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Clinical Trials/CTRI/2025/01/079241
CTRI/2025/01/079241
Not yet recruiting
Phase 3

Comparison of Laryngeal Mask Airway Protector and Intubating Laryngeal Mask Airway for Ease of Fiberoptic-Guided Tracheal Intubation in Adult Patients: A One-Year Hospital-Based Randomized Control Trial

Dr Kevin Santosh Joseph1 site in 1 country68 target enrollmentStarted: February 1, 2025Last updated:

Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Dr Kevin Santosh Joseph
Enrollment
68
Locations
1
Primary Endpoint
To compare the ease for fibreoptic-guided tracheal intubation through the Intubating LMA with the LMA Protector.

Overview

Brief Summary

Airway management is crucial during general anesthesia and emergencies, with difficult intubation rates ranging from 0.05% to 18%. Supraglottic airway devices (SADs) are effective alternatives, offering high success rates for blind insertions and ease of use without extensive training. Fiberoptic-guided tracheal intubation improves success compared to blind techniques, requiring clear visibility of the glottic aperture through the SAD. However, limited studies compare SADs for fiberoptic intubation, highlighting the need for further research.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA status I, II, III Patients undergoing elective surgery under general anaesthesia Patients willing to give consent.

Exclusion Criteria

  • Patients undergoing emergency surgeries Patients not willing to give consent Patients with pharyngeal pathology Patients having anatomical deformity of mouth, pharynx and larynx Patients with high risk for aspiration Patients with high airway resistance (severe obesity) Pregnant patients.

Outcomes

Primary Outcomes

To compare the ease for fibreoptic-guided tracheal intubation through the Intubating LMA with the LMA Protector.

Time Frame: 0 minutes, (Intraoperative)

Secondary Outcomes

  • To evaluate the position of the LMA Protector and Intubating LMA with respect to the glottic aperture.(0 minutes, (Intraoperative))

Investigators

Sponsor
Dr Kevin Santosh Joseph
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Kevin Santosh Joseph

KLE DR Prabhakar Kores hospital

Study Sites (1)

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