Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of the Videolaryngoscopes With Manual In-line Stabilization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02647606
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Go Un Roh, Ajou University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Oral Surgery Maxillofacial Surgery Procedure: MILS Device: McGrath videolaryngoscope Device: Pentax AWS videolaryngoscope Device: Macintosh laryngoscope Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of the McGrath Videolaryngoscope and the Pentax-AWS With the Macintosh Laryngoscope for Nasotracheal Intubation in Patients With Manual In-line Stabilization
Actual Study Start Date : January 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: McGrath Group
MgGrath videolaryngoscope will be used for nasotracheal intubation with MILS
Procedure: MILS
MILS(Manual in-line stabilization) will be applied during intubation. With MILS, different kinds of laryngoscope will be evaluated in a simulated difficult airway.

Device: McGrath videolaryngoscope
McGrath videolaryngoscope will be used for intubation

Experimental: Pentax-AWS Group
Pentax-AWS videolaryngoscope will be used for nasotracheal intubation with MILS
Procedure: MILS
MILS(Manual in-line stabilization) will be applied during intubation. With MILS, different kinds of laryngoscope will be evaluated in a simulated difficult airway.

Device: Pentax AWS videolaryngoscope
Pentax AWS videolaryngoscope will be used for intubation

Experimental: Macintosh Laryngoscope Group
Macintosh Laryngoscope will be used for nasotracheal intubation with MILS
Procedure: MILS
MILS(Manual in-line stabilization) will be applied during intubation. With MILS, different kinds of laryngoscope will be evaluated in a simulated difficult airway.

Device: Macintosh laryngoscope
Macintosh laryngoscope will be used for intubation




Primary Outcome Measures :
  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 Outcome Measures :
  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).




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647606


Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Go Un Roh, MD Ajou University School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Go Un Roh, principal investigator, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02647606    
Other Study ID Numbers: AJIRB-MED-DE1-15-334
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No