Video-Laryngoscope Alone or With Bronchoscope for Predicted Difficult Intubation
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/29/2017 |
| Start Date: | April 10, 2017 |
| End Date: | December 2019 |
| Contact: | Rainer Lenhardt, MD, MBA |
| Email: | rainer.lenhardt@louisville.edu |
| Phone: | 502852-3122 |
Comparison of Video-Laryngoscope Versus a Combination of a Video-Laryngoscope and Disposable Bronchoscope for Predicted Difficult Airway Intubation of Anesthetized Patients for Oral Cavity, Pharynx or Larynx Surgery
Using a combination of the video-laryngoscope with the disposable fiber-optic bronchoscope
(aScope III) is a feasible way to facilitate successful intubation in a timely manner, in
patients with predicted difficult airway due to tumors in the oral cavity, pharynx or larynx
To test the hypothesis that combination of video-laryngoscope with the fiber-optic
bronchoscope is superior to video-laryngoscope alone for intubation of patients with oral
cavity, pharyngeal or laryngeal pathologies undergoing surgery
(aScope III) is a feasible way to facilitate successful intubation in a timely manner, in
patients with predicted difficult airway due to tumors in the oral cavity, pharynx or larynx
To test the hypothesis that combination of video-laryngoscope with the fiber-optic
bronchoscope is superior to video-laryngoscope alone for intubation of patients with oral
cavity, pharyngeal or laryngeal pathologies undergoing surgery
Detailed Description:
All subjects consented to this study will require endotracheal intubation. They will be
randomly assigned to either one of two groups. The randomization will be stratified on
whether the subject has an oral cavity/pharynx tumor or laryngeal tumor. The randomization
groups are:
1. Intubation using King Vision video-laryngoscope with the disposable #3 blade and a
stylet for placement of the endotracheal tube. This group is considered the "control
group".
2. Intubation using the King Vision video-laryngoscope with the disposable #3 blade and
the fiber-optic bronchoscope (aScope III). This group is considered the "interventional
group".
When randomized to the "control group" (King Vision video-laryngoscope with #3 disposable
blade and a stylet) the procedure sequence is as follows:
1. Standard anesthesia monitoring which includes but is not limited to ECG, pulse
oximetry, capnography, blood pressure and temperature monitoring. Their head will be on
an anesthesia pillow. This is all standard procedure.
2. Anesthesiologist will induced with Fentanyl (1-2 ug/kg), propofol (2-4 mg/kg). This is
standard dosing.
3. Subjects will receive muscle relaxation using Rocuronium (0.6mg/kg) This is standard
dosing.
4. The patient will be pre-oxygenated for 2-3 minutes with 100% oxygen by mask to achieve
optimal oxygen saturation
5. One anesthesiologist will perform the intubation procedure using the King Vision
video-laryngoscope with a #3 disposable blade and use a stylet to pre-form the
endotracheal tube (ETT).
6. If the anesthesiologist's first attempt to intubate should fail the next attempt will
use the standard Storz video-laryngoscope and a #4 reusable blade, a stylet to pre-form
the endotracheal tube (ETT) and with external laryngeal pressure. (BURP: back, up, and
rightward pressure)
7. The anesthesiologist may make a total of three attempts to intubate using the control
group procedures. Each attempt should be less than 60 seconds and will be aborted if
oxygen saturation falls below 90%. The patient will be pre-oxygenated by mask between
each attempt.
8. After three failed attempts to intubate the anesthesiologist will use the
interventional group method. Two anesthesiologists will be required to perform the
intubation using the King Vision video-laryngoscope with a #3 disposable blade and the
video bronchoscope (aScope III). The stylet will not be needed since the bronchoscope
will be used to guide the endotracheal tube (ETT).
9. The video-laryngoscope will be used to visualize the glottis; the bronchoscope (aScope
III) will be inserted underneath the epiglottis and advance to the carina under direct
visualization. The endotracheal tube (ETT) will be threaded over the bronchoscope
(aScope III) using the bronchoscope as a guide through the trachea.
