Paratracheal Esophagus Pressure on the Intubation With Pentax Airway Scope

Not Applicable

Completed

• Conditions: Intubation; Difficult or Failed; Cricoid Pressure; Pulmonary Aspiration During Anesthetic Induction; Anesthesia
• Interventions: Procedure: Cricoid pressure; Procedure: Paratracheal pressure

• Registration Number: NCT04135651
• Lead Sponsor: Ajou University School of Medicine

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.

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 Timeline

• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-20
• Study First Posted: 2019-10-22
• Study Start: 2019-12-09
• Primary Completion: 2020-04-02
• Study Completion: 2020-04-03
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cricoid pressure	Cricoid pressure	During the induction of anesthesia, cricoid pressure is applied by 30N force with three fingers.
Paralaryngeal pressure	Paratracheal 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.

Primary Outcome Measures

Name	Time	Method
Time to intubation	During anesthesia induction procedure	The duration from when Pentax pass the tooth to confirm the successful intubation using capnography

Secondary Outcome Measures

Name	Time	Method
The percentage of glottic opening (POGO) score	During anesthesia induction procedure	The percentage of glottic opening (POGO), linear span from the anterior commissure to the interarytenoid notch, 0-100%
Cormack-Lehane grade	During anesthesia induction procedure	The grade of glottic opening by intubation device (1= Full view of glottis, easy; 4=Neither glottis nor epiglottis seen, difficult)
Postoperative complications	An average of 1 hours after extubation	Postoperative complications including sore throat, hoarseness/dysphonia, or pharyngeal pain
Intubation difficulty scale (IDS)	During anesthesia induction procedure	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).
Hemodynamic changes	During anesthesia induction procedure	Heart rate (bpm) at 4 time points: Baseline, 1 minute after injection of anesthetic drugs, immediately before intubation, and 1 minute after intubation
Intubation difficulty by NRS score	During anesthesia induction procedure	Intubation difficulty by NRS score (0=easy, 10=the most difficult)
Success rate in first attempt	During anesthesia induction procedure	Successful intubation in a first attempt

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of