First Attempt Insertion Success of Novel Two Person Lateral Rotation Technique V.S Standard Brain Technique for LMA Insertion (LMA insertion)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Ventilation; LMA
• Intervention / Treatment: Device: LMA insertion by Standard technique; Device: LMA insertion by Two-Person Lateral Rotation Technique

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banhā, Egypt
    • Benha University Hospital
    • Contact: Taghreed Sakr, MD degree of anesthesia; Phone Number: 00201112723187; Email: taghreed.sakr@fmed.bu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: standard group; stanedred LMA insertion	Device: LMA insertion by Standard technique; Standard Brain Technique for Laryngeal Mask Airway Placement
Active Comparator: 2 persons group; 2 person lateral rotation LMA insertion	Device: LMA insertion by Two-Person Lateral Rotation Technique; Novel Two-Person Lateral Rotation Technique of LMA insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
First-attempt insertion success rate, defined as successful placement achieving effective ventilation on the first introduction of the LMA into the oral cavity	1 minute after LMA insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion time	Interval from picking up the LMA to confirmation of effective ventilation (square-wave capnogram, no audible leak at 20 cmH₂O, normal chest movement)	20-90 seconds from picking up the LMA to be inserted in the mouth
Number of attempts	Recorded up to a maximum of three; failure defined as inability to achieve effective ventilation after three attempts	2-3 minutes after induction of anesthesia
Need for manipulations	Chin lift, jaw thrust, head extension, neck flexion, or moderate advancement recorded as binary	1-2 minutes after induction of anesthesia
Oropharyngeal leak pressure (OLP)	Measured by closing the expiratory valve at a constant gas flow of 3 L/min with the upper pressure limit set to 30 cmH₂O; the pressure at which an audible leak is detected is recorded	1-2 minutes after insertion of LMA
Complications:	Blood staining on LMA (indicating mucosal trauma), sore throat (assessed postoperatively using a 4-point verbal rating scale), laryngospasm, hypoxia (SpO₂ < 92%), and gastric insufflation (detected by epigastric auscultation)	immediate after removal of LMA ,1,2,4,24 hours. post operative

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Aspiration
• Other Study ID Numbers: RC.14.5.2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No