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Comparison of I-gel to the Laryngeal Mask Airway (I-gel)

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ClinicalTrials.gov Identifier: NCT00706823
Recruitment Status : Completed
First Posted : June 30, 2008
Results First Posted : April 5, 2011
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Carin A. Hagberg, The University of Texas Health Science Center, Houston

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: Endotracheal Intubation
Supraglottic Airway
Interventions: Device: i-gel airway (Intersurgical Ltd., Wokingham, England)
Device: Laryngeal Mask Airway-Unique

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The patients for this study have been recruited from Feb 2008 through July 2008. The patients were recruited from the day surgery and holding areas.

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
I-gel-SGA Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.
LMA-Unique Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the "model" in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation.

Participant Flow:   Overall Study
    I-gel-SGA   LMA-Unique
STARTED   25   25 
COMPLETED   25   25 
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
I-gel-SGA Patients who received i-gel SGA for intubation
LMA-Unique Patients who received LMA-Unique for intubation
Total Total of all reporting groups

Baseline Measures
   I-gel-SGA   LMA-Unique   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   50 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      1   4.0%      1   2.0% 
Between 18 and 65 years      25 100.0%      23  92.0%      48  96.0% 
>=65 years      0   0.0%      1   4.0%      1   2.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.2  (10.5)   35.3  (16.6)   37.28  (13.8) 
Gender 
[Units: Participants]
Count of Participants
     
Female      9  36.0%      6  24.0%      15  30.0% 
Male      16  64.0%      19  76.0%      35  70.0% 
Region of Enrollment 
[Units: Participants]
     
United States   25   25   50 


  Outcome Measures

1.  Primary:   Time Required for Intubation   [ Time Frame: duration of intubation ]

2.  Primary:   Leak Pressure   [ Time Frame: duration of intubation ]

3.  Secondary:   Level of Difficulty for Intubation   [ Time Frame: duration of intubation ]

4.  Secondary:   Number of Participants With Oropharyngeal Discomfort   [ Time Frame: post operative, immediately and 24 hrs after intubation ]

5.  Secondary:   Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization   [ Time Frame: after intubation ]

6.  Secondary:   Number of Attempts   [ Time Frame: Before intubation ]


  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:  
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: Carin A. Hagberg, MD
Organization: University of Texas Medical School at Houston
phone: 713-500-6222
e-mail: carin.a.hagberg@uth.tmc.edu



Responsible Party: Carin A. Hagberg, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00706823     History of Changes
Other Study ID Numbers: HSC-MS-08-0004
First Submitted: June 24, 2008
First Posted: June 30, 2008
Results First Submitted: March 8, 2011
Results First Posted: April 5, 2011
Last Update Posted: February 20, 2017