Paratracheal Esophagus Pressure on the Intubation With Pentax Airway Scope

Effect of Paratracheal Esophagus Pressure on the Endotracheal Intubation With Pentax Airway Scope

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Intubation; Difficult or Failed; Cricoid Pressure; Pulmonary Aspiration During Anesthetic Induction
• Intervention / Treatment: Procedure: Paratracheal pressure; Procedure: Cricoid pressure

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 94
• 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
• 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 Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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: Cricoid pressure; During the induction of anesthesia, cricoid pressure is applied by 30N force with three fingers.	Procedure: Cricoid pressure; To apply cricoid pressure, the crocoid cartilage was compressed 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
Time to intubation	The duration from when Pentax pass the tooth to confirm the successful intubation using capnography	During anesthesia induction procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of glottic opening (POGO) score	The percentage of glottic opening (POGO), linear span from the anterior commissure to the interarytenoid notch, 0-100%	During anesthesia induction procedure
Cormack-Lehane grade	The grade of glottic opening by intubation device (1= Full view of glottis, easy; 4=Neither glottis nor epiglottis seen, difficult)	During anesthesia induction procedure
Intubation difficulty scale (IDS)	The intubation difficulty scale by the sum of seven variables (N1-N7). N1= the number of additional intubation attempts, N2= the number of additional operators, N3= the number of alternative intubation techniques used, N4= the laryngoscopic view, as defined by Cormack and Lehane, N5= the lifting force applied during laryngoscopy, N6= to the necessity to apply external laryngeal pressure to optimize glottic exposure, N7= vocal cord mobility. The IDS score is the sum of N1 through N7. The total IDS score ranges from zero (easy) to infinity (difficult).	During anesthesia induction procedure
Intubation difficulty by NRS score	Intubation difficulty by NRS score (0=easy, 10=the most difficult)	During anesthesia induction procedure
Success rate in first attempt	Successful intubation in a first attempt	During anesthesia induction procedure
Hemodynamic changes	Blood pressure (mmHg) at 4 time points: Baseline, 1 minute after injection of anesthetic drugs, immediately before intubation, and 1 minute after intubation	During anesthesia induction procedure
Hemodynamic changes	Heart rate (bpm) at 4 time points: Baseline, 1 minute after injection of anesthetic drugs, immediately before intubation, and 1 minute after intubation	During anesthesia induction procedure
Postoperative complications	Postoperative complications including sore throat, hoarseness/dysphonia, or pharyngeal pain	An average of 1 hours after extubation

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Actual): April 2, 2020
• Study Completion (Actual): April 3, 2020

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 20, 2019
• First Posted (Actual): October 22, 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: Cricoid pressure; Glottic view; Paratracheal pressure; Pentax
• Other Study ID Numbers: MED-INT-19-340

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