Trial Outcomes & Findings for Endotrol-tracheal Tube Assisted Endotracheal Intubation During Video Laryngoscopy (NCT NCT01099969)
NCT ID: NCT01099969
Last Updated: 2018-06-04
Results Overview
Intubation time is the time from insertion of the laryngoscope to detection of CO2 on the capnogram.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
time from insertion of the laryngoscope to detection of CO2 on the capnogram
Results posted on
2018-06-04
Participant Flow
Participant milestones
| Measure |
GlideScope With Non-styletted Endotrol ETT
The patients in this arm will be intubated using a GlideScope videolaryngoscope with non-styletted Endotrol endotracheal tube (ETT).
GlideScope videolaryngoscope
Non-styletted Endotrol endotracheal tube (ETT)
|
GlideScope With Styletted Regular ETT
The patients in this arm will be intubated using the GlideScope videolaryngoscope with regular endotracheal tube (ETT) with GlideRite stylet.
GlideScope videolaryngoscope
Regular endotracheal tube (ETT) with GlideRite stylet
|
McGrath With Non-styletted Endotrol ETT
The patients in this arm will be intubated using McGrath videolaryngoscope and non-styletted Endotrol endotracheal tube (ETT).
McGrath videolaryngoscope
Non-styletted Endotrol endotracheal tube (ETT)
|
McGrath With With Styletted Regular ETT
The patients receiving this arm will be intubation using McGrath videolaryngoscope and regular endotracheal tube (ETT) with GlideRite stylet.
McGrath videolaryngoscope
Regular endotracheal tube (ETT) with GlideRite stylet
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endotrol-tracheal Tube Assisted Endotracheal Intubation During Video Laryngoscopy
Baseline characteristics by cohort
| Measure |
GlideScope With Non-styletted Endotrol ETT
n=15 Participants
The patients in this arm will be intubated using a GlideScope videolaryngoscope with non-styletted Endotrol endotracheal tube (ETT).
GlideScope videolaryngoscope
Non-styletted Endotrol endotracheal tube (ETT)
|
GlideScope With Styletted Regular ETT
n=15 Participants
The patients in this arm will be intubated using the GlideScope videolaryngoscope with regular endotracheal tube (ETT) with GlideRite stylet.
GlideScope videolaryngoscope
Regular endotracheal tube (ETT) with GlideRite stylet
|
McGrath With Non-styletted Endotrol ETT
n=15 Participants
The patients in this arm will be intubated using McGrath videolaryngoscope and non-styletted Endotrol endotracheal tube (ETT).
McGrath videolaryngoscope
Non-styletted Endotrol endotracheal tube (ETT)
|
McGrath With With Styletted Regular ETT
n=15 Participants
The patients receiving this arm will be intubation using McGrath videolaryngoscope and regular endotracheal tube (ETT) with GlideRite stylet.
McGrath videolaryngoscope
Regular endotracheal tube (ETT) with GlideRite stylet
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 13.1 • n=93 Participants
|
41.2 years
STANDARD_DEVIATION 14.4 • n=4 Participants
|
50.4 years
STANDARD_DEVIATION 14.1 • n=27 Participants
|
50.7 years
STANDARD_DEVIATION 15.7 • n=483 Participants
|
49.5 years
STANDARD_DEVIATION 15.1 • n=36 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
32 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
15 participants
n=4 Participants
|
15 participants
n=27 Participants
|
15 participants
n=483 Participants
|
60 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: time from insertion of the laryngoscope to detection of CO2 on the capnogramIntubation time is the time from insertion of the laryngoscope to detection of CO2 on the capnogram.
Outcome measures
| Measure |
GlideScope With Non-styletted Endotrol ETT
n=15 Participants
The patients in this arm will be intubated using a GlideScope videolaryngoscope with non-styletted Endotrol endotracheal tube (ETT).
GlideScope videolaryngoscope
Non-styletted Endotrol endotracheal tube (ETT)
|
GlideScope With Styletted Regular ETT
n=15 Participants
The patients in this arm will be intubated using the GlideScope videolaryngoscope with regular endotracheal tube (ETT) with GlideRite stylet.
GlideScope videolaryngoscope
Regular endotracheal tube (ETT) with GlideRite stylet
|
McGrath With Non-styletted Endotrol ETT
n=15 Participants
The patients in this arm will be intubated using McGrath videolaryngoscope and non-styletted Endotrol endotracheal tube (ETT).
McGrath videolaryngoscope
Non-styletted Endotrol endotracheal tube (ETT)
|
McGrath With With Styletted Regular ETT
n=15 Participants
The patients receiving this arm will be intubation using McGrath videolaryngoscope and regular endotracheal tube (ETT) with GlideRite stylet.
McGrath videolaryngoscope
Regular endotracheal tube (ETT) with GlideRite stylet
|
|---|---|---|---|---|
|
Intubation Time
|
60.2 seconds
Standard Deviation 34.8
|
48.8 seconds
Standard Deviation 30.8
|
58.6 seconds
Standard Deviation 29.9
|
40.7 seconds
Standard Deviation 24.4
|
PRIMARY outcome
Timeframe: at the time of placement of the endotracheal tubeOutcome measures
| Measure |
GlideScope With Non-styletted Endotrol ETT
n=15 Participants
The patients in this arm will be intubated using a GlideScope videolaryngoscope with non-styletted Endotrol endotracheal tube (ETT).
