Comparison Between a Two Person Insertion With Lateral Rotation Technique of LMA and the Classic Technique

NCT05084612 | Suspended

• 1 other identifier: RC4-4-2021
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The laryngeal Mask Airway was developed by Brain in 1981 and was available for clinical use in the United States by 1992 and has become very popular in routine medicine practice during 10 past years . LMA would serve as a choice to be used in the emergency situations even by the inexperienced users . Nowadays due to the increasing number of outpatient anesthesia and use of short-acting anesthetics almost without the use of any muscle relaxants requires an appropriate way for safe LMA insertion. As LMA insertion is generally performed blindly, clinicians are always in search of how to place and maintain the LMA in appropriate position.

Conditions

Airway Complication of Anesthesia

Outcome Measures

Primary Outcomes (1)

• the success rate of first attempt insertion of the LMA

  confirmed insertion of LMA without need for further attempts.

  from induction of anesthesia till patient connected to the ventilator.

Secondary Outcomes (5)

• LMA insertion time

  up to 30 minutes post-induction of anesthesia

• The number of insertion attempts

  up to 30 minutes post-induction of anesthesia

• number of manipulations needed during insertion

  up to 30 minutes post-induction of anesthesia

• The incidence of complications following insertion of LMA

  up to 1 day postoperative

• Heart rate (HR)

  first 15 minutes post-induction of anesthesia

Study Arms (2)

control group (S)

PLACEBO COMPARATOR

LMA will be placed using the standard Brain's insertion technique.

Device: standard LMA insertion

Rotational group (R)

ACTIVE COMPARATOR

LMA will be placed using a two Person Insertion with lateral rotation technique.

Device: New technique LMA insertion

Interventions

standard LMA insertion DEVICE

Following pre-oxygenation, anaesthesia will be induced with atropine 0.1mg/kg, Fentanyl 2 µg /kg, Propofol 2 mg/kg and atracurium 0.5 mg/kg. When neuromuscular blockade will be complete the laryngeal mask will be inserted with using the standard method described by Brain; after lubrication of the posterior aspect of the partially deflated mask, the patient's head will be positioned with head extended at the atlanto-axial joint and flexed at the neck with non-dominant hand. The LMA will be held like a pen and index finger will be placed at the junction of LMA tube and cuff. Index finger will be used to press the LMA against hard palate and posterior pharyngeal wall until definite resistance felt at the base of the hypopharynx. LMA will then be held with non-dominant hand and index finger will be removed.

control group (S)

New technique LMA insertion DEVICE

Following pre-oxygenation, anaesthesia will be induced with atropine 0.1mg/kg, Fentanyl 2 µg /kg, Propofol 2 mg/kg and atracurium 0.5 mg/kg. When neuromuscular blockade will be complete LMA will be inserted by a two Person Insertion with lateral rotation Technique; after lubrication of the posterior aspect of the partially deflated mask, the assistant will achieve jaw thrust and mouth opening then LMA will be inserted by the anaesthiologist. LMA will be inserted by holding the mask by index, middle finger and thumb; after insertion of the entire cuff inside the mouth, the LMA will be rotated anticlockwise through 90° (the inner surface of LMA will be directed medially towards the mouth cavity) and advanced through the side of the tongue until resistance felt, then turned back in the hypopharynx.

Rotational group (R)

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status grade I-II,
• Age between 20-55 years old
• undergoing minor surgeries under general anaesthesia using LMA

You may not qualify if:

• patients at Risk of aspiration,
• Mouth opening ˂ 2.5 cm,
• BMI ≥ 35 kg/m2,
• dental problems,
• recent history of upper airway infection,
• gastro-oesophageal reflux disease and
• limited extension of the neck.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Samar Rafik Amin

Banhā, Qalyubia Governorate, 13511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical ICU

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 20, 2021
• Study Start: August 2, 2021
• Primary Completion: November 20, 2025
• Study Completion: December 25, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

EG (1)