LMALMA insertionNCT07715708
First Attempt Insertion Success of Novel Two Person Lateral Rotation Technique V.S Standard Brain Technique for LMA Insertion
A study testing LMA insertion by Standard technique and LMA insertion by Two-Person Lateral Rotation Technique in people with LMA and Ventilation, run by Benha University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- LMA, Ventilation
- What is being tested?
- LMA insertion by Standard technique and LMA insertion by Two-Person Lateral Rotation Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Benha University Hospital
Banhā
Taghreed Sakr, MD degree of anesthesia, 00201112723187, taghreed.sakr@fmed.bu.edu.eg
About this study
Official 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
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
- Conditions
- LMA, Ventilation
- Being tested
- LMA insertion by Standard technique, LMA insertion by Two-Person Lateral Rotation Technique
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA insertion by Standard techniqueDevice
Standard Brain Technique for Laryngeal Mask Airway Placement
LMA insertion by Two-Person Lateral Rotation TechniqueDevice
Novel Two-Person Lateral Rotation Technique of LMA insertion
| Study group | Role | What they receive |
|---|---|---|
| standard group | Placebo comparator | stanedred LMA insertion Receives: Device: LMA insertion by Standard technique |
| 2 persons group | Active comparator | 2 person lateral rotation LMA insertion Receives: Device: LMA insertion by Two-Person Lateral Rotation Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-attempt insertion success rate, defined as successful placement achieving effective ventilation on the first introduction of the LMA into the oral cavity
Measured: 1 minute after LMA insertion
Secondary outcomes (5)
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)
Measured: 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
Measured: 2-3 minutes after induction of anesthesia
Need for manipulations
Chin lift, jaw thrust, head extension, neck flexion, or moderate advancement recorded as binary
Measured: 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
Measured: 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)
Measured: immediate after removal of LMA ,1,2,4,24 hours. post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LMAStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taghreed Elshahat Sakr, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715708
- Sponsor's protocol ID
- RC.14.5.2026
- Acronym
- LMA insertion
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07715708
- Acronym / sponsor ID
- LMA insertion / RC.14.5.2026
- Conditions
- LMA, Ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard group | Placebo comparator | Device: LMA insertion by Standard techniquestanedred LMA insertion |
| 2 persons group | Active comparator | Device: LMA insertion by Two-Person Lateral Rotation Technique2 person lateral rotation LMA insertion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMA insertion by Standard techniqueStandard Brain Technique for Laryngeal Mask Airway Placement | Device | standard group |
| LMA insertion by Two-Person Lateral Rotation TechniqueNovel Two-Person Lateral Rotation Technique of LMA insertion | Device | 2 persons group |
Primary outcome
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
5 secondary outcomes
Insertion time
Time frame: 20-90 seconds from picking up the LMA to be inserted in the mouth
Number of attempts
Time frame: 2-3 minutes after induction of anesthesia
Need for manipulations
Time frame: 1-2 minutes after induction of anesthesia
Oropharyngeal leak pressure (OLP)
Time frame: 1-2 minutes after insertion of LMA
Complications:
Time frame: immediate after removal of LMA ,1,2,4,24 hours. post operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for LMA
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruiting
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
Airway Management, Anesthesia, General
Not yet recruiting
Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
Perioperative Hypothermia, Hernia, Inguinal
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA insertion by Standard technique and LMA insertion by Two-Person Lateral Rotation Technique in people with LMA and Ventilation, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.