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

NCT04106635 | Completed

• 1 other identifier: MED-INT-19-361
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia; Pulmonary Aspiration

Keywords

Laryngeal mask airway; Paratracheal esophageal pressure; Cricoid pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• The grade of fiberoptic bronchoscopic view

  During induction of anesthesia, an average of 5 minutes

• The time for successful insertion of the device

  : During induction of anesthesia, an average of 60 seconds

• Peak inspiratory pressure

  At 5 minute after insertion of laryngeal mask airway

• The ease of insertion of device

  During induction of anesthesia, an average of 60 seconds

• The number of attempts at insertion of device

  During induction of anesthesia, an average of 60 seconds

Study Arms (2)

PP group

EXPERIMENTAL

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

CP group

ACTIVE COMPARATOR

During the induction of anesthesia, cricoid pressure is applied by 30N force with three finger.

Procedure: Cricoid pressure

Interventions

Paratracheal pressure PROCEDURE

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.

PP group

Cricoid pressure PROCEDURE

To apply cricoid pressure, the cricoid cartilage is compressed by 30N force with a single-handed three finger maneuvre towards the vertebral bodies.

CP group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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),

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou university hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The group assignments were sealed in opaque envelopes by a research assistant not involved in the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized double blinded clinical trial

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: January 2, 2020
• Primary Completion: July 17, 2020
• Study Completion: July 17, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)