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Airway Scope and Macintosh Laryngoscope for Tracheal Intubation in Patients Lying on the Ground

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00980590
First Posted: September 21, 2009
Last Update Posted: February 6, 2017
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.
Information provided by (Responsible Party):
The Cleveland Clinic
Results First Submitted: December 12, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Condition: Intubation
Interventions: Device: Airway Scope
Device: Macintosh Laryngoscope

  Participant Flow
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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
Airway Scope

Intubation with Airway Scope

Airway Scope: Tracheal intubation by Airway Scope

Macintosh Laryngoscope

Intubation with Macintosh laryngoscope

Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope


Participant Flow:   Overall Study
    Airway Scope   Macintosh Laryngoscope
STARTED   50   50 
COMPLETED   50   50 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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
Airway Scope

Intubation with Airway Scope

Airway Scope: Tracheal intubation by Airway Scope

Macintosh Laryngoscope

Intubation with Macintosh laryngoscope

Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope

Total Total of all reporting groups

Baseline Measures
   Airway Scope   Macintosh Laryngoscope   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   50   100 
Age 
[Units: Years]
Mean (Standard Deviation)
 60  (19)   53  (18)   55  (20) 
Gender 
[Units: Participants]
Count of Participants
     
Female      30  60.0%      22  44.0%      52  52.0% 
Male      20  40.0%      28  56.0%      48  48.0% 
Mouth opening 
[Units: Cm]
Mean (Standard Deviation)
 4.6  (0.7)   4.7  (0.7)   4.7  (0.7) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 158  (9)   162  (9)   160  (10) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 56  (10)   58  (10)   57  (10) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Intubation Time   [ Time Frame: The time from picking up the Airway Scope or Macintosh laryngoscope to confirmation of tracheal intubation by capnography. ]

2.  Secondary:   Overall Intubation Success Rate   [ Time Frame: Intubation period ]

3.  Secondary:   Number of Intubation Attempts   [ Time Frame: Intubation period ]

4.  Secondary:   Incidence of Intubation Complications   [ Time Frame: Intubation period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Patients with anticipated airway difficulties were excluded. All intubations were performed by a single investigator.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Daniel Sessler
Organization: Cleveland Clinic
phone: 216-445-6500
e-mail: sessled@ccf.org



Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00980590     History of Changes
Other Study ID Numbers: 44-012
First Submitted: September 18, 2009
First Posted: September 21, 2009
Results First Submitted: December 12, 2016
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017