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

NCT07715708 — Not applicable, Not yet recruiting, 70 participants, Benha University

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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

Registry	NCT07715708, acronym LMA insertion
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, supportive care
Enrollment	70 (Estimated)
Sponsor	Benha University (Other)
Conditions	LMA, Ventilation
Interventions	LMA insertion by Standard technique, LMA insertion by Two-Person Lateral Rotation Technique (Device)
Dates	start 2026-07-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-01-01 (estimated), first posted 2026-07-20, last updated 2026-07-20
Locations	1 site in Egypt

-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

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+Arms and interventions

Arm	Type	Interventions	Description
standard group	Placebo comparator	Device: LMA insertion by Standard technique	stanedred LMA insertion
2 persons group	Active comparator	Device: LMA insertion by Two-Person Lateral Rotation Technique	2 person lateral rotation LMA insertion

LMA insertion by Standard technique (Device): Standard Brain Technique for Laryngeal Mask Airway Placement
LMA insertion by Two-Person Lateral Rotation Technique (Device): Novel Two-Person Lateral Rotation Technique of LMA insertion

+Outcome measures

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 [1 minute after LMA insertion]

Secondary outcomes

Insertion time [20-90 seconds from picking up the LMA to be inserted in the mouth]: Interval from picking up the LMA to confirmation of effective ventilation (square-wave capnogram, no audible leak at 20 cmH₂O, normal chest movement)
Number of attempts [2-3 minutes after induction of anesthesia]: Recorded up to a maximum of three; failure defined as inability to achieve effective ventilation after three attempts
Need for manipulations [1-2 minutes after induction of anesthesia]: Chin lift, jaw thrust, head extension, neck flexion, or moderate advancement recorded as binary
Oropharyngeal leak pressure (OLP) [1-2 minutes after insertion of LMA]: 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
Complications: [immediate after removal of LMA ,1,2,4,24 hours. post operative]: 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)

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Benha University Hospital	Banhā	Egypt