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

Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404780
• Other study ID #: 11-0270-B
• Status: Completed
• Phase: N/A
• First received: June 21, 2011
• Last updated: February 20, 2013
• Start date: June 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Disease
• Lung Diseases

Intervention

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.
• Macintosh Direct Laryngoscope (MDL)
Current standard of care at UHN for 50 years

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	No
Secondary	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.	From the beginning of the operative procedure through to 24 hours postoperatively	Yes