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To evaluate the efficacy of two human airway devices - Baska mask and LMA Protector used for anesthetizing patients.

To evaluate the efficacy of Baska mask and LMA Protector in anesthetized paralysed patients – a prospective randomized comparative study. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066672
Enrollment
70
Registered
2024-05-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: D099- Carcinoma in situ, unspecified

Interventions

Intervention1: Insertion of LMA protector to maintain airway during anesthesia for surgeries lasting less than two hours.: LMA Protector will be inserted for maintaining the airway during anesthesia a

Sponsors

Kalyan Singh Superspeciality cancer institute
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Oropharyngeal leak pressure during positive pressure ventilation. 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

MeasureTime frame
1. First attempt success rate. 2. Accuracy of size as per manufacturer recommendation. 3. Insertion time. 4. Ease of gastric tube placement. 5. Anatomic position of device. 6. Presence of blood & gastric contents on the device. 7. Incidence & severity of postoperative sore throat at 1h, 4h & 24 h after surgery. 8. Ease of insertion of SGAD. Timepoint: 1. Secondary outcome measures numbered 1-5,8 will be assessed immediately after insertion, only once. 2.Secondary outcome measure number 6, will be assessed at the end of surgery. 3. Secondary outcome measures number 7 will be assessed at 1h, 4h & 24 h after surgery.

Countries

India

Contacts

Public ContactDr Ruchi Saxena

Kalyan Singh Superspeciality Cancer Institute

taru_ruchi@yahoo.co.in09140366422

Outcome results

None listed

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