Clinical trial NCT04106635: Effect of Paratracheal Esophagus Pressure on the Insertion of Laryngeal Mask Airway
Official title: Effect of Pressure to Left Paratracheal Esophagus During the Insertion of Laryngeal Mask Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Pulmonary Aspiration
Keywords: Laryngeal mask airway
Paratracheal esophageal pressure
Cricoid pressure
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 108
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double blinded clinical trial
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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),

Primary outcomes:
measure: The success rate of device insertion
timeFrame: During induction of anesthesia, an average of 60 seconds
Secondary outcomes:
measure: The grade of fiberoptic bronchoscopic view
timeFrame: During induction of anesthesia, an average of 5 minutes
measure: The time for successful insertion of the device
timeFrame: : During induction of anesthesia, an average of 60 seconds
measure: Peak inspiratory pressure
timeFrame: At 5 minute after insertion of laryngeal mask airway
measure: The ease of insertion of device
timeFrame: During induction of anesthesia, an average of 60 seconds
measure: The number of attempts at insertion of device
timeFrame: During induction of anesthesia, an average of 60 seconds
measure: Success rate in first attempt
timeFrame: : During induction of anesthesia, an average of 60 seconds
measure: Incidence of intraoperative complications
timeFrame: During the surgery, an average of 2 hours after anesthesia induction
measure: Incidence of postoperative complications
timeFrame: An average of 2 hours after extubation
measure: The presence of gastric air insufflation after induction of anesthesia
timeFrame: During induction of anesthesia, an average of 5 minutes
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou university hospital
state: Gyeonggi-do
Study officials:
References: