Clinical Comparison of the Airway Devices
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|ClinicalTrials.gov Identifier: NCT00581386|
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : March 4, 2010
Last Update Posted : September 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Endotracheal Intubation Supraglottic Airway||Device: LTS-D Device: ProSeal Laryngeal Mask Airway Device: Esophageal Tracheal Combitube (ETC)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||218 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Clinical Comparison Of The King Systems Disposable Laryngeal Tube Suction (LTS-D), The Esophageal Tracheal Combitube (ETC) And The Proseal Laryngeal Mask Airway (PLMA) In Adult Patients|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
All the cases were divided into one of the group LTS-D, PLMA, and ETC
supra-glottic airway device
Other Name: LTS-D King Systems, Noblesville, IN
Experimental: ProSeal Laryngeal Mask Airway
All patients were divided into either LTS-D, PLMA, or the ETC group.
Device: ProSeal Laryngeal Mask Airway
pre-existing double-lumen supra-glottic device
Other Name: Laryngeal Mask Airway (PLMA, LMA North America Inc.)
Experimental: Esophageal Tracheal Combitube (ETC)
All patients are divided into one of the group, LTS-D, PLMA, or the ETC.
Device: Esophageal Tracheal Combitube (ETC)
disposable double-lumen tube
Other Name: ETC
- Duration of Intubation [ Time Frame: duration of intubation ]The time taken to successfully place the device in seconds.
- Number of Participants With a Successful First Attempt Placement [ Time Frame: Time taken for successful placement ]The number of patients in whom the assigned device was successfully placed in the first attempt as per protocol.
- Number of Patients Who Required Multiple Attempts. [ Time Frame: Time taken for intubation ]The number of repeated attempts required for successfully placing the device. Each device was given a chance of 3 attempts if still unsuccessful after 3 attempts another device was placed.
- Leak Pressures [ Time Frame: Duration of surgery ]The maximum leak pressure attained for each device.
- Post Operative Morbidity [ Time Frame: 2 hrs and 24 hrs after surgery ]We followed the patients 2 and 24 hours after the surgery for sore throat, hoarseness and dysphagia.The numbers represented here are the number of patients who reported sore throat at 2 hrs and after 24 hrs as per the protocol.
- Number of Failed Cases [ Time Frame: Time taken for successful intubation ]We calculated the number of failed cases. As per protocol, that is number of patients in whom successful intubation was not achieved with the assigned device after 3 attempts.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581386
|United States, Texas|
|Memorial Hermann Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Carin A. Hagberg, M.D.||The University of Texas Medical School at Houston|