Trial Outcomes & Findings for Nasal Intubation Using King Vision Video Laryngoscopy (NCT NCT03126344)

NCT ID: NCT03126344

Last Updated: 2020-09-14

Results Overview

the interval between opening the mouth and the time when three consecutive end-tidal CO2 waves were appeared on the monitor

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 99 participants
• Primary outcome timeframe: 0 min after nasal intubation
• Results posted on: 2020-09-14

Participant Flow

Participant milestones

Measure	King Vision Video Laryngoscope King Vision video laryngoscope: nasal intubation using King Vision video laryngoscope Device after general anesthesia induction	McGrath MAC Video Laryngoscope McGrath MAC video laryngoscope: nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction	Macintosh Macintosh laryngoscope: nasal intubation using Macintosh laryngoscope Device after general anesthesia induction
Overall Study STARTED	33	33	33
Overall Study COMPLETED	33	33	28
Overall Study NOT COMPLETED	0	0	5

Reasons for withdrawal

Measure	King Vision Video Laryngoscope King Vision video laryngoscope: nasal intubation using King Vision video laryngoscope Device after general anesthesia induction	McGrath MAC Video Laryngoscope McGrath MAC video laryngoscope: nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction	Macintosh Macintosh laryngoscope: nasal intubation using Macintosh laryngoscope Device after general anesthesia induction
Overall Study Lost to Follow-up	0	0	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	King Vision Video Laryngoscope n=33 Participants King Vision video laryngoscope: nasal intubation using King Vision video laryngoscope Device after general anesthesia induction	McGrath MAC Video Laryngoscope n=33 Participants McGrath MAC video laryngoscope: nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction	Macintosh n=33 Participants Macintosh laryngoscope: nasal intubation using Macintosh laryngoscope Device after general anesthesia induction	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=33 Participants	0 Participants n=33 Participants	0 Participants n=33 Participants	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=33 Participants	33 Participants n=33 Participants	33 Participants n=33 Participants	99 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=33 Participants	0 Participants n=33 Participants	0 Participants n=33 Participants	0 Participants n=99 Participants
Age, Continuous	38 year STANDARD_DEVIATION 12 • n=33 Participants	36 year STANDARD_DEVIATION 11 • n=33 Participants	40 year STANDARD_DEVIATION 11 • n=33 Participants	38 year STANDARD_DEVIATION 11 • n=99 Participants
Sex: Female, Male Female	15 Participants n=33 Participants	19 Participants n=33 Participants	16 Participants n=33 Participants	50 Participants n=99 Participants
Sex: Female, Male Male	18 Participants n=33 Participants	14 Participants n=33 Participants	17 Participants n=33 Participants	49 Participants n=99 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	33 participants n=33 Participants	33 participants n=33 Participants	33 participants n=33 Participants	99 participants n=99 Participants
BMI	22 Kg/M^2 STANDARD_DEVIATION 3 • n=33 Participants	22 Kg/M^2 STANDARD_DEVIATION 3 • n=33 Participants	22 Kg/M^2 STANDARD_DEVIATION 3 • n=33 Participants	22 Kg/M^2 STANDARD_DEVIATION 3 • n=99 Participants
ASA I or II	33 Participants n=33 Participants	33 Participants n=33 Participants	33 Participants n=33 Participants	99 Participants n=99 Participants

PRIMARY outcome

Timeframe: 0 min after nasal intubation

the interval between opening the mouth and the time when three consecutive end-tidal CO2 waves were appeared on the monitor

Outcome measures

Measure	King Vision Video Laryngoscope n=33 Participants King Vision video laryngoscope: nasal intubation using King Vision video laryngoscope Device after general anesthesia induction	McGrath MAC Video Laryngoscope n=33 Participants McGrath MAC video laryngoscope: nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction	Macintosh n=28 Participants Macintosh laryngoscope: nasal intubation using Macintosh laryngoscope Device after general anesthesia induction
Time to Intubation	37.6 second Standard Deviation 7.3	35.4 second Standard Deviation 8.8	46.8 second Standard Deviation 10.4

SECONDARY outcome

Timeframe: after expose the glottis

time to expose the glottis

Outcome measures

Measure	King Vision Video Laryngoscope n=33 Participants King Vision video laryngoscope: nasal intubation using King Vision video laryngoscope Device after general anesthesia induction	McGrath MAC Video Laryngoscope n=33 Participants McGrath MAC video laryngoscope: nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction	Macintosh n=28 Participants Macintosh laryngoscope: nasal intubation using Macintosh laryngoscope Device after general anesthesia induction
Laryngoscopy Time	16.7 second Standard Deviation 5.5	15.6 second Standard Deviation 6.3	22.8 second Standard Deviation 7.2

SECONDARY outcome

Timeframe: 24h after surgery

sore throat, hoarseness, etc

Outcome measures

Measure	King Vision Video Laryngoscope n=33 Participants King Vision video laryngoscope: nasal intubation using King Vision video laryngoscope Device after general anesthesia induction	McGrath MAC Video Laryngoscope n=33 Participants McGrath MAC video laryngoscope: nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction	Macintosh n=28 Participants Macintosh laryngoscope: nasal intubation using Macintosh laryngoscope Device after general anesthesia induction
Number of Participants With Complications	6 Participants	7 Participants	21 Participants

Adverse Events

King Vision Video Laryngoscope

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

McGrath MAC Video Laryngoscope

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Macintosh

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	King Vision Video Laryngoscope n=33 participants at risk King Vision video laryngoscope: nasal intubation using King Vision video laryngoscope Device after general anesthesia induction	McGrath MAC Video Laryngoscope n=33 participants at risk McGrath MAC video laryngoscope: nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction	Macintosh n=33 participants at risk Macintosh laryngoscope: nasal intubation using Macintosh laryngoscope Device after general anesthesia induction
Respiratory, thoracic and mediastinal disorders bleeding	3.0% 1/33 • Number of events 1 • From the time of anesthesia induction to approximately 24 hours	0.00% 0/33 • From the time of anesthesia induction to approximately 24 hours	12.1% 4/33 • Number of events 4 • From the time of anesthesia induction to approximately 24 hours
Skin and subcutaneous tissue disorders dental injury	0.00% 0/33 • From the time of anesthesia induction to approximately 24 hours	0.00% 0/33 • From the time of anesthesia induction to approximately 24 hours	0.00% 0/33 • From the time of anesthesia induction to approximately 24 hours
Respiratory, thoracic and mediastinal disorders soar throat	9.1% 3/33 • Number of events 3 • From the time of anesthesia induction to approximately 24 hours	24.2% 8/33 • Number of events 8 • From the time of anesthesia induction to approximately 24 hours	36.4% 12/33 • Number of events 12 • From the time of anesthesia induction to approximately 24 hours
Respiratory, thoracic and mediastinal disorders Hoarseness	6.1% 2/33 • Number of events 2 • From the time of anesthesia induction to approximately 24 hours	3.0% 1/33 • Number of events 1 • From the time of anesthesia induction to approximately 24 hours	15.2% 5/33 • Number of events 5 • From the time of anesthesia induction to approximately 24 hours

Additional Information

Sun Yu

Shanghai ninth people's hospital

Phone: 13611895542

Email: dr_sunyu@163.com

Results disclosure agreements

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