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NCT Number: NCT04135651

Paratracheal Esophagus Pressure on the 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.

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Key information

Conditions

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

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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),

Treatment and study plan

Paratracheal pressure

Procedure

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

Procedure

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

Primary outcomes

  1. Time to intubation

    Time frame: During anesthesia induction procedure

    The duration from when Pentax pass the tooth to confirm the successful intubation using capnography

Secondary outcomes

  1. The percentage of glottic opening (POGO) score

    Time frame: During anesthesia induction procedure

    The percentage of glottic opening (POGO), linear span from the anterior commissure to the interarytenoid notch, 0-100%

  2. Cormack-Lehane grade

    Time frame: 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)

  3. Intubation difficulty scale (IDS)

    Time frame: 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).

  4. Intubation difficulty by NRS score

    Time frame: During anesthesia induction procedure

    Intubation difficulty by NRS score (0=easy, 10=the most difficult)

  5. Success rate in first attempt

    Time frame: During anesthesia induction procedure

    Successful intubation in a first attempt

  6. Hemodynamic changes

    Time frame: During anesthesia induction procedure

    Blood pressure (mmHg) at 4 time points: Baseline, 1 minute after injection of anesthetic drugs, immediately before intubation, and 1 minute after intubation

  7. Hemodynamic changes

    Time frame: 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

  8. Postoperative complications

    Time frame: An average of 1 hours after extubation

    Postoperative complications including sore throat, hoarseness/dysphonia, or pharyngeal pain

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2019
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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