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Not yet recruitingNCT07715708LMA insertionUpdated Jul 20, 2026

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

An interventional study of LMA insertion by Standard technique and LMA insertion by Two-Person Lateral Rotation Technique in LMA and Ventilation, sponsored by Benha University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Benha University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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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Conditions studied

  • LMA
  • Ventilation
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's planned enrollment of 70 is above the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
70 participants (estimated)

Study arms

  • Placebo comparator
    standard group

    stanedred LMA insertion

    Device: LMA insertion by Standard technique

  • Active comparator
    2 persons group

    2 person lateral rotation LMA insertion

    Device: LMA insertion by Two-Person Lateral Rotation Technique

Interventions

  • DeviceLMA insertion by Standard technique

    Standard Brain Technique for Laryngeal Mask Airway Placement

  • DeviceLMA insertion by Two-Person Lateral Rotation Technique

    Novel Two-Person Lateral Rotation Technique of LMA insertion

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What researchers measure

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

    Interval from picking up the LMA to confirmation of effective ventilation (square-wave capnogram, no audible leak at 20 cmH₂O, normal chest movement)

    Time frame: 20-90 seconds from picking up the LMA to be inserted in the mouth

  2. Number of attempts

    Recorded up to a maximum of three; failure defined as inability to achieve effective ventilation after three attempts

    Time frame: 2-3 minutes after induction of anesthesia

  3. Need for manipulations

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

    Time frame: 1-2 minutes after induction of anesthesia

  4. 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

    Time frame: 1-2 minutes after insertion of LMA

  5. 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)

    Time frame: immediate after removal of LMA ,1,2,4,24 hours. post operative

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07715708
Lead sponsor
Benha University
Responsible party
Taghreed Elshahat Sakr (lecturer, Benha University) — Principal investigator
First posted
Jul 20, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Jul 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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