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Safety comparison of standard versus lower fraction of inspired oxygen during induction of anesthesia: a pragmatic randomized control non-inferiority study

Safety comparison of standard versus lower fraction of inspired oxygen during induction of anesthesia: a pragmatic randomized control non-inferiority study

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241215012
Enrollment
56
Registered
2024-12-15
Start date
2024-12-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative preoxygenation Oxygen Reserve Index apnea time hyperoxia hypoxemia

Interventions

Giving 60% oxygen during preoxygenation and bag mask ventilation ,Giving 100% oxygen during preoxygenation and bag mask ventilation
Experimental Drug,Active Comparator Drug
Low FiO2,Standard FiO2

Sponsors

Ratchadapisek Research Funds
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adult patient age 18-80 years old scheduled for elective non-cardiac surgery under general anesthesia with endotracheal tube- 2. ASA physical status I - III 3. BMI between 18-30 kg/sq.m

Exclusion criteria

Exclusion criteria: 1. Not giving consent 2. History of difficult intubation or anticipated difficult intubation 3. Indicated for rapid sequence induction or awake intubation 4. Hemoglobin concentration less than 10 g/dL 5. Presence of factors confounding co-oximetry such as hemoglobinopathies 6. CNS disorders 7. Pregnancy 8. Patients with limited cardiopulmonary reserve including severe cardio/pulmonary diseases, obstructive sleep apnea, or resting oxygen saturation less than 95% 9. Oxygen saturation after preoxygenation less than 100%

Design outcomes

Primary

MeasureTime frame
Safe apneic time When SpO2 reaches 94% Stop watch

Secondary

MeasureTime frame
Added warning time When SpO2 reaches 94% Stop watch,Incidence of hyperoxia Induction phase of anesthesia Couting incidence or ORi more than 0.55

Countries

Thailand

Contacts

Public ContactPongpol Sirilaksanamanon

King Chulalongkorn Memorial Hospital

pongpol.siri@gmail.com026494000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026