Effect of Paratracheal Esophagus Pressure on the Insertion of Laryngeal Mask Airway

General Anesthesia Clinical Trial

Official title:

Effect of Pressure to Left Paratracheal Esophagus During the Insertion of Laryngeal Mask Airway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106635
• Other study ID #: MED-INT-19-361
• Status: Completed
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: July 17, 2020

Study information

• Verified date: January 2021
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Laryngeal mask airway is inserted into the oral cavity and seals the upper esophagus and the surrounding tissue, effectively securing airway. Laryngeal mask airway has been widely adopted in the clinical practice. On the other hand, cricoid pressure has been used to reduce the risk of pulmonary aspiration of gastric contents during induction of general anesthesia. However, cricoid pressure might impede placement of the laryngeal mask airway, thereby preventing effective ventilation. Recently, left paratracheal pressure was introduced as an alternative to cricoid pressure and reported to be more effective than cricoid pressure in the prevention of gastric air insufflation during positive-pressure ventilation by facemask. Since this method compresses low left paratracheal level, it may affect the successful insertion of laryngeal mask airway. In this study, the investigators aimed to evaluate the effect of paratracheal esophagus pressure on the insertion of laryngeal mask airway compare to conventional cricoid pressure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 17, 2020
• Est. primary completion date: July 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients who are undergoing surgery under general anesthesia where supraglottic airway management will be appropriate
• American Society of Anesthesiologists Classification 1-2

Exclusion Criteria:

• Body mass index > 35 kg/m2
• High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)
• Criteria for difficult airway (limitation of mouth opening/neck extension, Mallampati class IV),

Related Conditions & MeSH terms

• General Anesthesia
• Pulmonary Aspiration

Intervention

Procedure:
• Paratracheal pressure
To apply paratracheal pressure, the thumb was placed over the left side of the trachea cephalad to the clavicle and medial to the sternocleidomastoid muscle.
• Cricoid pressure
To apply cricoid pressure, the cricoid cartilage is compressed by 30N force with a single-handed three finger maneuvre towards the vertebral bodies.

Locations

Country	Name	City	State
Korea, Republic of	Ajou university hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of device insertion	Successful insertion of laryngeal mask airway in a maximum of three attempts	During induction of anesthesia, an average of 60 seconds
Secondary	The grade of fiberoptic bronchoscopic view	The fiberoptic bronchoscopic view is defined as Grade 1, larynx only seen; Grade 2, larynx and epiglottis posterior surface seen; Grade 3, larynx, and epiglottis tip or anterior surface seen-visual obstruction of epiglottis to larynx: < 50%; Grade 4, epiglottis down-folded, and its anterior surface seen-visual obstruction of epiglottis to larynx: > 50%; Grade 5, epiglottis downfolded and larynx cannot be seen directly.	During induction of anesthesia, an average of 5 minutes
Secondary	The time for successful insertion of the device	The total time is measured from the removal of the face mask until bilateral chest rise with the first capnogram upstroke.	: During induction of anesthesia, an average of 60 seconds
Secondary	Peak inspiratory pressure	Peak inspiratory pressure is recorded from mechanical ventilator.	At 5 minute after insertion of laryngeal mask airway
Secondary	The ease of insertion of device	The ease of placement was assessed using a subjective scale of 1-4 (1= no resistance, 2 = moderate resistance, 3 = high resistance, 4 = inability to place the device	During induction of anesthesia, an average of 60 seconds
Secondary	The number of attempts at insertion of device	The number of attempts for successful insertion of laryngeal mask airway	During induction of anesthesia, an average of 60 seconds
Secondary	Success rate in first attempt	Successful insertion of laryngeal mask airway in a first attempt	: During induction of anesthesia, an average of 60 seconds
Secondary	Incidence of intraoperative complications	Intraoperative complications including coughing, laryngospasm, bronchospasm, hypoxia (SpO2 < 90%), regurgitation, aspiration, blood staining of the device.	During the surgery, an average of 2 hours after anesthesia induction
Secondary	Incidence of postoperative complications	Postoperative complications including sore throat, hoarseness/dysphonia, jaw, neck or ear pain, persistent cough, tachypnea, stridor, hypoxia (SpO2 < 90%), nausea and vomiting.	An average of 2 hours after extubation
Secondary	The presence of gastric air insufflation after induction of anesthesia	The presence of gastric air insufflation is defined as an increase in antral cross-sectional area and/or presence of air artifacts in the antrum (comet tail, posterior acoustic shadow) confirmed by ultrasound.	During induction of anesthesia, an average of 5 minutes