Comparison of Double Lumen Tube Placement Techniques

NCT ID: NCT02495259

Last Updated: 2018-07-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-07-27

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

ZU-bend stylet with GlideScope technique

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.

Group Type: EXPERIMENTAL

ZU-bend stylet

Intervention Type: 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 Zu-bend stylet is withdrawn as a part of placement procedure during the DLT advancement.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.

GlideScope

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

GlideScope

Intervention Type: 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.

GlideRite stylet

Intervention Type: 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.

Macintosh blade and a regular DLT stylet

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.

Group Type: ACTIVE_COMPARATOR

Macintosh blade

Intervention Type: 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.

Regular Double-lumen endobronchial tube (DLT) Stylet

Intervention Type: 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.

Interventions

ZU-bend stylet

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.

Intervention Type: DEVICE

GlideScope

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.

Intervention Type: DEVICE

GlideRite stylet

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.

Intervention Type: DEVICE

Macintosh blade

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.

Intervention Type: DEVICE

Regular Double-lumen endobronchial tube (DLT) Stylet

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.

Intervention Type: DEVICE

Other Intervention Names

Laryngoscope blade

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Igor Zhukov

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Igor Zhukov, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00081067

Identifier Type: -

Identifier Source: org_study_id