Clinical Comparison of the LTS-D, ETC and Proseal Laryngeal Mask Airway - Full Text View

Sponsored by:	The University of Texas Health Science Center, Houston
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00581386

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
Intubation Endotracheal	Device: Laryngeal Tube Suction Disposable (LTS-D) Device: ProSeal Laryngeal Mask Airway Device: Esophageal Tracheal Combitube

MedlinePlus related topics: Esophagus Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
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 The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

Time and number of attempts required; [ Time Frame: duration of intubation ] [ Designated as safety issue: No ]
Level of difficulty for intubation [ Time Frame: duration of intubation ] [ Designated as safety issue: No ]
Degree of irritation of the pharynx, epiglottis, and arytenoids [ Time Frame: post operative, immediately and 24 hours later ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

vital signs, oxygen saturation, end-tidal carbon dioxide [ Time Frame: duration of intubation ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	225
Study Start Date:	August 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

supra-glottic airway device

pre-existing double-lumen supra-glottic device

disposable double-lumen tube

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581386

Contacts

Contact: Carin A. Hagberg, M.D.	713.500.6195	carin.a.hagberg@uth.tmc.edu
Contact: Dawn G Iannucci, M.S. II	713.500.6195	dawn.iannucci@uth.tmc.edu

Locations

United States, Texas
Memorial Hermann Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Carin A Hagberg, M.D. 713-500-6240 carin.a.hagberg@uth.tmc.edu
Principal Investigator: Carin A Hagberg, MD
Sub-Investigator: Nicholas C Lam, MD

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:	The University of Texas Health Science Center, Houston ( Carin Hagberg, M.D./ Professor and Vice Chair )
Study ID Numbers:	HSC-MS-04-254
Study First Received:	December 20, 2007
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00581386
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:

Endotracheal Intubation
Supraglottic Airway

Study placed in the following topic categories:

Esophageal disorder
Esophageal Diseases

ClinicalTrials.gov processed this record on January 13, 2009