Paratracheal Esophagus Pressure on the Intubation With Pentax Airway Scope

NCT ID: NCT04135651

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

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-09

Study Completion Date

2020-04-03

Brief Summary

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Recently, left paratracheal pressure was introduced as an alternative method to prevent pulmonary aspiration instead of cricoid pressure. Criocoid pressure is known to worsen glottic visibility when using Pentax.However, the effects of left paratracheal pressure on glottic view when using Pentax are not studied yet. In this study, the subjects are divided into two groups (group I: left paratracheal pressure applied before intubation, group II: conventional cricoid pressure applied before intubation). Investigators will assess the glottic view during intubation using Pentax.

Detailed Description

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Primary outcome

\- Duration of intubation

Secondary outcomes

* POGO (percentage of glottic opening) score before and after application of each intervention
* Glottic grade by Cormack Lehane
* The success rate in first attempt
* Intubation difficulty scale
* Hemodynamics during intubation
* Postoperative airway complications

Conditions

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Anesthesia Intubation; Difficult or Failed Cricoid Pressure Pulmonary Aspiration During Anesthetic Induction

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.

The interventional process covers opaque clothes.

Study Groups

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Paralaryngeal pressure

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.

Cricoid pressure

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

Group Type ACTIVE_COMPARATOR

Cricoid pressure

Intervention Type PROCEDURE

To apply cricoid pressure, the crocoid cartilage was compressed 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 crocoid cartilage was compressed 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
* 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-19-340

Identifier Type: -

Identifier Source: org_study_id

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