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

NCT ID: NCT04106635

Last Updated: 2021-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-02

Study Completion Date

2020-07-17

Brief Summary

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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.

Detailed Description

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Conditions

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General Anesthesia Pulmonary Aspiration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized double blinded clinical trial
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The group assignments were sealed in opaque envelopes by a research assistant not involved in the study.

Study Groups

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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.

Group Type EXPERIMENTAL

Paratracheal pressure

Intervention Type 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.

CP group

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

Group Type ACTIVE_COMPARATOR

Cricoid pressure

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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),
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jong Yeop Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ajou university hospital

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MED-INT-19-361

Identifier Type: -

Identifier Source: org_study_id

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