LMA, Ventilation
Conditions
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
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
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* \- 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Egypt
Outcome results
None listed