Comparison of High Flow Nasal Oxygenation and Face Mask Oxygenation for Prolongation of Safe Apnoea Time in Obese Patients Undergoing Elective Surgery under General Anaesthesia
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- ABVIMS and Dr Ram Manohar Lohia Hospital
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- 1. Number of patients in each group in whom apnoea time is less than 6 minutes.
Overview
Brief Summary
This is an interventional parallel group study design to compare high flow nasal oxygenation and face mask oxygenation for prolongation of safe apnoea time in obese patients undergoing elective surgery under general anaesthesia ,since there is a paucity of studies in the Indian population for the same.The primary objective is to compare high flow nasal oxygenation and face mask oxygenation for prolongation of safe apnoea time in obese patients undergoing elective surgery. The secondary objective are to compare ventilation and assess change in hemodynamic parameters and compare patient comfort between the two techniques. Patients will be allocated in two groups ,with 31 patients in each group . Group A patients will receive preoxygenation with High Flow Nasal Oxygenation at 40L/minute for 1 minute and 70L/minute for 2 minutes ; Group B patients will recieve preoxygenation with 100% oxygen through tightly held face mask at 10L/minute with CPAP of 5 cm of H2O. The primary outcome measures are number of patients in each group in whom apnoea time is less than 6 minutes and time taken for spo2 to reach 94% .The secondary outcome measures are maximum etco2 reached after start of ventilation, arterial blood gas analysis at baseline,at the end of preoxygenation and at the end of apnoea time, hemodynamic changes and patients comfort level.The data will be collected ,analysed and statistically evaluated .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Body mass index (BMI) ≥30 kg/m2.
Exclusion Criteria
- •Patients with risk factors for difficult airway (indication for flexible optic intubation, high risk of regurgitation or expected difficult mask ventilation).
- •Uncontrolled gastric reflux disease.
- •Inability to breathe through nose due to nasopharyngeal obstruction or compulsive mouth breather.
- •Pregnant patients.
- •Known case of any systemic disorder such as cardiac, respiratory, renal or hepatic.
Outcomes
Primary Outcomes
1. Number of patients in each group in whom apnoea time is less than 6 minutes.
Time Frame: Every 1 minute for 6 minutes
2. In these patients, time taken for SPO2 to reach 94% after induction of anaesthesia.
Time Frame: Every 1 minute for 6 minutes
Secondary Outcomes
- 1) Maximum EtCO2 reached after start of ventilation.(2) Arterial blood gas analysis will be done at the following intervals. Baseline on room air , at the end of preoxygenation which is also start of apnoea time, and at the end of apnoea time.)
Investigators
Falak Faizan
ABVIMS and RML Hospital