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Completed

NCT Number: NCT02647606

Comparison of the Videolaryngoscopes With Manual In-line Stabilization

Videolaryngoscope is useful to improve the laryngeal view, especially during difficult intubation. There are several kinds of videolaryngoscopes and it is applicable during nasotracheal intubation. In this study, the investigators will compare the McGrath videolaryngoscope and Pentax-AWS with Macintosh laryngoscope for nasotracheal intubation in patients with manual in-line stabilization.

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Key information

Conditions

Oral Surgery Maxillofacial Surgery

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • oral or maxillofacial surgery
  • ASA class I, II

Exclusion criteria

  • anticipated difficult intubation
  • necessity for rapid sequence induction
  • cervical spine injury
  • bleeding tendency

Treatment and study plan

MILS

Procedure

MILS(Manual in-line stabilization) will be applied during intubation. With MILS, different kinds of laryngoscope will be evaluated in a simulated difficult airway.

McGrath videolaryngoscope

Device

McGrath videolaryngoscope will be used for intubation

Pentax AWS videolaryngoscope

Device

Pentax AWS videolaryngoscope will be used for intubation

Macintosh laryngoscope

Device

Macintosh laryngoscope will be used for intubation

Primary outcomes

  1. time for intubation

    Time frame: from holding the laryngoscope until the 1st ventilation after intubation, within 90 seconds

  2. Cormack Lehane Laryngeal view

    Time frame: when laryngoscope is appropriately placed during intubation, approximately 2 seconds

  3. POGP score

    Time frame: when laryngoscope is appropriately placed during intubation, approximately 2 seconds

    Percentage of glottic opening(POGO)

Secondary outcomes

  1. external laryngeal manipulation

    Time frame: when laryngoscope is appropriately placed during intubation, approximately 2 seconds

    When the laryngeal view is insufficient during laryngoscope, another physician can manipulate the larynx externally to improve the laryngeal view. The necessity of external laryngeal manipulation will be recorded.

  2. magill forceps

    Time frame: when laryngoscope is appropriately placed during intubation, approximately 5 seconds

    when the nasotracheal tube can not introduced to vocal cord manually, magill forceps can hold the tube to advance the tube through vocal cord. The necessity of magill forceps during intubation will be recorded

  3. IDS (intubation difficulty scale)

    Time frame: during intubation, approximately 90 seconds

    IDS score is the sum of the following seven variables:

    N1: the number of intubation attempts>1 N2: the number of operators. 1 N3: the number of alternative intubation techniques used N4: glottic exposure (Cormack Lehane grade minus 1) N5: Lifting force required during laryngoscopy (0=normal; 1=increased) N6: necessity for external laryngeal pressure (0=not applied; 1=applied) N7: position of the vocal cords at intubation (0=abduction/ not visualized; 1=adduction)

  4. numeric rating scale for intubation

    Time frame: during intubation, approximately 90 seconds

    0-10 (0; no difficulty, 10: hardest)

  5. grade of bleeding

    Time frame: 10 seconds after completion of intubation

    After confirmation of successful intubation, Yankauer suction was introduced to access the intraoral bleeding during intubation.

    Grade is 4 points scale (none/trace/moderate/severe).

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

Comparison of the McGrath Videolaryngoscope and the Pentax-AWS With the Macintosh Laryngoscope for Nasotracheal Intubation in Patients With Manual In-line Stabilization

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2016
Registry last updated
Nov 6, 2018

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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