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Trial record 39 of 3257 for:    Louisville

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):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control

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

Intervention

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.


Participant Flow:   Overall Study
    Control   Intervention
STARTED   70   70 
COMPLETED   70   70 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control

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

Intervention

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 Total of all reporting groups

Baseline Measures
   Control   Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 70   70   140 
Age 
[Units: Years]
Mean (Standard Deviation)
 45  (13)   46  (14)   45  (13) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      37  52.9%      27  38.6%      64  45.7% 
Male      33  47.1%      43  61.4%      76  54.3% 
Region of Enrollment 
[Units: Participants]
     
United States   70   70   140 


  Outcome Measures

1.  Primary:   Intubation Time   [ Time Frame: 120 seconds ]

Measure Type Primary
Measure Title Intubation Time
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control

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

Intervention

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.


Measured Values
   Control   Intervention 
Participants Analyzed 
[Units: Participants]
 70   70 
Intubation Time 
[Units: Time in seconds]
Median (Inter-Quartile Range)
 66 
 (47 to 89) 
 71 
 (52 to 100) 


Statistical Analysis 1 for Intubation Time
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] <0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Secondary:   The Number of Intubation Attempts   [ Time Frame: 30 minutes ]

Measure Type Secondary
Measure Title The Number of Intubation Attempts
Measure Description counted as each approach of the ETT to the glottic entrance.
Time Frame 30 minutes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control

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

Intervention

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.


Measured Values
   Control   Intervention 
Participants Analyzed 
[Units: Participants]
 70   70 
The Number of Intubation Attempts 
[Units: Number of intubation attempts]
Mean (Standard Deviation)
 1.2  (0.6)   1.1  (0.4) 


Statistical Analysis 1 for The Number of Intubation Attempts
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] <0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



3.  Secondary:   Neck Movement   [ Time Frame: 30 minutes ]

Measure Type Secondary
Measure Title Neck Movement
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants with available data were analyzed for the assessment. All subjects reported had mild, moderate or severe neck movement.

Reporting Groups
  Description
Control

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

Intervention

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.


Measured Values
   Control   Intervention 
Participants Analyzed 
[Units: Participants]
 47   54 
Neck Movement 
[Units: Participants]
Count of Participants
 47   54 


Statistical Analysis 1 for Neck Movement
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Chi-squared
P Value [4] 0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



4.  Secondary:   Laryngeal View Grade of 1 or 2   [ Time Frame: 30 minutes ]

Measure Type Secondary
Measure Title Laryngeal View Grade of 1 or 2
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control

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

Intervention

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.


Measured Values
   Control   Intervention 
Participants Analyzed 
[Units: Participants]
 70   70 
Laryngeal View Grade of 1 or 2 
[Units: Participants]
Count of Participants
 62   50 


Statistical Analysis 1 for Laryngeal View Grade of 1 or 2
Groups [1] All groups
Statistical Test Type [2] Superiority
Statistical Method [3] Chi-squared
P Value [4] 0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



5.  Secondary:   Ease of Intubation   [ Time Frame: 2-4 hours after intubation ]

Measure Type Secondary
Measure Title Ease of Intubation
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control

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

Intervention

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.


Measured Values
   Control   Intervention 
Participants Analyzed 
[Units: Participants]
 70   70 
Ease of Intubation 
[Units: Units on a scale]
Mean (Standard Deviation)
 36  (23)   39  (25) 


Statistical Analysis 1 for Ease of Intubation
Groups [1] Control
Statistical Test Type [2] Superiority
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] 0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: rainer.lenhardt@louisville.edu


Publications of Results:

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