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Paratracheal Esophagus Pressure on the Intubation With Pentax Airway Scope

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04135651
Enrollment
94
Registered
2019-10-22
Start date
2019-12-09
Completion date
2020-04-03
Last updated
2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Paratracheal pressure, Glottic view, Cricoid pressure, Pentax

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

Interventions

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.

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

Sponsors

Ajou University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The group assignments were sealed in opaque envelopes by a research assistant not involved in the study. The interventional process covers opaque clothes.

Intervention model description

Randomized double blinded clinical trial

Eligibility

Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No

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),

Design outcomes

Primary

MeasureTime frameDescription
Time to intubationDuring anesthesia induction procedureThe duration from when Pentax pass the tooth to confirm the successful intubation using capnography

Secondary

MeasureTime frameDescription
Cormack-Lehane gradeDuring anesthesia induction procedureThe grade of glottic opening by intubation device (1= Full view of glottis, easy; 4=Neither glottis nor epiglottis seen, difficult)
Intubation difficulty scale (IDS)During anesthesia induction procedureThe 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).
Intubation difficulty by NRS scoreDuring anesthesia induction procedureIntubation difficulty by NRS score (0=easy, 10=the most difficult)
The percentage of glottic opening (POGO) scoreDuring anesthesia induction procedureThe percentage of glottic opening (POGO), linear span from the anterior commissure to the interarytenoid notch, 0-100%
Hemodynamic changesDuring anesthesia induction procedureBlood pressure (mmHg) at 4 time points: Baseline, 1 minute after injection of anesthetic drugs, immediately before intubation, and 1 minute after intubation
Postoperative complicationsAn average of 1 hours after extubationPostoperative complications including sore throat, hoarseness/dysphonia, or pharyngeal pain
Success rate in first attemptDuring anesthesia induction procedureSuccessful intubation in a first attempt

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026