Endotrol-tracheal Tube Assisted Endotracheal Intubation During Video Laryngoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by The University of Texas Health Science Center, Houston.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01099969
First received: April 1, 2010
Last updated: October 14, 2010
Last verified: October 2010
  Purpose

The purpose of this study is to compare the safety and efficacy of Endotrol Tube compared to the conventional endotracheal tube in conjunction with the GlideRite stylet (Verathon Medical Inc, USA) during videolaryngoscopy assisted endotracheal intubation using a McGrath (Aircraft Medical Ltd., and distributed in the US by LMA North America, Inc.) video laryngoscope or a GlideScope (Verathon Medical Inc, USA). The investigators hypothesize that using the Endotrol tracheal tube, (Covidien, Colorado, USA) is safer and more efficacious than using the conventional endotracheal tube during McGrath video laryngoscope and/or GlideScope aided endotracheal intubation.


Condition Intervention
Endotracheal Intubation
Device: Glidescope with Endotrol endotracheal tube
Device: Glidescope with styletted regular endotracheal tube
Device: McGrath with Endotrol
Device: McGrath with Styletted regular Endotracheal tube

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Endotrol-tracheal Tube Assisted Endotracheal Intubation During Video Laryngoscopy

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

Primary Outcome Measures:
  • Time taken for intubation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Time from start of placement to 1st capnographic breath


Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glidescope with Endotrol Device: Glidescope with Endotrol endotracheal tube
The patients receiving this intervention will be intubated using a Glidescope video laryngoscope with non-styletted Endotrol endotracheal tune
Other Name: Glidescope with Endotrol
Placebo Comparator: Glidescope with regular ETT Device: Glidescope with styletted regular endotracheal tube
The patients receiving this intervention will be intubated using the glidescope videolaryngoscope and regular endotracheal tube with gliderite stylet.
Other Name: Glidescope with regular ETT
Experimental: McGrath with Endotrol Device: McGrath with Endotrol
The patients in this intervention will be intubated using McGrath videolaryngoscope and non-stlyetted Endotrol endotracheal tube
Other Name: McGrath with Endotrol
Placebo Comparator: McGrath with regular ETT Device: McGrath with Styletted regular Endotracheal tube
The patients receiving this intervention will be intubation using McGrath videolaryngoscope and regular endotracheal tube with gliderite stylet.
Other Name: McGrath with regular ETT

  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:

  • Age: 18-80 years old
  • ASA: I-III
  • Mallampati: I-III
  • Mouthopening: 2 FB or < 4 cm

Exclusion Criteria:

  • Age < 18 years or > 80 years
  • ASA: IV
  • Mallampati: IV
  • Mouthopening < 2 FB 4cm
  • No risk for aspiration
  • No respiratory infection in past 10 days
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099969

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: Davide Cattano, M.D.,PhD The University of Texas Medical School at Houston
  More Information

No publications provided

Responsible Party: Davide Cattano, M.D., PhD/ Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01099969     History of Changes
Other Study ID Numbers: HSC-MS-09-0456
Study First Received: April 1, 2010
Last Updated: October 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Endotrol Endotracheal tube
Regular endotracheal tube
glide rite stylet
McGarth video laryngoscope
Glidescope
comparison of endotrol endotracheal tube to regular endotracheal tube with video laryngoscopes Glidescope and McGrath

ClinicalTrials.gov processed this record on July 20, 2014