GlideScope videolaryngoscope
Non-styletted Endotrol endotracheal tube (ETT)
|
GlideScope With Styletted Regular ETT
n=15 Participants
The patients in this arm will be intubated using the GlideScope videolaryngoscope with regular endotracheal tube (ETT) with GlideRite stylet.
GlideScope videolaryngoscope
Regular endotracheal tube (ETT) with GlideRite stylet
|
McGrath With Non-styletted Endotrol ETT
n=15 Participants
The patients in this arm will be intubated using McGrath videolaryngoscope and non-styletted Endotrol endotracheal tube (ETT).
McGrath videolaryngoscope
Non-styletted Endotrol endotracheal tube (ETT)
|
McGrath With With Styletted Regular ETT
n=15 Participants
The patients receiving this arm will be intubation using McGrath videolaryngoscope and regular endotracheal tube (ETT) with GlideRite stylet.
McGrath videolaryngoscope
Regular endotracheal tube (ETT) with GlideRite stylet
|
|---|---|---|---|---|
|
Number of Intubation Attempts
3 attempts
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Intubation Attempts
1 attempt
|
13 Participants
|
14 Participants
|
14 Participants
|
13 Participants
|
|
Number of Intubation Attempts
2 attempts
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: at the time of placement of the endotracheal tubeEase of intubation was subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 2 = easy, 3 = neutral, 4 = difficult, 5 = extremely difficult). A score of 4 or 5 was characterized as "difficult."
Outcome measures
| Measure |
GlideScope With Non-styletted Endotrol ETT
n=15 Participants
The patients in this arm will be intubated using a GlideScope videolaryngoscope with non-styletted Endotrol endotracheal tube (ETT).
GlideScope videolaryngoscope
Non-styletted Endotrol endotracheal tube (ETT)
|
GlideScope With Styletted Regular ETT
n=15 Participants
The patients in this arm will be intubated using the GlideScope videolaryngoscope with regular endotracheal tube (ETT) with GlideRite stylet.
GlideScope videolaryngoscope
Regular endotracheal tube (ETT) with GlideRite stylet
|
McGrath With Non-styletted Endotrol ETT
n=15 Participants
The patients in this arm will be intubated using McGrath videolaryngoscope and non-styletted Endotrol endotracheal tube (ETT).
McGrath videolaryngoscope
Non-styletted Endotrol endotracheal tube (ETT)
|
McGrath With With Styletted Regular ETT
n=15 Participants
The patients receiving this arm will be intubation using McGrath videolaryngoscope and regular endotracheal tube (ETT) with GlideRite stylet.
McGrath videolaryngoscope
Regular endotracheal tube (ETT) with GlideRite stylet
|
|---|---|---|---|---|
|
Number of Difficult Intubations
|
1 intubations
|
0 intubations
|
2 intubations
|
0 intubations
|
SECONDARY outcome
Timeframe: at the time of intubationThe Comarck Lehane classification is as follows: 1)Full view of glottis; 2a) Partial view of glottis; 2b) Only posterior extremity of glottis seen or only arytenoid cartilages; 3) only epiglottis is seen, none of glottis seen; 4) neither glottis nor epiglottis seen.
Outcome measures
| Measure |
GlideScope With Non-styletted Endotrol ETT
n=15 Participants
The patients in this arm will be intubated using a GlideScope videolaryngoscope with non-styletted Endotrol endotracheal tube (ETT).
GlideScope videolaryngoscope
Non-styletted Endotrol endotracheal tube (ETT)
|
GlideScope With Styletted Regular ETT
n=15 Participants
The patients in this arm will be intubated using the GlideScope videolaryngoscope with regular endotracheal tube (ETT) with GlideRite stylet.
GlideScope videolaryngoscope
Regular endotracheal tube (ETT) with GlideRite stylet
|
McGrath With Non-styletted Endotrol ETT
n=15 Participants
The patients in this arm will be intubated using McGrath videolaryngoscope and non-styletted Endotrol endotracheal tube (ETT).
McGrath videolaryngoscope
Non-styletted Endotrol endotracheal tube (ETT)
|
McGrath With With Styletted Regular ETT
n=15 Participants
The patients receiving this arm will be intubation using McGrath videolaryngoscope and regular endotracheal tube (ETT) with GlideRite stylet.
McGrath videolaryngoscope
Regular endotracheal tube (ETT) with GlideRite stylet
|
|---|---|---|---|---|
|
Cormack and Lehane Grade of Laryngeal View
1
|
12 Participants
|
11 Participants
|
13 Participants
|
13 Participants
|
|
Cormack and Lehane Grade of Laryngeal View
2a
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Cormack and Lehane Grade of Laryngeal View
2b
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Cormack and Lehane Grade of Laryngeal View
3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cormack and Lehane Grade of Laryngeal View
4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
GlideScope With Non-styletted Endotrol ETT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GlideScope With Styletted Regular ETT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
McGrath With Non-styletted Endotrol ETT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
McGrath With With Styletted Regular ETT
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
Dr. Davide Cattano
The University of Texas Health Science Center at Houston
Phone: 713.500.6235
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place