
• BMI\>40 kg/m2 (morbidly obesity)
• \<BMI\<25 kg/m2 ,
• Elective surgical procedure requiring general anesthesia with endotracheal intubation

You may not qualify if:

• History of cardiopulmonary disease,
• \<BMI\<40 kg m2,
• \<18 years of age,
• Difficult intubation,
• Pregnancy,
• Hemoglobinopathies
• Preoperative hemoglobin of less than 10.0 mg/dL

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)

Location

Related Publications (3)

• 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

• Tsymbal E, Ayala S, Singh A, Applegate RL 2nd, Fleming NW. Study of early warning for desaturation provided by Oxygen Reserve Index in obese patients. J Clin Monit Comput. 2021 Aug;35(4):749-756. doi: 10.1007/s10877-020-00531-w. Epub 2020 May 18.

  PMID: 32424516 RESULT

• Saracoglu KT, Arslan G, Saracoglu A, Sezen O, Ratajczyk P, Gaszynski T. Oxygen reserve index vs. peripheral oxygen saturation for the prediction of hypoxemia in morbidly obese patients: a prospective observational study. BMC Anesthesiol. 2024 Oct 11;24(1):367. doi: 10.1186/s12871-024-02755-8.

  PMID: 39394112 DERIVED

MeSH Terms

Conditions

Hypoxia; Apnea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Gülten Arslan, Dr

  University of Health science Kartal Dr Lütfi Kırdar Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 29, 2022
• Study Start: April 1, 2022
• Primary Completion: May 30, 2022
• Study Completion: June 23, 2022
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)