10. Should the first attempt using the interventional method fail the next attempt will use
the standard Storz video-laryngoscope and #4 reusable blade along with the video
bronchoscope (aScope III)
11. There may be three attempts using the interventional method. Each attempt should be
less than 60 seconds. If the oxygen saturation decreases below 90% the attempt should
be aborted. The patient will be pre-oxygenated by mask between each attempt.
12. After three unsuccessful attempts the patient will be awaken and an "awake" intubation
procedure will take place.
13. The anesthesiologist will note any bleeding occurring during the procedure. Bleeding
will be assessed as minimal, moderate, and significant.
14. Study ends once the patient is intubated and breath sounds confirmed or when it is
decided an "awake" intubation is needed.
When randomized to the "interventional" group. (King Vision video-laryngoscope and #3
disposable blade and the video-bronchoscope (aScope III) The sequence of procedures will be:
1. Standard anesthesia monitoring which includes but is not limited to ECG, pulse
oximetry, capnography, blood pressure and temperature monitoring. Their head will be on
an anesthesia pillow. This is all standard procedure.
2. Anesthesiologist will induced with Fentanyl (1-2 ug/kg), propofol (2-4 mg/kg). This is
standard dosing.
3. Subjects will receive muscle relaxation using Rocuronium (0.6mg/kg)This is standard
dosing.
4. The patient will be pre-oxygenated for 2-3 minutes with 100% oxygen by mask to achieve
optimal oxygen saturation
5. Two anesthesiologist will perform the procedure
6. The video-laryngoscope will be used to visualize the glottis; the bronchoscope (aScope
III) will be inserted underneath the epiglottis and advance to the carina under direct
visualization. The endotracheal tube (ETT) will be threaded over the bronchoscope
(aScope III) using the bronchoscope as a guide through the trachea.
7. Should the first attempt fail to intubate the patient the next attempt will use the
Storz video- laryngoscope with a #4 reusable blade with the video-bronchoscope (aScope
III)
8. A total of three attempts may be made using the interventional method. Each attempt
should be less than 60 seconds and aborted if the oxygen saturation falls below 90%.
The patient will be pre-oxygenated by mask with 100% oxygen between each attempt.
9. If failure to intubate should occur the patient will be awaken and an "awake"
intubation will be performed.
10. The anesthesiologist will note any bleeding occurring during the procedure. Bleeding
will be assessed as minimal, moderate, and significant.
11. The study will end with successful intubation and confirmation of breath sounds or when
it is determined an "awake" intubation is necessary.
All subjects consented to this study will require endotracheal intubation. They will be
randomly assigned to either one of two groups. The randomization will be stratified on
whether the subject has an oral cavity/pharynx tumor or laryngeal tumor. The randomization
groups are:
1. Intubation using King Vision video-laryngoscope with the disposable #3 blade and a
stylet for placement of the endotracheal tube. This group is considered the "control
group".
2. Intubation using the King Vision video-laryngoscope with the disposable #3 blade and
the fiber-optic bronchoscope (aScope III). This group is considered the "interventional
group".
When randomized to the "control group" (King Vision video-laryngoscope with #3 disposable
blade and a stylet) the procedure sequence is as follows:
1. Standard anesthesia monitoring which includes but is not limited to ECG, pulse
oximetry, capnography, blood pressure and temperature monitoring. Their head will be on
an anesthesia pillow. This is all standard procedure.
2. Anesthesiologist will induced with Fentanyl (1-2 ug/kg), propofol (2-4 mg/kg). This is
standard dosing.
3. Subjects will receive muscle relaxation using Rocuronium (0.6mg/kg) This is standard
dosing.
4. The patient will be pre-oxygenated for 2-3 minutes with 100% oxygen by mask to achieve
optimal oxygen saturation
5. One anesthesiologist will perform the intubation procedure using the King Vision
video-laryngoscope with a #3 disposable blade and use a stylet to pre-form the
endotracheal tube (ETT).
