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Clinical Trials/NCT07715708
NCT07715708Not yet recruitingNot Applicable

First-Attempt Insertion Success of a Novel Two-Person Lateral Rotation Technique Versus the Standard Brain Technique for Laryngeal Mask Airway Placement: A Randomized Controlled Trial

Benha University1 site in 1 country70 target enrollmentStarted: July 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
70
Locations
1
Primary Endpoint
First-attempt insertion success rate, defined as successful placement achieving effective ventilation on the first introduction of the LMA into the oral cavity

Study Overview

Brief Summary

The goal of this clinical trial is to learn if two person lateral rotation technique of LMA insertion is more successful than the standard technique in achieving effective ventilation on the first introduction of the LMA .The main questions it aims to answer are:

Does two person lateral rotation technique of LMA insertion lower the number of times needed to inesrt the LMA ?

Researchers will compare two person lateral rotation technique of LMA insertion to standard technique to see if it is more successful

Participants will be subjected to the two way of LMA insertion

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult patients aged 18-65 years
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Scheduled for elective superficial surgical procedures under general anesthesia (e.g., limb orthopedic surgery, hernioplasty, soft tissue excision)
  • Anticipated surgical duration < 90 minutes
  • Body mass index (BMI) 18.5-30 kg/m²

Exclusion Criteria

  • - Anticipated difficult airway (Mallampati grade IV, thyromental distance < 6 cm, limited neck extension)
  • History of gastroesophageal reflux disease or increased aspiration risk
  • Full stomach or emergency surgery - Intra-abdominal, laparoscopic, head and neck, or prone-position procedures - Known allergy to anesthetic agents
  • Pregnancy
  • Previous pharyngeal or laryngeal surgery - Inability to provide informed consent

Outcomes

Primary Outcomes

First-attempt insertion success rate, defined as successful placement achieving effective ventilation on the first introduction of the LMA into the oral cavity

Time Frame: 1 minute after LMA insertion

Secondary Outcomes

  • Insertion time(20-90 seconds from picking up the LMA to be inserted in the mouth)
  • Number of attempts(2-3 minutes after induction of anesthesia)
  • Need for manipulations(1-2 minutes after induction of anesthesia)
  • Oropharyngeal leak pressure (OLP)(1-2 minutes after insertion of LMA)
  • Complications:(immediate after removal of LMA ,1,2,4,24 hours. post operative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Taghreed Elshahat Sakr

lecturer

Benha University

Study Sites (1)

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