Airway Morbidity, Intubation Complication, Tracheal Intubation Morbidity, Anesthesia Intubation Complication, Failed or Difficult Intubation, Sequela
Conditions
Keywords
Double-lumen endobronchial tube, Laryngoscopy, intubating stylet
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.
Interventions
DEVICEZU-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 Zu-bend stylet is withdrawn as a part of placement procedure during the DLT advancement.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.
DEVICEGlideScope
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.
DEVICEGlideRite 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.
DEVICEMacintosh 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.
DEVICERegular 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.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 . |
| 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). |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 4 |
| 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. | 8 |
| Total | 19 |
Baseline characteristics
| Characteristic | ZU-bend Stylet With GlideScope Technique | GlideScope With the GlideRite Stylet | Macintosh Blade and a Regular DLT Stylet | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 4 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 2 Participants | 6 Participants | 14 Participants |
| Region of Enrollment United States | 7 Participants | 4 Participants | 8 Participants | 19 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 4 | 0 / 8 |
| other Total, other adverse events | 0 / 7 | 0 / 4 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 4 | 0 / 8 |
Outcome results
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)
Time frame: during laryngoscope placement, up to 120 seconds
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ZU-bend Stylet With GlideScope Technique | Mean Time to Place the Double-lumen Endobronchial Tube | 111 sec | Standard Deviation 44.9 |
| GlideScope With the GlideRite Stylet | Mean Time to Place the Double-lumen Endobronchial Tube | 54 sec | Standard Deviation 13.1 |
| Macintosh Blade and a Regular DLT Stylet | Mean Time to Place the Double-lumen Endobronchial Tube | 55 sec | Standard Deviation 17.5 |
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).
Time frame: during laryngoscope placement, up to 120 seconds
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ZU-bend Stylet With GlideScope Technique | Assessment of Difficulty of Intubation | 8 units on a scale | Standard Deviation 1.8 |
| GlideScope With the GlideRite Stylet | Assessment of Difficulty of Intubation | 10 units on a scale | Standard Deviation 0 |
| Macintosh Blade and a Regular DLT Stylet | Assessment of Difficulty of Intubation | 2 units on a scale | Standard Deviation 2.2 |
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.
Time frame: Up to 60 minutes after extubation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ZU-bend Stylet With GlideScope Technique | Number of Cases of Voice Change | 3 cases of voice change |
| GlideScope With the GlideRite Stylet | Number of Cases of Voice Change | 1 cases of voice change |
| Macintosh Blade and a Regular DLT Stylet | Number of Cases of Voice Change | 2 cases of voice change |
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).
Time frame: during laryngoscope placement, up to 120 seconds
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ZU-bend Stylet With GlideScope Technique | Number of Cases With Complications | 0 cases of complications |
| GlideScope With the GlideRite Stylet | Number of Cases With Complications | 0 cases of complications |
| Macintosh Blade and a Regular DLT Stylet | Number of Cases With Complications | 0 cases of complications |
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 .
Time frame: during laryngoscope placement, up to 120 seconds
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ZU-bend Stylet With GlideScope Technique | Success Rate of First Endobronchial Intubation Attempt | 4 Participants |
| GlideScope With the GlideRite Stylet | Success Rate of First Endobronchial Intubation Attempt | 3 Participants |
| Macintosh Blade and a Regular DLT Stylet | Success Rate of First Endobronchial Intubation Attempt | 8 Participants |
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.
Time frame: Up to 60 minutes after extubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ZU-bend Stylet With GlideScope Technique | Throat Pain | 1.4 units on a scale | Standard Deviation 1.6 |
| GlideScope With the GlideRite Stylet | Throat Pain | 1.3 units on a scale | Standard Deviation 1.5 |
| Macintosh Blade and a Regular DLT Stylet | Throat Pain | 1.9 units on a scale | Standard Deviation 2.2 |