Paratracheal Esophagus Pressure on the Intubation With Pentax Airway Scope

NCT04135651 | Completed

• 1 other identifier: MED-INT-19-340
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Paratracheal pressure; Glottic view; Cricoid pressure; Pentax

Outcome Measures

Primary Outcomes (1)

• Time to intubation

  The duration from when Pentax pass the tooth to confirm the successful intubation using capnography

  During anesthesia induction procedure

Secondary Outcomes (8)

• The percentage of glottic opening (POGO) score

  During anesthesia induction procedure

• Cormack-Lehane grade

  During anesthesia induction procedure

• Intubation difficulty scale (IDS)

  During anesthesia induction procedure

• Intubation difficulty by NRS score

  During anesthesia induction procedure

• Success rate in first attempt

  During anesthesia induction procedure

Study Arms (2)

Paralaryngeal pressure

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

Cricoid pressure

ACTIVE COMPARATOR

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

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.

Paralaryngeal pressure

Cricoid pressure PROCEDURE

To apply cricoid pressure, the crocoid cartilage was compressed with a single-handed three-finger maneuvre towards the vertebral bodies.

Cricoid pressure

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
• 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. The interventional process covers opaque clothes.
• 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: October 15, 2019
• First Posted: October 22, 2019
• Study Start: December 9, 2019
• Primary Completion: April 2, 2020
• Study Completion: April 3, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)