Clinical Comparison of the Airway Devices

NCT00581386 | Completed Results

• 1 other identifier: HSC-MS-04-254
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Endotracheal Intubation; Supraglottic Airway

Keywords

Endotracheal Intubation; Supraglottic Airway

Outcome Measures

Primary Outcomes (6)

• Duration of Intubation

  The time taken to successfully place the device in seconds.

  duration of intubation

• Number of Participants With a Successful First Attempt Placement

  The number of patients in whom the assigned device was successfully placed in the first attempt as per protocol.

  Time taken for successful placement

• Number of Patients Who Required Multiple Attempts.

  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.

  Time taken for intubation

• Leak Pressures

  The maximum leak pressure attained for each device.

  Duration of surgery

• Post Operative Morbidity

  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.

  2 hrs and 24 hrs after surgery

• Number of Failed Cases

  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.

  Time taken for successful intubation

Study Arms (3)

LTS-D

EXPERIMENTAL

All the cases were divided into one of the group LTS-D, PLMA, and ETC

Device: LTS-D

ProSeal Laryngeal Mask Airway

EXPERIMENTAL

All patients were divided into either LTS-D, PLMA, or the ETC group.

Device: ProSeal Laryngeal Mask Airway

Esophageal Tracheal Combitube (ETC)

EXPERIMENTAL

All patients are divided into one of the group, LTS-D, PLMA, or the ETC.

Device: Esophageal Tracheal Combitube (ETC)

Interventions

LTS-D DEVICE

supra-glottic airway device

Also known as: LTS-D King Systems, Noblesville, IN

LTS-D

ProSeal Laryngeal Mask Airway DEVICE

pre-existing double-lumen supra-glottic device

Also known as: Laryngeal Mask Airway (PLMA, LMA North America Inc.)

ProSeal Laryngeal Mask Airway

Esophageal Tracheal Combitube (ETC) DEVICE

disposable double-lumen tube

Also known as: ETC

Esophageal Tracheal Combitube (ETC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Obesity
• Pregnancy
• History of gastric regurgitation, heart burn, ileus or "full stomach"
• History of low pulmonary compliance or high pulmonary resistance
• Known history of difficult endotracheal intubation or signs suggesting the possibility of difficult intubation
• Pharyngeal pathology or
• Upper airway obstruction due to laryngeal pathology.
• Additionally, they will be excluded if they meet one of the contraindication criteria for the Combitube including:
• Intact gag reflexes
• Height \<4 feet
• Central airway obstruction
• Recent ingestion of caustic substances
• Known esophageal pathology, or
• Known latex allergy.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Carin A. Hagberg
• Organization: UTHSC- Houston Medical School

maddukuri.vineela@uth.tmc.edu

713.500.6222

Study Officials

• Carin A. Hagberg, M.D.

  The University of Texas Medical School at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Joseph C. Gable, MD Endowed Chair

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 27, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 20, 2016
• Results First Posted: March 4, 2010

Record last verified: 2016-08

Locations

US (1)