6. If the anesthesiologist's first attempt to intubate should fail the next attempt will
use the standard Storz video-laryngoscope and a #4 reusable blade, a stylet to pre-form
the endotracheal tube (ETT) and with external laryngeal pressure. (BURP: back, up, and
rightward pressure)
7. The anesthesiologist may make a total of three attempts to intubate using the control
group procedures. Each attempt should be less than 60 seconds and will be aborted if
oxygen saturation falls below 90%. The patient will be pre-oxygenated by mask between
each attempt.
8. After three failed attempts to intubate the anesthesiologist will use the
interventional group method. Two anesthesiologists will be required to perform the
intubation using the King Vision video-laryngoscope with a #3 disposable blade and the
video bronchoscope (aScope III). The stylet will not be needed since the bronchoscope
will be used to guide the endotracheal tube (ETT).
9. The video-laryngoscope will be used to visualize the glottis; the bronchoscope (aScope
III) will be inserted underneath the epiglottis and advance to the carina under direct
visualization. The endotracheal tube (ETT) will be threaded over the bronchoscope
(aScope III) using the bronchoscope as a guide through the trachea.
10. Should the first attempt using the interventional method fail the next attempt will use
the standard Storz video-laryngoscope and #4 reusable blade along with the video
bronchoscope (aScope III)
11. There may be three attempts using the interventional method. Each attempt should be
less than 60 seconds. If the oxygen saturation decreases below 90% the attempt should
be aborted. The patient will be pre-oxygenated by mask between each attempt.
12. After three unsuccessful attempts the patient will be awaken and an "awake" intubation
procedure will take place.
13. The anesthesiologist will note any bleeding occurring during the procedure. Bleeding
will be assessed as minimal, moderate, and significant.
14. Study ends once the patient is intubated and breath sounds confirmed or when it is
decided an "awake" intubation is needed.
When randomized to the "interventional" group. (King Vision video-laryngoscope and #3
disposable blade and the video-bronchoscope (aScope III) The sequence of procedures will be:
1. Standard anesthesia monitoring which includes but is not limited to ECG, pulse
oximetry, capnography, blood pressure and temperature monitoring. Their head will be on
an anesthesia pillow. This is all standard procedure.
2. Anesthesiologist will induced with Fentanyl (1-2 ug/kg), propofol (2-4 mg/kg). This is
standard dosing.
3. Subjects will receive muscle relaxation using Rocuronium (0.6mg/kg)This is standard
dosing.
4. The patient will be pre-oxygenated for 2-3 minutes with 100% oxygen by mask to achieve
optimal oxygen saturation
5. Two anesthesiologist will perform the procedure
6. The video-laryngoscope will be used to visualize the glottis; the bronchoscope (aScope
III) will be inserted underneath the epiglottis and advance to the carina under direct
visualization. The endotracheal tube (ETT) will be threaded over the bronchoscope
(aScope III) using the bronchoscope as a guide through the trachea.
7. Should the first attempt fail to intubate the patient the next attempt will use the
Storz video- laryngoscope with a #4 reusable blade with the video-bronchoscope (aScope
III)
8. A total of three attempts may be made using the interventional method. Each attempt
should be less than 60 seconds and aborted if the oxygen saturation falls below 90%.
The patient will be pre-oxygenated by mask with 100% oxygen between each attempt.
9. If failure to intubate should occur the patient will be awaken and an "awake"
intubation will be performed.
10. The anesthesiologist will note any bleeding occurring during the procedure. Bleeding
will be assessed as minimal, moderate, and significant.
11. The study will end with successful intubation and confirmation of breath sounds or when
it is determined an "awake" intubation is necessary.
Inclusion Criteria:
- Patient will be eligible for the trial if they:
1. Have a tumor of the oral cavity, pharynx or larynx and are scheduled for biopsy
or resection requiring intubation of the trachea
2. Are 18 years or older
3. Sign the approved inform consent
Exclusion Criteria:
- Patients will be excluded from the study if:
1. Cannot lie down flat without suffering dyspnoea
2. Stridor
3. Full stomach
4. Hiatal hernia
5. Severe Gastroesophageal Reflux Disease (GERD) defined as already on a protein
pump inhibitor and continues to have daily regurgitation
6. Require rapid sequence intubation
We found this trial at
1
site
323 East Chestnut Street
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Phone: 502-852-3122
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