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Completed

NCT Number: NCT03169556

Comparison of Conventional Lightwand Intubation Versus Video-laryngoscope Guided Lightwand Intubation in Simulated Cervical Spine-immobilized Patients

Among advanced intubation equipment for difficult intubation, a lighted stylet (lightwand) is a widely used equipment in cervical immobilized patients. However, a lightwand, which is used blind, is difficult to make midline positioning and can increase airway complications and hemodynamic changes. In contrast, videolaryngoscope can view vocal cord indirectly through camera, however, it requires cervical movement. Therefore, investigator hypothesized that the combined use of video-laryngoscope and lightwand for intubation can improve the efficacy of intubation compared to the use of lightwand alone in cervical immobilized patients.

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Key information

Conditions

General Anesthesia

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged between 20- 80 yrs
  • Patients scheduled surgery under the general anesthesia

Exclusion criteria

  • Patient who has history of gastro-esophageal reflux disease, previous airway surgery, anatomical abnormality in the upper airway, or coagulopathy
  • Patients with body mass index >35kg/m2, hemodynamic instability or loosening teeth
  • Patient who disagrees to participate this study or lacks decision-making ability, illiteracy, or foreigner
  • American Society of Anesthesiologists physical status ≥ 3

Treatment and study plan

Video-laryngoscope guided lightwand

Device

After anesthetic induction,the difficult airway is simulated by wearing a semi-hard neck collar. For intubation, video-laryngoscope is inserted into the oral cavity ntil the epiglottis tip was visible without lifting the epiglottic vallecula. Then, the endotracheal tube with lightwand is inserted toward the midline under the epiglottis and the intubation is performed looking the transilluminated light of lightwand.

Other names: Video laryngoscope (VL310, Zhejiang UE Medical, Zhejiang, China)

lightwand alone

Device

After anesthetic induction,the difficult airway is simulated by wearing a semi-hard neck collar. Then, the endotracheal tube with lightwand is inserted and the intubation is performed with conventional method (blind technique by confirming transillumination).

Other names: LightWand (3960, GE Healthcare, Englewood, USA)

Primary outcomes

  1. The success rate of intubation

    Time frame: Within 90 sec after insertion of lightwand or video-laryngosocpe into oral cavity.

    Confirm the success intubation through end-tidal carbon dioxide on a capnography

  2. The duration of intubation

    Time frame: Within 90 sec after insertion of lightwand or video-laryngosocpe into oral cavity.

    Define as the duration between insertion of lightwand or video-laryngoscope to oral cavity and removal all intubating devices from oral cavity.

Secondary outcomes

  1. number of intubation trial and scooping movements

    Time frame: during intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time

    The number of intubation tiral and scooping movements during intubation

  2. Blood pressure change

    Time frame: from start of intubation to 5minute after intubation

    The difference between maximum mean blood pressure and minimum blood pressure

  3. Injuries of oral cavity

    Time frame: at immediate after intubation and extubation

    Check any blood in lips, teeth, endotracheal cuff, and oral cavity

  4. Postoperative hoarseness

    Time frame: at 1hr after PACU arrival and 24hr after operation

    Check "Yes or No" through questioning the patient

  5. Postoperative sore throat

    Time frame: at 1hr after PACU arrival and 24hr after operation

    Check using visual analog scale (0-100 points)

  6. Heart rate change

    Time frame: from start of intubation to 5minute after intubation

    The difference between maximum heart rate and minimum minimum heart rate

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 30, 2017
Registry last updated
Oct 30, 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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