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

NCT01404780 | Completed

• 1 other identifier: 11-0270-B
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Disease

Keywords

Double lumen ET intubation; Laryngoscope; Lung Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Time to lung isolation, difficulty of the procedure, complication to the patients

  From the beginning of the operative procedure through to 24 hours postoperatively

Study Arms (2)

The GlideScope (GVL)

EXPERIMENTAL

Device: GlideScope (GVL)

Macintosh direct laryngoscope (MDL)

ACTIVE COMPARATOR

Device: Macintosh Direct Laryngoscope (MDL)

Interventions

GlideScope (GVL) DEVICE

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.

The GlideScope (GVL)

Macintosh Direct Laryngoscope (MDL) DEVICE

Current standard of care at UHN for 50 years

Macintosh direct laryngoscope (MDL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Adriaan Van Rensburg, MD

  University Health Network, Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: July 28, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: February 1, 2013
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

CA (1)