Trial Outcomes & Findings for King Vision Video Laryngoscope Versus Glidescope Video Laryngoscope (NCT NCT02324465)

NCT ID: NCT02324465

Last Updated: 2019-04-23

Results Overview

time from the introduction of the laryngoscope into the oral cavity to endotracheal tube reaching the glottic aperture

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: <100 seconds
• Results posted on: 2019-04-23

Participant Flow

Participant milestones

Measure	King Vision Video Laryngoscope The patient would be randomized to intubation via use of the King Vision VL then Glidescope VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope	Glidescope Video Laryngoscope The patient would be randomized to intubation via use of the Glidescope VL then King Vision VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope
Overall Study STARTED	18	22
Overall Study COMPLETED	18	21
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	King Vision Video Laryngoscope The patient would be randomized to intubation via use of the King Vision VL then Glidescope VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope	Glidescope Video Laryngoscope The patient would be randomized to intubation via use of the Glidescope VL then King Vision VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope
Overall Study device failure	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	King Vision Video Laryngoscope n=18 Participants The patient would be randomized to intubation via use of the King Vision VL then Glidescope VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope	Glidescope Video Laryngoscope n=22 Participants The patient would be randomized to intubation via use of the Glidescope VL then King Vision VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=18 Participants	0 Participants n=22 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=18 Participants	18 Participants n=22 Participants	33 Participants n=40 Participants
Age, Categorical >=65 years	3 Participants n=18 Participants	4 Participants n=22 Participants	7 Participants n=40 Participants
Sex: Female, Male Female	10 Participants n=18 Participants	11 Participants n=22 Participants	21 Participants n=40 Participants
Sex: Female, Male Male	8 Participants n=18 Participants	11 Participants n=22 Participants	19 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	18 participants n=18 Participants	22 participants n=22 Participants	40 participants n=40 Participants

PRIMARY outcome

Timeframe: <100 seconds

time from the introduction of the laryngoscope into the oral cavity to endotracheal tube reaching the glottic aperture

Outcome measures

Measure	King Vision Video Laryngoscope n=18 Participants The patient would be randomized to intubation via use of the King Vision VL or Glidescope VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope	Glidescope Video Laryngoscope n=21 Participants The patient would be randomized to intubation via use of the Glidescope VL or King Vision VL Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope
Time Until Intubation With Each Device	32.3 seconds Interval 10.0 to 69.7	27.2 seconds Interval 9.6 to 53.2

SECONDARY outcome

Timeframe: <100 seconds

Outcome measures

Measure	King Vision Video Laryngoscope n=18 Participants The patient would be randomized to intubation via use of the King Vision VL or Glidescope VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope	Glidescope Video Laryngoscope n=21 Participants The patient would be randomized to intubation via use of the Glidescope VL or King Vision VL Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope
Mean Pulse Oximetry Saturation Value Reading During Intubation	97.39 percentage of oxygen saturation Interval 85.0 to 100.0	97.0 percentage of oxygen saturation Interval 82.0 to 100.0

SECONDARY outcome

Timeframe: <100 seconds

Assisted Maneuvers can include laryngeal manipulation, head lift, Backward Upward Rightward Pressure, stylet removed, Cricoid pressure, scope manipulation and bougie.

Outcome measures

Measure	King Vision Video Laryngoscope n=18 Participants The patient would be randomized to intubation via use of the King Vision VL or Glidescope VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope	Glidescope Video Laryngoscope n=21 Participants The patient would be randomized to intubation via use of the Glidescope VL or King Vision VL Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope
Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) Backward Upward Rightward Pressure	0 assisted maneuvers	1 assisted maneuvers
Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) stylet removed	0 assisted maneuvers	1 assisted maneuvers
Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) Cricoid pressure	0 assisted maneuvers	3 assisted maneuvers
Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) bougie	0 assisted maneuvers	1 assisted maneuvers
Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) scope manipulation	0 assisted maneuvers	1 assisted maneuvers

OTHER_PRE_SPECIFIED outcome

Timeframe: during and immediately after procedure (approx 180 minutes)

Notation of any injury to lips, teeth, soft tissue.

Outcome measures

Measure	King Vision Video Laryngoscope n=18 Participants The patient would be randomized to intubation via use of the King Vision VL or Glidescope VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope	Glidescope Video Laryngoscope n=22 Participants The patient would be randomized to intubation via use of the Glidescope VL or King Vision VL Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope
Number of Participants With Adverse Events	2 participants	2 participants

Adverse Events

King Vision Video Laryngoscope

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Glidescope Video Laryngoscope

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	King Vision Video Laryngoscope n=18 participants at risk The patient would be randomized to intubation via use of the King Vision VL or Glidescope VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope	Glidescope Video Laryngoscope n=22 participants at risk The patient would be randomized to intubation via use of the Glidescope VL or King Vision VL Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope
Injury, poisoning and procedural complications Lip Trauma	11.1% 2/18 • Number of events 2 • approximately 180 minutes	9.1% 2/22 • Number of events 2 • approximately 180 minutes

Additional Information

Doug Hester

Vanderbilt University Medical Center

Phone: 6153439419

Email: doug.hester@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place