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Comparison of the Glidescope and Macintosh Laryngoscope for Double Lumen Endotracheal Tube Intubation

Primary Purpose

Lung Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
GlideScope (GVL)
Macintosh Direct Laryngoscope (MDL)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Disease focused on measuring Double lumen ET intubation, Laryngoscope, Lung Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Population: planned elective lung surgery requiring general anaesthesia with a double lumen endotracheal intubation, signed informed patient consent.

Exclusion Criteria:

  • Previous failed intubation,
  • history of difficult intubation or anticipated difficult intubation (2 risk factors of mallampati score 3 or greater,
  • incisor gap < 3.5cm, thyromental distance < 6.5cm,
  • reduced neck extension and flexion),
  • alternative method of intubation indicated eg rapid sequence intubation,
  • fibreoptic intubation,
  • contra-indication to a left double lumen tube eg endobronchial tumor,
  • significant deviation or compression of the trachea and bronchi.,
  • contraindication to one lung ventilation eg severe hypoxia or pulmonary hypertension,
  • anticipated difficult bag mask ventilation,
  • symptomatic gastro-oesophageal reflux,
  • oral/pharyngeal/laryngeal carcinoma,
  • loose teeth,
  • allergy to rocuronium, BMI > 40.

Sites / Locations

  • Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The GlideScope (GVL)

Macintosh direct laryngoscope (MDL)

Arm Description

Outcomes

Primary Outcome Measures

Time to intubation (laryngoscope or DLT inserted between patient's lips to DLT placement in the trachea and laryngoscope withdrawal)
Patients will be randomized to either MDL or GVL. If the first attempt fails to intubate within 2 minutes the anesthetist will remove the laryngoscope and provide mask ventilation. The second intubation attempt the anesthetist is encouraged to use the same randomized laryngoscope however, if the treating anesthetist feels a different device and technique will have a higher success rate they can perform that technique on the second attempt regardless of the randomized device. Anesthetists will complete a questionnaire after intubation.

Secondary Outcome Measures

Time to lung isolation, difficulty of the procedure, complication to the patients
Information about the procedure (times and complications) will be collected and documented by the study Anesthetist and questionnaires completed at the end of the 24hr postoperative period. Visits: patients will be followed up for a 24 hour period either on ward or by telephone if discharged, and assessed for sore throat, hoarseness, trauma to mouth and lips, dental damage and swallowing difficulties.

Full Information

First Posted
June 21, 2011
Last Updated
February 20, 2013
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01404780
Brief Title
Comparison of the Glidescope and Macintosh Laryngoscope for Double Lumen Endotracheal Tube Intubation
Official Title
Comparison of the Glidescope and Macintosh Laryngoscope for Double Lumen Endotracheal Tube Intubation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients undergoing chest surgery often require insertion of a breathing tube (double lumen tube) after they are unconscious. The double lumen tube enables the anaesthetist to ventilate (assist breathing) one lung at a time. The other lung is partially deflated to enable enough space for the surgeon to perform the procedure. The breathing tube is inserted with a laryngoscope (blade with a light at the end) so the vocal cords can be seen. This is standard medical practise. Two laryngoscopes are commonly used at Toronto General Hospital to insert the tube. The Macintosh laryngoscope has been is use for over 50 years and the Glidescope for over 10 years. Both devices have been extensively researched for single lumen tubes insertion and found to be very safe and effective. Research is limited to say which of the two laryngoscope is the most effective for double lumen tubes.
Detailed Description
The Glidescope (GVL) has been extensively studied for single lumen tube intubation and found to be a very safe and useful device. It is a particularly useful for patients with difficult airways as it has a camera attached to the blade. Despite being used for double lumen tube (DLT) intubations, research of its effectiveness and safety, is lacking. The study aims to determine the speed and safety of the GVL for DLT insertion. This information will assist anaesthetists in choosing the appropriate laryngoscope for DLT intubation of their patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease
Keywords
Double lumen ET intubation, Laryngoscope, Lung Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The GlideScope (GVL)
Arm Type
Experimental
Arm Title
Macintosh direct laryngoscope (MDL)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
GlideScope (GVL)
Intervention Description
The Glidescope (GVL) has not been extensively studied for double lumen tube intubation. The GVL may be particularly useful for patients with difficult airways as it has a camera attached to the blade.
Intervention Type
Device
Intervention Name(s)
Macintosh Direct Laryngoscope (MDL)
Intervention Description
Current standard of care at UHN for 50 years
Primary Outcome Measure Information:
Title
Time to intubation (laryngoscope or DLT inserted between patient's lips to DLT placement in the trachea and laryngoscope withdrawal)
Description
Patients will be randomized to either MDL or GVL. If the first attempt fails to intubate within 2 minutes the anesthetist will remove the laryngoscope and provide mask ventilation. The second intubation attempt the anesthetist is encouraged to use the same randomized laryngoscope however, if the treating anesthetist feels a different device and technique will have a higher success rate they can perform that technique on the second attempt regardless of the randomized device. Anesthetists will complete a questionnaire after intubation.
Time Frame
Number of minutes (0-2) that is required to intubate will be recorded, if a 2nd attempt is required, duration to successfull intubation will be recorded in minutes.
Secondary Outcome Measure Information:
Title
Time to lung isolation, difficulty of the procedure, complication to the patients
Description
Information about the procedure (times and complications) will be collected and documented by the study Anesthetist and questionnaires completed at the end of the 24hr postoperative period. Visits: patients will be followed up for a 24 hour period either on ward or by telephone if discharged, and assessed for sore throat, hoarseness, trauma to mouth and lips, dental damage and swallowing difficulties.
Time Frame
From the beginning of the operative procedure through to 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Population: planned elective lung surgery requiring general anaesthesia with a double lumen endotracheal intubation, signed informed patient consent. Exclusion Criteria: Previous failed intubation, history of difficult intubation or anticipated difficult intubation (2 risk factors of mallampati score 3 or greater, incisor gap < 3.5cm, thyromental distance < 6.5cm, reduced neck extension and flexion), alternative method of intubation indicated eg rapid sequence intubation, fibreoptic intubation, contra-indication to a left double lumen tube eg endobronchial tumor, significant deviation or compression of the trachea and bronchi., contraindication to one lung ventilation eg severe hypoxia or pulmonary hypertension, anticipated difficult bag mask ventilation, symptomatic gastro-oesophageal reflux, oral/pharyngeal/laryngeal carcinoma, loose teeth, allergy to rocuronium, BMI > 40.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriaan Van Rensburg, MD
Organizational Affiliation
University Health Network, Toronto General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Glidescope and Macintosh Laryngoscope for Double Lumen Endotracheal Tube Intubation

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