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Endotrol-tracheal Tube Assisted Endotracheal Intubation During Video Laryngoscopy

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ClinicalTrials.gov Identifier: NCT01099969
Recruitment Status : Completed
First Posted : April 8, 2010
Results First Posted : June 4, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Davide Cattano, The University of Texas Health Science Center, Houston

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 Phase
Endotracheal Intubation Device: Glidescope videolaryngoscope Device: McGrath videolaryngoscope Device: Non-styletted Endotrol endotracheal tube (ETT) Device: Regular endotracheal tube (ETT) with Gliderite stylet Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: Glidescope with non-styletted Endotrol ETT
The patients in this arm will be intubated using a Glidescope videolaryngoscope with non-styletted Endotrol endotracheal tube (ETT).
Device: Glidescope videolaryngoscope
Device: Non-styletted Endotrol endotracheal tube (ETT)
Active Comparator: Glidescope with styletted regular ETT
The patientsin this arm will be intubated using the glidescope videolaryngoscope and regular endotracheal tube (ETT) with gliderite stylet.
Device: Glidescope videolaryngoscope
Device: Regular endotracheal tube (ETT) with Gliderite stylet
Experimental: McGrath with non-styletted Endotrol ETT
The patients in this arm will be intubated using McGrath videolaryngoscope and non-styletted Endotrol endotracheal tube (ETT).
Device: McGrath videolaryngoscope
Device: Non-styletted Endotrol endotracheal tube (ETT)
Active Comparator: McGrath with with styletted regular ETT
The patients receiving this arm will be intubation using McGrath videolaryngoscope and regular endotracheal tube (ETT) with Gliderite stylet.
Device: McGrath videolaryngoscope
Device: Regular endotracheal tube (ETT) with Gliderite stylet



Primary Outcome Measures :
  1. Intubation Time [ Time Frame: time from insertion of the laryngoscope to detection of CO2 on the capnogram ]
    Intubation time is the time from insertion of the laryngoscope to detection of CO2 on the capnogram.

  2. Number of Intubation Attempts [ Time Frame: at the time of placement of the endotracheal tube ]
  3. Number of Difficult Intubations [ Time Frame: at the time of placement of the endotracheal tube ]
    Ease of intubation was subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 2 = easy, 3 = neutral, 4 = difficult, 5 = extremely difficult). A score of 4 or 5 was characterized as "difficult."


Secondary Outcome Measures :
  1. Cormack and Lehane Grade of Laryngeal View [ Time Frame: at the time of intubation ]
    The Comarck Lehane classification is as follows: 1)Full view of glottis; 2a) Partial view of glottis; 2b) Only posterior extremity of glottis seen or only arytenoid cartilages; 3) only epiglottis is seen, none of glottis seen; 4) neither glottis nor epiglottis seen.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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

Responsible Party: Davide Cattano, Associate Professor - Anesthesiology, 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
Results First Posted: June 4, 2018
Last Update Posted: June 4, 2018
Last Verified: May 2018

Keywords provided by Davide Cattano, The University of Texas Health Science Center, Houston:
Endotrol Endotracheal tube
Regular endotracheal tube
gliderite stylet
McGrath videolaryngoscope
Glidescope