Comparison of Double Lumen Tube Placement Techniques

NCT02495259 | Terminated Results

• 1 other identifier: IRB00081067
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Double-lumen endobronchial tube; Laryngoscopy; intubating stylet

Outcome Measures

Primary Outcomes (1)

• Mean Time to Place the Double-lumen Endobronchial Tube

  The time taken for successful intubation will be recorded by the anesthetist. The total duration from the time the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2), an average of 120 seconds, will be recorded in seconds. A higher duration noted is indicative of a longer time taken for successful intubation. 0 seconds (laryngoscope at patient's lips), (first End-tidal CO2 (EtCO2) detection)

  during laryngoscope placement, up to 120 seconds

Secondary Outcomes (5)

• Success Rate of First Endobronchial Intubation Attempt

  during laryngoscope placement, up to 120 seconds

• Assessment of Difficulty of Intubation

  during laryngoscope placement, up to 120 seconds

• Number of Cases With Complications

  during laryngoscope placement, up to 120 seconds

• Number of Cases of Voice Change

  Up to 60 minutes after extubation

• Throat Pain

  Up to 60 minutes after extubation

Study Arms (3)

ZU-bend stylet with GlideScope technique

EXPERIMENTAL

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.

Device: ZU-bend stylet; Device: GlideScope

GlideScope with the GlideRite stylet

ACTIVE COMPARATOR

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.

Device: GlideScope; Device: GlideRite stylet

Macintosh blade and a regular DLT stylet

ACTIVE COMPARATOR

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.

Device: Macintosh blade; Device: Regular Double-lumen endobronchial tube (DLT) Stylet

Interventions

ZU-bend stylet DEVICE

Laryngoscopy and intubation after induction of anesthesia will be done using the GlideScope and the ZU-bend stylet. The ZU-bend is a specific shaping technique of the intubating stylet that is closely related to the GlideScope blade curvature. Zu-bend stylet is withdrawn as a part of placement procedure during the DLT advancement. Thereafter, GlideScope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.

ZU-bend stylet with GlideScope technique

GlideScope DEVICE

Laryngoscopy and intubation after induction of anesthesia will be done using the the GlideScope technique. The GlideScope is a video laryngoscope that provides a real-time view of the airway and tube placement during intubation. GlideScope is removed after DLT is in the trachea, and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.

GlideScope with the GlideRite stylet; ZU-bend stylet with GlideScope technique

GlideRite stylet DEVICE

Laryngoscopy and intubation after induction of anesthesia will be done with the GlideScope using the GlideRite stylet. The GlideRite stylet is specifically designed to work with the GlideScope and provides the necessary rigidity and curvature to an otherwise flexible tube. GlideRite stylet is withdrawn as a part of placement procedure during the DLT advancement. Thereafter, GlideScope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.

GlideScope with the GlideRite stylet

Macintosh blade DEVICE

Direct laryngoscopy and intubation after induction of anesthesia will be done with the Macintosh blade and a regular double-lumen endobronchial tube (DLT) stylet. The Macintosh blade is used to facilitate visualization of the larynx during double or single lumen endobronchial tube placement. After intubation the Macintosh laryngoscope is removed and the confirmation of the successful placement of the double-lumen endobronchial tube in done in the standard fashion.

Also known as: Laryngoscope blade

Macintosh blade and a regular DLT stylet

Regular Double-lumen endobronchial tube (DLT) Stylet DEVICE

Direct laryngoscopy and intubation after induction of anesthesia will be done with a regular double-lumen endobronchial tube (DLT) stylet and the Macintosh blade. The DLT stylet is withdrawn as a part of placement procedure during the DLT advancement. Thereafter, Macintosh laryngoscope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.

Macintosh blade and a regular DLT stylet

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Results Point of Contact

• Title: Dr. Igor Zhukov
• Organization: Emory University

izhukov@live.com

404-268-1404

Study Officials

• Igor Zhukov, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 13, 2015
• Study Start: July 1, 2015
• Primary Completion: July 27, 2017
• Study Completion: July 27, 2017
• Last Updated: July 27, 2018
• Results First Posted: July 27, 2018

Record last verified: 2018-06

Locations

US (2)