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Trial record 39 of 3261 for:    Louisville

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 ]

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

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

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

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


  Serious Adverse Events


  Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

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.


Other Adverse Events
    Control   Intervention
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   0/70 (0.00%)   0/70 (0.00%) 



  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