Paratracheal Esophagus Pressure on the Intubation With Pentax Airway Scope

Study Overview
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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

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

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

Intervention / Treatment
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* Procedure: Paratracheal pressure
* Procedure: Cricoid pressure


Participation Criteria
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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),

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized double blinded clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paralaryngeal pressure<br>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<br>* 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.<br>|
| Active Comparator: Cricoid pressure<br>During the induction of anesthesia, cricoid pressure is applied by 30N force with three fingers. | Procedure: Cricoid pressure<br>* To apply cricoid pressure, the crocoid cartilage was compressed with a single-handed three-finger maneuvre towards the vertebral bodies.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pentax, Paratracheal pressure, Glottic view, Cricoid pressure