Paratracheal Esophagus Pressure on the Intubation With Pentax Airway Scope

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04135651
• Other study ID #: MED-INT-19-340
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: April 3, 2020

Study information

• Verified date: January 2021
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: April 3, 2020
• Est. primary completion date: April 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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),

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to intubation	The duration from when Pentax pass the tooth to confirm the successful intubation using capnography	During anesthesia induction procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	Intubation difficulty by NRS score	Intubation difficulty by NRS score (0=easy, 10=the most difficult)	During anesthesia induction procedure
Secondary	Success rate in first attempt	Successful intubation in a first attempt	During anesthesia induction procedure
Secondary	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
Secondary	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
Secondary	Postoperative complications	Postoperative complications including sore throat, hoarseness/dysphonia, or pharyngeal pain	An average of 1 hours after extubation