Comparision of three different techniques of insertion of specialized airway device called PLMA. In patient undergoing general anesthesia.

Comparision of Flexi-slip stylet, Introducer tool and Standard digital technique of Proseal Laryngeal Mask Airway(PLMA) insertion-A randomized control study. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/07/091862

Enrollment

120

Registered

2025-07-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: Z768- Persons encountering health services in other specified circumstances Health Condition 2: Z768- Persons encountering health services in other specified circumstances

Interventions

Intervention1: Flexi slip Stylet tool technique: The patients will be preoxygenated with 100% oxygen for three minutes before induction of anaesthesia. Pre medication will be administered with Injecti

Eligibility

Inclusion criteria

Inclusion criteria: A) Patients undergoing elective surgeries under general anaesthesia for moderate duration (up to two hours) in supine position. B) Adult patients between 18-60 years of age. C)American society of Anaesthesiologist s (ASA) -classification I-II. D)Patients giving informed written and valid consent.

Exclusion criteria

Exclusion criteria: Patient requiring mechanical ventilation following surgery Inadequate nil by mouth status Pregnant women Limited mouth opening Patient who had upper respiratory tract infection with in past week. Obese patient with body mass index more than 30kg/m2 Patient of upper airway pathology Chronic obstructive pulmonary disease, bronchial asthma, active airway disease. Patient having history of oesophageal or gastric surgeries. Head and neck surgery

Design outcomes

Primary

Measure	Time frame
To estimate the first attempt insertion success rateTimepoint: baseline time T0-at the time of insertion	—

Secondary

Measure	Time frame
A) To determine ease of insertionTimepoint: i. Grade 1:Smooth(no resistance) ii. Grade 2:Mild resistance requiring additional manoeuvres iii. Grade 3:high resistance requiring re-insertion iv. Grade 4:Failed insertion ;A) To estimate time taken for insertion using each of the techniques. Timepoint: nil;To evaluate hemodynamic stability during insertionTimepoint: P1-baseline measurement, P2-immediately after insertion, P3-one minutes after insertion, P4- five minutes after insertion, P5-ten minutes after insertion	—

Measure

Time frame

A) To determine ease of insertionTimepoint: i. Grade 1:Smooth(no resistance) ii. Grade 2:Mild resistance requiring additional manoeuvres iii. Grade 3:high resistance requiring re-insertion iv. Grade 4:Failed insertion ;A) To estimate time taken for insertion using each of the techniques. Timepoint: nil;To evaluate hemodynamic stability during insertionTimepoint: P1-baseline measurement, P2-immediately after insertion, P3-one minutes after insertion, P4- five minutes after insertion, P5-ten minutes after insertion

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Countries

India

Contacts

Public ContactDR SHILPA H M

KMC-RI hubli

milon.mitragotri4@gmail.com7406796763

Outcome results

None listed

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