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

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

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.

Study Overview

• Status: Completed
• Conditions: General Anesthesia; Pulmonary Aspiration
• Intervention / Treatment: Procedure: Paratracheal pressure; Procedure: Cricoid pressure

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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),

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PP group; During the induction of anesthesia, left paratracheal pressure is applied by 30N force with thumb after confirmation of the location of the esophagus using ultrasound.	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.
ACTIVE_COMPARATOR: CP group; During the induction of anesthesia, cricoid pressure is applied by 30N force with three finger.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Peak inspiratory pressure	Peak inspiratory pressure is recorded from mechanical ventilator.	At 5 minute after insertion of laryngeal mask airway
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
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
Success rate in first attempt	Successful insertion of laryngeal mask airway in a first attempt	: During induction of anesthesia, an average of 60 seconds
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
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
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

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2020
• Primary Completion (ACTUAL): July 17, 2020
• Study Completion (ACTUAL): July 17, 2020

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (ACTUAL): September 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Laryngeal mask airway; Cricoid pressure; Paratracheal esophageal pressure
• Other Study ID Numbers: MED-INT-19-361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No