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Comparison of Double Lumen Tube Placement Techniques

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Emory University

Status

Terminated

Conditions

Failed or Difficult Intubation, Sequela
Anesthesia Intubation Complication
Tracheal Intubation Morbidity
Intubation Complication
Airway Morbidity

Treatments

Device: GlideScope
Device: Macintosh blade
Device: GlideRite stylet
Device: Regular Double-lumen endobronchial tube (DLT) Stylet
Device: ZU-bend stylet

Study type

Interventional

Funder types

Other

Identifiers

NCT02495259
IRB00081067

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

19 participants in 3 patient groups

ZU-bend stylet with GlideScope technique
Experimental group
Description:
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the ZU-bend with the GlideScope technique of a double lumen endobronchial tube (DLT) placement as part of the anesthesia procedure prior to surgery.
Treatment:
Device: ZU-bend stylet
Device: GlideScope
GlideScope with the GlideRite stylet
Active Comparator group
Description:
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the GlideScope with the GlideRite stylet for placement of a double lumen endobronchial tube (DLT) as part of the anesthesia procedure prior to surgery.
Treatment:
Device: GlideRite stylet
Device: GlideScope
Macintosh blade and a regular DLT stylet
Active Comparator group
Description:
Subjects scheduled for thoracic surgery in which the surgeon requests lung isolation will undergo laryngoscopy and intubation using the direct laryngoscopy technique with the Macintosh blade and a regular double lumen endobronchial tube (DLT) stylet as part of the anesthesia procedure prior to surgery.
Treatment:
Device: Regular Double-lumen endobronchial tube (DLT) Stylet
Device: Macintosh blade

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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