Clinical trial NCT04090944: Comparison Between Blind And Ultrasound Guided Laryngeal Mask Airway Insertion
Official title: Comparison Between Blind And Ultrasound Guided Laryngeal Mask Airway Insertion In Adult Patients Undergoing Elective Surgery: A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: the Position of Laryngeal Mask Airway
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Proper position of a laryngeal mask airway (LMA) requires confirmation to ensure the adequacy of laryngeal seal and pulmonary ventilation. This confirmation may help in prevention of the peri-operative airway complication and ventilation events associated with LMA placement

Detailed description: It is common practice to inflate the cuff of LMA with the maximum recommended volume (size 3, 20 ml; size 4, 30 ml; size 5, 40 ml), as illustrated in several studies , but it may become more rigid which may cause displacement of the LMA and decreases the airway sealing of LMA, more pressure on pharyngeal mucosa which might cause severe mucosal ischemia leading to post- operative sore throat, dysphagia or hoarseness.

Ultrasonography can reliably confirm correct placement of supraglottic devices like laryngeal mask airway (LMA) and rules out causes of inadequate ventilation , also it was found to be a sensitive in detecting rotational malposition of LMA in children.

the replacement of air with saline in LMA cuffs enable detection of cuffs in the airway allowing visualization of the surrounding structures and tissues as the ultrasound beam can be transmitted through the fluid-filled cuffs without being reflected from air mucosal interface.

the adequacy of LMA position will be confirmed by a fiberoptic laryngoscope (FOL)

Eligibility criteria: Inclusion Criteria:

* Patients aged from 18- 60 years of either sex, ASA physical status I - II, weighting 50-100 kg, who will scheduled for elective surgery under general anesthesia.

Exclusion Criteria:

* - Patients whom LMA is contraindicated as patients who are at an increased risk of gastric aspiration as (obstetrics, hiatal hernia or esophageal reflux ), patients with high airway resistance e.g. (bronchospasm or pulmonary edema), patients with low pulmonary compliance e.g. (obesity), cases of an inability to open the mouth or an infection or pathologic abnormality within the oral cavity or pharynx and nonsupine position of operation .
* Patients with a known or predicted difficult airway as patients with class III and IV Modified Mallampati Score or with score \> 5 wilson's risk score.
* Patients with cardiovascular disease (congestive heart failure, coronary artery disease), history of renal or hepatic insufficiency, and endocrinal Diseases will be excluded from the study.

Primary outcomes:
measure: the Score of the fibreoptic view of the larynx
timeFrame: from the clinical judgement of correct position (as ventilation without substantial leak at an airway pressure ≤20 cm H2O, observation of EtCO2 trace )up to 120 second
Secondary outcomes:
Other outcomes:
Locations:
city: Beni-suef
country: Egypt
facility: Beni-suef University Hospital
Study officials:
affiliation: lecturer in anesthesia
name: mohammed abd moselhy, MD
role: PRINCIPAL_INVESTIGATOR
References: