Trial Outcomes & Findings for Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy Versus Direct Laryngoscopy (NCT NCT02405390)
NCT ID: NCT02405390
Last Updated: 2017-06-12
Results Overview
Head motion will only be measured while the patient is being endotracheally intubated. Usually this takes less than one minute. No follow up after that.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
During the process of intubation (less than one minute)
Results posted on
2017-06-12
Participant Flow
Participant milestones
| Measure |
Video Laryngoscopy
Some patients will be intubated with a video laryngoscope
Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system
Storz C-Mac® laryngoscope
|
Direct Laryngoscopy
Some patients will be intubated with a direct (conventional) laryngoscope
Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords
Storz C-Mac® laryngoscope
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
|
Overall Study
COMPLETED
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Head Motion in Pediatric Patients Endotracheally Intubated With Video Laryngoscopy Versus Direct Laryngoscopy
Baseline characteristics by cohort
| Measure |
Video Laryngoscopy
n=46 Participants
Some patients will be intubated with a video laryngoscope
Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system
Storz C-Mac® laryngoscope
|
Direct Laryngoscopy
n=46 Participants
Some patients will be intubated with a direct (conventional) laryngoscope
Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords
Storz C-Mac® laryngoscope
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.0 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
4.07 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
4.04 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Head Motion in degrees
Extension
|
17.7 participants
STANDARD_DEVIATION 11.1 • n=5 Participants
|
16.5 participants
STANDARD_DEVIATION 9.5 • n=7 Participants
|
17.05 participants
STANDARD_DEVIATION 10.18 • n=5 Participants
|
|
Head Motion in degrees
Flexion
|
9.6 participants
STANDARD_DEVIATION 8.0 • n=5 Participants
|
8.3 participants
STANDARD_DEVIATION 5.8 • n=7 Participants
|
8.95 participants
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Head Motion in degrees
Rotation Right
|
9.1 participants
STANDARD_DEVIATION 7.6 • n=5 Participants
|
7.9 participants
STANDARD_DEVIATION 6.6 • n=7 Participants
|
8.48 participants
STANDARD_DEVIATION 7.02 • n=5 Participants
|
|
Head Motion in degrees
Rotation Left
|
6.2 participants
STANDARD_DEVIATION 4.4 • n=5 Participants
|
6.5 participants
STANDARD_DEVIATION 7.0 • n=7 Participants
|
6.40 participants
STANDARD_DEVIATION 5.76 • n=5 Participants
|
PRIMARY outcome
Timeframe: During the process of intubation (less than one minute)Head motion will only be measured while the patient is being endotracheally intubated. Usually this takes less than one minute. No follow up after that.
Outcome measures
| Measure |
Video Laryngoscopy
n=45 Participants
Some patients will be intubated with a video laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
|
Direct Laryngoscopy
n=46 Participants
Some patients will be intubated with a direct (conventional) laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
|
|---|---|---|
|
Head Motion - Extension or Flexion
|
16.5 degrees of extension
Standard Deviation 9.5
|
17.7 degrees of extension
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: During the process of intubation (less than one minute)Time from when the laryngoscope blade enters the mouth until the endotracheal tube enters the vocal cords. No follow up after that.
Outcome measures
| Measure |
Video Laryngoscopy
n=45 Participants
Some patients will be intubated with a video laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
|
Direct Laryngoscopy
n=46 Participants
Some patients will be intubated with a direct (conventional) laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
|
|---|---|---|
|
Time for Intubation
|
25.8 second
Standard Deviation 18.4
|
18.9 second
Standard Deviation 10.8
|
Adverse Events
Video Laryngoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Direct Laryngoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jose M. Vargas Loayza, M.D.
Nicklaus Children's Hospital
Phone: 786-624-3588
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place