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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
History of Changes
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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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 ]
  Show Outcome Measure 1

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

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

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

Measure Type Primary
Measure Title Leak Pressures
Measure Description The maximum leak pressure attained for each device.
Time Frame Duration of surgery  
Safety Issue No  

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.

Measured Values
    Disposable Laryngeal Tube Suction (LTS-D)     Esophageal Tracheal Combitube(ETC)     ProSeal Laryngeal Mask Airway (PLMA)  
Number of Participants Analyzed  
[units: participants]
 		  73     73     72  
Leak Pressures  
[units: cm of H2O]
Mean ± Standard Deviation 		  25.9  ± 4.6     23.5  ± 5.3     24.4  ± 5.09  


Statistical Analysis 1 for Leak Pressures
Groups [1] Disposable Laryngeal Tube Suction (LTS-D) vs. Esophageal Tracheal Combitube(ETC)
Method [2] t-test, 2 sided
P Value [3] 0.006
Odds Ratio (OR) [4] 0.006
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] 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] Other relevant estimation information:
  No text entered.



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

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


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: Dr. Carin A. Hagberg
Organization: UTHSC- Houston Medical School
phone: 713.500.6222
e-mail: maddukuri.vineela@uth.tmc.edu


No publications provided


Responsible Party: Carin Hagberg, M.D./ Professor and Vice Chair, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00581386     History of Changes
Other Study ID Numbers: HSC-MS-04-254
Study First Received: December 20, 2007
Results First Received: July 28, 2009
Last Updated: March 3, 2010
Health Authority: United States: Institutional Review Board