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Completed

NCT Number: NCT01404780

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

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.

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Key information

Conditions

Lung Disease Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Macintosh Direct Laryngoscope (MDL)

Device

Current standard of care at UHN for 50 years

Primary outcomes

  1. 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.

    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 outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jul 28, 2011
Registry last updated
Feb 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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