Comparison of Double Lumen Tube Placement Techniques

Not Applicable

Terminated

• Conditions: Tracheal Intubation Morbidity; Intubation Complication; Airway Morbidity; Anesthesia Intubation Complication; Failed or Difficult Intubation, Sequela
• Interventions: Device: Macintosh blade; Device: ZU-bend stylet; Device: GlideRite stylet; Device: GlideScope; Device: Regular Double-lumen endobronchial tube (DLT) Stylet

• Registration Number: NCT02495259
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-09
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-13
• Primary Completion: 2017-07-27
• Study Completion: 2017-07-27
• Results First Submitted: 2018-02-05
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-20
• Last Update Submitted: 2018-06-20
• Results First Posted: 2018-07-27
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macintosh blade and a regular DLT stylet	Macintosh blade	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.
GlideScope with the GlideRite stylet	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.
ZU-bend stylet with GlideScope technique	ZU-bend stylet	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.
ZU-bend stylet with GlideScope technique	GlideScope	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.
GlideScope with the GlideRite stylet	GlideScope	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.
Macintosh blade and a regular DLT stylet	Regular Double-lumen endobronchial tube (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.

Primary Outcome Measures

Name	Time	Method
Mean Time to Place the Double-lumen Endobronchial Tube	during laryngoscope placement, up to 120 seconds	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)

Secondary Outcome Measures

Name	Time	Method
Success Rate of First Endobronchial Intubation Attempt	during laryngoscope placement, up to 120 seconds	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 .
Number of Cases With Complications	during laryngoscope placement, up to 120 seconds	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).
Throat Pain	Up to 60 minutes after extubation	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.
Number of Cases of Voice Change	Up to 60 minutes after extubation	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.
Assessment of Difficulty of Intubation	during laryngoscope placement, up to 120 seconds	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).

Trial Locations

Locations (2)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States