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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01404780
First received: June 21, 2011
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Lung Disease
Device: GlideScope (GVL)
Device: Macintosh Direct Laryngoscope (MDL)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparison of the Glidescope and Macintosh Laryngoscope for Double Lumen Endotracheal Tube Intubation

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Time to intubation (laryngoscope or DLT inserted between patient's lips to DLT placement in the trachea and laryngoscope withdrawal) [ 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: From the beginning of the operative procedure through to 24 hours postoperatively ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 70
Study Start Date: June 2011
Study Completion Date: February 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The GlideScope (GVL) Device: GlideScope (GVL)
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.
Active Comparator: Macintosh direct laryngoscope (MDL) Device: Macintosh Direct Laryngoscope (MDL)
Current standard of care at UHN for 50 years

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01404780

Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Adriaan Van Rensburg, MD University Health Network, Toronto General Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01404780     History of Changes
Other Study ID Numbers: 11-0270-B
Study First Received: June 21, 2011
Last Updated: February 20, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Double lumen ET intubation
Laryngoscope
Lung Surgery

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014