To evaluate the efficacy of two human airway devices - Baska mask and LMA Protector used for anesthetizing patients.
Phase 4
- Conditions
- Health Condition 1: D099- Carcinoma in situ, unspecified
- Registration Number
- CTRI/2024/05/066672
- Lead Sponsor
- Kalyan Singh Superspeciality cancer institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
18- 65 years
all patients Scheduled for elective surgery under general anaesthesia in supine position with expected duration of surgery less than 2 hours.
Exclusion Criteria
1.Upper airway anatomic variation or pathology.
2.Predicted difficult airway
3.High risk of aspiration (full stomach, gastroesophageal reflux, Pregnancy)
4.Body mass index greater than 30 kg/m2,
5.Patient refusal to participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oropharyngeal leak pressure during positive pressure ventilation. <br/ ><br> <br/ ><br>This outcome measure was used for sample size calculation.Timepoint: it will be assessed only once immediately after insertion and once successful ventilation is confirmed.
- Secondary Outcome Measures
Name Time Method 1.First attempt success rate. <br/ ><br>2.Accuracy of size as per manufacturer recommendation. <br/ ><br>3.Insertion time. <br/ ><br>4.Ease of gastric tube placement. <br/ ><br>5.Anatomic position of device. <br/ ><br>6.Presence of blood & gastric contents on the device. <br/ ><br>7.Incidence & severity of postoperative sore throat at 1h, 4h & 24 h after surgery. <br/ ><br>8.Ease of insertion of SGAD. <br/ ><br>Timepoint: 1. Secondary outcome measures numbered 1-5,8 will be assessed immediately after insertion, only once. <br/ ><br>2.Secondary outcome measure number 6, will be assessed at the end of surgery. <br/ ><br>3. Secondary outcome measures number 7 will be assessed at 1h, 4h & 24 h after surgery. <br/ ><br>