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Completed

NCT Number: NCT01215695

Video-laryngoscope With a Novel Video-stylet for Difficult Intubation

We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with general anesthesia including endotracheal intubation. Patients qualify for the trial if they are considered a difficult airway case as determined by measurement of common predictive indices for difficult intubation (see inclusion criteria). All patients will be intubated with a GVL. Patients will be randomly assigned to either having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The randomization will be stratified as to whether patients are categorized as predicted difficult airway or have an immobilized cervical spine (C-collar in place).

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Key information

Conditions

Difficult Endotracheal Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI > 35
  • Thyromental distance < 6 cm
  • Sterno-mental distance < 12 cm
  • Mallampati grade 3 and 4
  • Interincisor distance < 38 mm
  • Status of dentition: presence of buckteeth
  • Neck movement < 35°
  • Neck circumference >43 cm at the level of the thyroid cartilage
  • Patients with immobilized cervical spine (C-collar in place).
  • History of difficult laryngoscopy or intubation

Exclusion criteria

  • Full stomach
  • Hiatal hernia
  • Severe GERD (Gastroesophageal reflux disease)
  • Tumors of the upper airway

Treatment and study plan

aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)

Device

The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.

Other names: video-stylet

Control

Device

pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope

Primary outcomes

  1. Intubation Time

    Time frame: 120 seconds

    divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above). Interim bag and mask time, if needed, will not be included in the intubation time. More than 5 attempts or 120 s are regarded as failure of intubation. If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.

Secondary outcomes

  1. The Number of Intubation Attempts

    Time frame: 30 minutes

    counted as each approach of the ETT to the glottic entrance.

  2. Neck Movement

    Time frame: 30 minutes

    One observer will video-record the entire intubation procedure. At a later time, an otherwise unrelated observer will watch the video-records and grade the neck movement during intubation. Neck movement will be classified as Grade 0: no neck movement, Grade 1: minimal neck movement, or Grade 2: moderate neck movement. Results are reported as total with mild, moderate, or severe neck movement.

  3. Laryngeal View Grade of 1 or 2

    Time frame: 30 minutes

    The laryngeal view as Grade 1 (full view of the glottis) or Grade 2 (glottis partly exposed, anterior commissure not seen) according to the method described by Cormack and Lehane (1984).

  4. Ease of Intubation

    Time frame: 2-4 hours after intubation

    After completion of the procedure the intubator will be asked to score the ease of intubation. To do this, he/she will give a score from 0-100 with 0 being the easiest and 100 being the hardest.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Feasibility of a Combined Use of a Video-laryngoscope With a Novel Video-stylet for Predicted Difficult Intubation

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 6, 2010
Registry last updated
Sep 8, 2017

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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