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Clinical Comparison of the Airway Devices

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00581386
First Posted: December 27, 2007
Last Update Posted: September 20, 2016
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):
Carin A. Hagberg, The University of Texas Health Science Center, Houston
  Purpose
The purpose of this study is to evaluate a new supra-glottic airway device, the "Disposable Laryngeal Tube Suction" (LTS-D; King Systems, Noblesville, IN). We propose to test its ease of insertion, position within the airway, patency of drain tube and anatomic sealing properties during spontaneous ventilation in anesthetized patients. The study device will be compared to the ProSeal Laryngeal Mask Airway (PLMA, LMA North America Inc.) and the Esophageal Tracheal Combitube (ETC; Tyco Healthcare/Mallinckrodt Nellcor, Pleasanton, Calif).

Condition Intervention
Endotracheal Intubation Supraglottic Airway Device: LTS-D Device: ProSeal Laryngeal Mask Airway Device: Esophageal Tracheal Combitube (ETC)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Further study details as provided by Carin A. Hagberg, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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.


Enrollment: 218
Study Start Date: May 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LTS-D
All the cases were divided into one of the group LTS-D, PLMA, and ETC
Device: LTS-D
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subjects will be adult surgical candidates aged 18-80, ASA I-III, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary.
  2. Both male and female patients will be included.

Exclusion Criteria:

  • Patients will be excluded from the study if they present as Mallampati III or IV, ASA IV-V or emergency status. Additionally, they will be excluded if they meet one of the contraindication criteria of the LMA ProSeal including:

    1. Obesity
    2. Pregnancy
    3. History of gastric regurgitation, heart burn, ileus or "full stomach"
    4. History of low pulmonary compliance or high pulmonary resistance
    5. Known history of difficult endotracheal intubation or signs suggesting the possibility of difficult intubation
    6. Pharyngeal pathology or
    7. Upper airway obstruction due to laryngeal pathology.
  • Additionally, they will be excluded if they meet one of the contraindication criteria for the Combitube including:

    1. Intact gag reflexes
    2. Height <4 feet
    3. Central airway obstruction
    4. Recent ingestion of caustic substances
    5. Known esophageal pathology, or
    6. Known latex allergy.
  • They will also be excluded if any tracheal disease is present such as tracheal tumors, stenosis or previous tracheal surgery.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Carin A. Hagberg, M.D. The University of Texas Medical School at Houston
  More Information

Responsible Party: Carin A. Hagberg, Professor and Chairman, Joseph C. Gable, MD Endowed Chair, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00581386     History of Changes
Other Study ID Numbers: HSC-MS-04-254
First Submitted: December 20, 2007
First Posted: December 27, 2007
Results First Submitted: July 28, 2009
Results First Posted: March 4, 2010
Last Update Posted: September 20, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Carin A. Hagberg, The University of Texas Health Science Center, Houston:
Endotracheal Intubation
Supraglottic Airway


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