Clinical trial NCT02495259: Comparison of Double Lumen Tube Placement Techniques
Official title: Comparison of Placement of Double-lumen Endobronchial Tube Using GlideScope With 2 Different Stylet Configurations vs Standard Macintosh Laryngoscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Airway Morbidity
Intubation Complication
Tracheal Intubation Morbidity
Anesthesia Intubation Complication
Failed or Difficult Intubation, Sequela
Keywords: Double-lumen endobronchial tube
Laryngoscopy
intubating stylet
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare three different standard of care methods of double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have thoracic surgery in which lung isolation is required.

Detailed description: The purpose of this study is to compare three different standard of care methods of double-lumen endobronchial tube (DLT) placement in patients who are scheduled to have thoracic surgery in which lung isolation is required. The investigators want to evaluate the technique of placement of the double-lumen endobronchial tube (DLT) using an included stylet that has been radically bent (ZU-bend) as compared to a commercial GlideRite stylet with the GlideScope and direct laryngoscopy using the Macintosh laryngoscope. A double-lumen endobronchial tube (DLT) is a breathing tube utilized to manage the airway when lung separation is needed for a surgical procedure. The investigator wants to evaluate how long it takes for successful placement of the double-lumen endobronchial tube (DLT) and assess the difficulty of the procedure experienced by the physician performing the intubation.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients requiring a double-lumen endobronchial tube placement for surgery at Emory University Hospital or Emory University Hospital Midtown
2. Patients willing and able to provide written informed consent

Exclusion Criteria:

1. Patients in whom a previously difficult airway manipulation was recorded on an anesthetic record
2. Lung transplantation procedures, as underlying pulmonary disorder that will confound the SpO2 (peripheral capillary oxygen saturation) metric
3. Any patient who is receiving anticoagulants in excess of a daily aspirin, patients with an International Normalized Ratio or INR \>1
4. Patients in whom one lung ventilation or placement of a double-lumen endobronchial tube is contraindicated
5. Patients who require a rapid-sequence intubation
6. Patients undergoing emergency procedures

Primary outcomes:
measure: Mean Time to Place the Double-lumen Endobronchial Tube
timeFrame: during laryngoscope placement, up to 120 seconds
Secondary outcomes:
measure: Success Rate of First Endobronchial Intubation Attempt
timeFrame: during laryngoscope placement, up to 120 seconds
measure: Assessment of Difficulty of Intubation
timeFrame: during laryngoscope placement, up to 120 seconds
measure: Number of Cases With Complications
timeFrame: during laryngoscope placement, up to 120 seconds
measure: Number of Cases of Voice Change
timeFrame: Up to 60 minutes after extubation
measure: Throat Pain
timeFrame: Up to 60 minutes after extubation
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Igor Zhukov, MD
role: PRINCIPAL_INVESTIGATOR
References: