Comparison Between Blind And Ultrasound Guided Laryngeal Mask Airway Insertion

the Position of Laryngeal Mask Airway Clinical Trial

Official title:

Comparison Between Blind And Ultrasound Guided Laryngeal Mask Airway Insertion In Adult Patients Undergoing Elective Surgery: A Randomized Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04090944
• Other study ID #: Beni-suef Hospital
• Status: Recruiting
• Phase: Phase 1
• Start date: October 2019
• Est. completion date: March 2020

Study information

• Verified date: September 2019
• Source: Beni-Suef University
• Contact: mohammed abd moselhy, MD
• Phone: 0201145504361
• Email: mohamed_abdelkader[@]med.bsu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• the Position of Laryngeal Mask Airway

Intervention

Procedure:
• the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) for confirmation of LMA position
-The position of LMA will be assessed by another anesthetist (blinded assessor) using the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) per the grading licensed by Aoyama et al.

Locations

Country	Name	City	State
Egypt	Beni-suef University Hospital	Beni-suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Score of the fibreoptic view of the larynx	the aim of this study is to compare between the blind technique and US guided technique of laryngeal mask airway insertion regarding the position as confirmed by the fiberoptic laryngoscope.	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