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Endotrol-tracheal Tube Assisted Endotracheal Intubation During Video Laryngoscopy

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ClinicalTrials.gov Identifier: NCT01099969
Recruitment Status : Unknown
Verified October 2010 by The University of Texas Health Science Center, Houston.
Recruitment status was:  Active, not recruiting
First Posted : April 8, 2010
Last Update Posted : October 15, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
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

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Endotrol-tracheal Tube Assisted Endotracheal Intubation During Video Laryngoscopy
Study Start Date : March 2010
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : March 2011
Arms and Interventions

Arm Intervention/treatment
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
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


Outcome Measures

Primary Outcome Measures :
  1. Time taken for intubation [ Time Frame: 6 months ]
    Time from start of placement to 1st capnographic breath


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

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
First Posted: April 8, 2010    Key Record Dates
Last Update Posted: October 15, 2010
Last Verified: October 2010

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