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Completed

NCT Number: NCT03841890

The Clarus Video System and Direct Laryngoscope for Rapid Sequence Induction Intubation With Cricoid Pressure

During an emergency endotracheal intubation, rapid sequence induction intubation with cricoid pressure is frequently implemented to prevent aspiration pneumonia. When properly applied, cricoid pressure may not affect glottic view during endotracheal intubation with either a direct laryngoscope or a video laryngoscope. However, the application of cricoid pressure is likely to prolong the intubation time. Limited mouth opening or vulnerable teeth, which often accompany the patients requiring emergency intubation, are the two common factors to deter the intubators from using a laryngoscopic device. Besides, the blade of a laryngoscopic device is often too bulky for a narrow mouth opening, and the blade always bears a level force on upper incisors while the intubator is lifting epiglottis during intubation, which is liable to tooth fracture. In this prospective randomized study, the investigators compare the use of the Clarus Video System and that of direct laryngoscope (Macintosh Laryngoscope) in patients undergoing endotracheal intubation in simulated rapid sequence induction intubation for the primary goals of the first attempt success rate and intubation time.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Older than 20 years of age
  • Scheduled for elective surgery under general anesthesia

Exclusion criteria

  • BMI (Body Mass Index) > 35 kg/m2
  • Interincisor distance < 3 cm
  • Poor dentition
  • Upper airway tumor
  • Limited neck mobility
  • Pregnancy
  • History of difficult tracheal intubation

Treatment and study plan

the Clarus Video System as a video stylet

Device

video-guided intubation

Other names: Trachway as a video stylet

the Clarus Video System as a lightwand

Device

The endotracheal tube will be initially guided into larynx in the dimly lit operating room by a bright glow moving in the anterior soft tissue of the neck and finally by the image of the trachea rings on the video screen.

Other names: Trachway as a lightwand

Direct Laryngoscope

Device

Macintosh laryngoscope size 3

Primary outcomes

  1. The first attempt success rate

    Time frame: After intubation immediately

  2. Intubation time

    Time frame: After intubation immediately

    Intubation time was counted from the inserting the device into the patient's mouth to viewing the endotracheal tube into the trachea.

Secondary outcomes

  1. Blood pressure

    Time frame: 1 minute and 5 minutes after intubation

    Measure blood pressure in millimeter of mercury by non-invasive blood pressure before induction, 1 minute after intubation, and 5 minutes after intubation

  2. Heart rate

    Time frame: 1 minute and 5 minutes after intubation

    Measure heart rate in beats per minute by electrocardiography monitor before induction, 1 minute after intubation, and 5 minutes after intubation

  3. Sore throat

    Time frame: On postoperative day 1

    Documented by a blinded observer on the next day. Sore throat was graded according to numerical rating scale (NRS): none, NRS = 0; mild, NRS = 1-3; moderate, NRS = 4-6; severe, NRS = 7-10.

  4. Mucosal injury

    Time frame: On postoperative day 1

    Documented by a blinded observer on the next day. "Yes" is defined as any oral mucosal lesion reported by participants.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

The Clarus Video System (Trachway) and Direct Laryngoscope for Endotracheal Intubation With Cricoid Pressure in Simulated Rapid Sequence Induction Intubation: A Prospective Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2019
Registry last updated
Feb 15, 2019

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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