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Clinical trial to study efficacy of Pre Oxygenation with cushioned tight fitting face mask in 20 degrees head up position versus High flow nasal oxygen in supine position in elective surgeries -A Prospective,Randomised,Controlled Study.

Pre Oxygenation with cushioned tight fitting face mask in 20 degrees head up position versus High flow nasal oxygen in supine position in elective surgeries -A Prospective,Randomised,Controlled Study. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074324
Enrollment
60
Registered
2024-09-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Pre oxygenation with Cushioned Tight Fitting Face Mask in 20 degrees Head up Position: Pre oxygenation is done with Cushioned Tight Fitting Face Mask in 20 degrees Head up Position for

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.American society of anaesthesiologists physical status(ASA) I,II 2.Patients of age 18to 65 years. 3. Body mass index (BMI) less than 30kg/m2. 4.Patients undergoing Elective surgeries under general anaesthesia.

Exclusion criteria

Exclusion criteria: 1.Patient refusal to give consent. 2.Pregnant women. 3.Patient having Nasal obstruction. 4.Baseline oxygen saturation less than 96% while breathing on room air in sitting position . 5.Anticipated Difficult Airway Mallampati grade [MPG]greater or equal to 3 6.Previous allergy to drugs used in standard anaesthetic regimen.

Design outcomes

Primary

MeasureTime frame
To record the time to desaturate to 92% from the onset of apnoea.Timepoint: Time taken by patient from point of visual confirmation of apnoea (T0) to point of desaturation to 92% (T1)—

Secondary

MeasureTime frame
1.To record lowest Saturation of peripheral oxygen (SPO2) during first five breaths immediately post procedure. 2.To record Highest End Tidal Carbondioxide (ETCO2) during first five breaths immediately post procedure. 3.Number of intubation attempts. 4.Usage of special laryngoscopes other than Macintosh Blade number 3. 5. Cormack lehane grading. 6. Signs of regurgitation in pharynx while intubation. 7.Tolerance of patient to the device subjective discomfort Likert scale Timepoint: Lowest SPO2,Highest ETCO2 recorded in 1,2,3,4,5 breaths after connecting to oxygen—

Countries

India

Contacts

Public ContactDr N Hemanth

Sri Venkateswara Institute of Medical Sciences

hemanthn1973@gmail.com9440285634

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026