Comparison of Double Lumen Tube Placement Techniques

Intubation Complication Clinical Trial

Official title:

Comparison of Placement of Double-lumen Endobronchial Tube Using GlideScope With 2 Different Stylet Configurations vs Standard Macintosh Laryngoscopy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02495259
• Other study ID #: IRB00081067
• Status: Terminated
• Phase: N/A
• Start date: July 2015
• Est. completion date: July 27, 2017

Study information

• Verified date: June 2018
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 27, 2017
• Est. primary completion date: July 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Success Rate of First Endobronchial Intubation Attempt	The rate of first intubation attempt success will be recorded by the anesthetist. A successful first attempt intubation is when the double-lumen endobronchial tube is placed during the initial laryngoscopy within 120 seconds. The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2). Higher numbers of successful first attempt intubations indicate better rates of success of first endobronchial intubation attempts .	during laryngoscope placement, up to 120 seconds
Secondary	Assessment of Difficulty of Intubation	The ease of successful placement of the double-lumen endobronchial tube (DLT) will be assessed by the anesthetist's responses to a multi-question form which includes the following items that are scored; overall ease of intubation, laryngoscope insertion, glottic view, double-lumen endobronchial tube (DLT) delivery and placement. The subjective scores range from 0-10; where 0=worst, 10=best. The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).	during laryngoscope placement, up to 120 seconds
Secondary	Number of Cases With Complications	Number of cases with complications during intubation will be will be assessed by the anesthetist's responses to a multi-question form which includes the following items; blood on device, SpO2 (peripheral capillary oxygen saturation) <96%, lip and dental trauma and double-lumen endobronchial tube (DLT) cuff rupture. The responses are recorded as Yes or No for each item. A 'yes' response indicates a complication. The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).	during laryngoscope placement, up to 120 seconds
Secondary	Number of Cases of Voice Change	Any voice change in the patient after extubation will be assessed in the Post-Operative Admission Unit (PACU) by asking the patient if any change in voice is experienced (Yes/No). The subjective answer given by the patient will be recorded. The average time for the patient to sufficiently recover to respond is expected to be 60 minutes after extubation.	Up to 60 minutes after extubation
Secondary	Throat Pain	Any voice change in the patient after extubation will be assessed in the Post-Operative Admission Unit (PACU) by recording the patient's response to the degree of pain experienced. An analog pain scale will be used for scoring where: 0= no pain and 10= severe pain. The average time for the patient to sufficiently recover to respond is expected to be 60 minutes after extubation.	Up to 60 minutes after extubation