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NCT Number: NCT07715708

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

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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Key information

Conditions

LMA Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Ventilation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  1. Insertion time

    Time frame: 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)

  2. Number of attempts

    Time frame: 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

  3. Need for manipulations

    Time frame: 1-2 minutes after induction of anesthesia

    Chin lift, jaw thrust, head extension, neck flexion, or moderate advancement recorded as binary

  4. Oropharyngeal leak pressure (OLP)

    Time frame: 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

  5. Complications:

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Acronym: LMA insertion

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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