Clinical trial NCT03080896: Video-Laryngoscope Alone or With Bronchoscope for Predicted Difficult Intubation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Ambu A/S
First posted: 2017-03-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to successful intubation
timeFrame: From time full relaxation is achieved to time the patients is successfully intubated confirmed by breath sounds over a period of up to ten minutes
Secondary outcomes:
measure: Conversion from control group to intervention group
timeFrame: From the time full relaxation is achieved until the subject is successfully intubated confirmed by breath sounds over a period of up to ten minutes
measure: Number of intubation attempts until successful
timeFrame: From the time full relaxation is achieved until the time the subject is intubated; confirmed with breath sounds over a period of up to ten minutes
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Medical School, Department of Anesthesiology and Perioperative Medicine
state: Kentucky
Study officials:
affiliation: University of Louisville 530 South Jackson Street Louisville, KY 40202
name: Rainer Lenhardt, MD MBA
role: PRINCIPAL_INVESTIGATOR
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