NCT07715708

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Jul 2026Jan 2027

Study Start

First participant enrolled

July 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 2, 2026

Last Update Submit

July 16, 2026

Conditions

Outcome Measures

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

    1 minute after LMA insertion

Secondary Outcomes (5)

  • 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

Study Arms (2)

standard group

PLACEBO COMPARATOR

stanedred LMA insertion

Device: LMA insertion by Standard technique

2 persons group

ACTIVE COMPARATOR

2 person lateral rotation LMA insertion

Device: LMA insertion by Two-Person Lateral Rotation Technique

Interventions

Standard Brain Technique for Laryngeal Mask Airway Placement

standard group

Novel Two-Person Lateral Rotation Technique of LMA insertion

2 persons group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University Hospital

Banhā, Egypt

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 20, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations