Clinical Comparison of the Disposable Laryngeal Tube Suction, Esophageal Tracheal Combitube and Proseal Laryngeal Mask Airway

This study has been completed.
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00581386
First received: December 20, 2007
Last updated: March 3, 2010
Last verified: March 2010
Results First Received: July 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Intubation
Endotracheal
Interventions: Device: LTS-D
Device: ProSeal Laryngeal Mask Airway
Device: Esophageal Tracheal Combitube (ETC)

  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
Patients were recruited from the Memorial Hermann Hospital between 05/30/2007 and 04/15/2009. The patients enrolled were undergoing general anesthesia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no enrolled participants excluded from trial before assignment to groups.

Reporting Groups
  Description
Disposable Laryngeal Tube Suction (LTS-D) Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
Esophageal Tracheal Combitube(ETC) Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
ProSeal Laryngeal Mask Airway (PLMA) Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.

Participant Flow:   Overall Study
    Disposable Laryngeal Tube Suction (LTS-D)     Esophageal Tracheal Combitube(ETC)     ProSeal Laryngeal Mask Airway (PLMA)  
STARTED     73 [1]   73 [1]   72 [1]
COMPLETED     73 [2]   73 [2]   72 [2]
NOT COMPLETED     0     0     0  
[1] 05/30/2007
[2] 04/15/2009



  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
Disposable Laryngeal Tube Suction (LTS-D) Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
Esophageal Tracheal Combitube(ETC) Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
ProSeal Laryngeal Mask Airway (PLMA) Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
Total Total of all reporting groups

Baseline Measures
    Disposable Laryngeal Tube Suction (LTS-D)     Esophageal Tracheal Combitube(ETC)     ProSeal Laryngeal Mask Airway (PLMA)     Total  
Number of Participants  
[units: participants]
  73     73     72     218  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     73     73     72     218  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.84  ± 14.95     39.45  ± 13.73     40.08  ± 13.68     40.47  ± 14.12  
Gender  
[units: participants]
       
Female     23     23     17     63  
Male     50     50     55     155  
Region of Enrollment  
[units: participants]
       
United States     73     73     72     218  



  Outcome Measures
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1.  Primary:   Duration of Intubation   [ Time Frame: duration of intubation ]

2.  Primary:   Number of Participants With a Successful First Attempt Placement   [ Time Frame: Time taken for successful placement ]

3.  Primary:   Number of Patients Who Required Multiple Attempts.   [ Time Frame: Time taken for intubation ]

4.  Primary:   Leak Pressures   [ Time Frame: Duration of surgery ]

5.  Primary:   Post Operative Morbidity   [ Time Frame: 2 hrs and 24 hrs after surgery ]

6.  Primary:   Number of Failed Cases   [ Time Frame: Time taken for successful intubation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


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