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Video-laryngoscope With a Novel Video-stylet for Difficult Intubation

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ClinicalTrials.gov Identifier: NCT01215695
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : July 27, 2017
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Rainer Lenhardt, University of Louisville

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Condition Difficult Endotracheal Intubation
Interventions Device: aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)
Device: Control
Enrollment 140
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Intervention
Hide Arm/Group Description

Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)

Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope

Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).

aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.

Period Title: Overall Study
Started 70 70
Completed 70 70
Not Completed 0 0
Arm/Group Title Control Intervention Total
Hide Arm/Group Description

Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)

Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope

Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).

aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.

Total of all reporting groups
Overall Number of Baseline Participants 70 70 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 70 participants 140 participants
45  (13) 46  (14) 45  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 participants
Female
37
  52.9%
27
  38.6%
64
  45.7%
Male
33
  47.1%
43
  61.4%
76
  54.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 70 participants 70 participants 140 participants
70 70 140
1.Primary Outcome
Title Intubation Time
Hide Description divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above). Interim bag and mask time, if needed, will not be included in the intubation time. More than 5 attempts or 120 s are regarded as failure of intubation. If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.
Time Frame 120 seconds
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:

Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)

Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope

Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).

aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.

Overall Number of Participants Analyzed 70 70
Median (Inter-Quartile Range)
Unit of Measure: time in seconds
66
(47 to 89)
71
(52 to 100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title The Number of Intubation Attempts
Hide Description counted as each approach of the ETT to the glottic entrance.
Time Frame 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:

Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)

Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope

Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).

aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.

Overall Number of Participants Analyzed 70 70
Mean (Standard Deviation)
Unit of Measure: Number of intubation attempts
1.2  (0.6) 1.1  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Neck Movement
Hide Description One observer will video-record the entire intubation procedure. At a later time, an otherwise unrelated observer will watch the video-records and grade the neck movement during intubation. Neck movement will be classified as Grade 0: no neck movement, Grade 1: minimal neck movement, or Grade 2: moderate neck movement. Results are reported as total with mild, moderate, or severe neck movement.
Time Frame 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants with available data were analyzed for the assessment. All subjects reported had mild, moderate or severe neck movement.
Arm/Group Title Control Intervention
Hide Arm/Group Description:

Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)

Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope

Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).

aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.

Overall Number of Participants Analyzed 47 54
Measure Type: Count of Participants
Unit of Measure: Participants
47
 100.0%
54
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Laryngeal View Grade of 1 or 2
Hide Description The laryngeal view as Grade 1 (full view of the glottis) or Grade 2 (glottis partly exposed, anterior commissure not seen) according to the method described by Cormack and Lehane (1984).
Time Frame 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:

Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)

Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope

Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).

aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.

Overall Number of Participants Analyzed 70 70
Measure Type: Count of Participants
Unit of Measure: Participants
62
  88.6%
50
  71.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Ease of Intubation
Hide Description After completion of the procedure the intubator will be asked to score the ease of intubation. To do this, he/she will give a score from 0-100 with 0 being the easiest and 100 being the hardest.
Time Frame 2-4 hours after intubation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:

Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)

Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope

Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).

aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.

Overall Number of Participants Analyzed 70 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
36  (23) 39  (25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Intervention
Hide Arm/Group Description

Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)

Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope

Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).

aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.

All-Cause Mortality
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)      0/70 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Control Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/70 (2.86%)      2/70 (2.86%)    
Respiratory, thoracic and mediastinal disorders     
Unable to intubate * [1]  2/70 (2.86%)  2 2/70 (2.86%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Four patients could not be intubated with VLS and rigid stylet. These patients were subsequently intubated successfully using the alternative method with a complementary flexible tracheoscope
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/70 (0.00%)      0/70 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Rainer Lenhardt, MD
Organization: University Louisville
Phone: 502-228-7517
Responsible Party: Rainer Lenhardt, University of Louisville
ClinicalTrials.gov Identifier: NCT01215695     History of Changes
Other Study ID Numbers: UofL IRB #10.0300
First Submitted: July 22, 2010
First Posted: October 6, 2010
Results First Submitted: April 9, 2017
Results First Posted: July 27, 2017
Last Update Posted: September 8, 2017