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Video-Laryngoscope Alone or With Bronchoscope for Predicted Difficult Intubation (COMBO)

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ClinicalTrials.gov Identifier: NCT03080896
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
Ambu A/S
Information provided by (Responsible Party):
Rainer Lenhardt, University of Louisville

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

Condition or disease Intervention/treatment Phase
Intubation; Difficult Device: King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet Device: fiberoptic bronchoscope aScope III Not Applicable

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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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Active Comparator: control group videolaryngoscope/preformed stylet
The control group will intubate using the video-laryngoscope / pre formed stylet. Will convert to using video-laryngoscope and fiber-optic bronchoscope (aScope III) if failure to intubate occurs
Device: King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet
intubation using King Vision video-laryngoscope with #3 disposable blade with stylet convert to intubation with video-laryngoscope and fiber-optic bronchoscope bronchoscope (aScope III) for failure to intubate after three attempts
Other Name: Ambu aScope III
Device: fiberoptic bronchoscope aScope III
Intubation using the videolaryngoscope/fiberoptic bronchoscope (aScope III)
Other Name: aScope III by Ambu
Experimental: Interventional Group videolaryngoscope/fibeoptic bronch
The interventional group will Intubate using the video-laryngoscope and the fiber-optic bronchoscope (aScope III)
Device: fiberoptic bronchoscope aScope III
Intubation using the videolaryngoscope/fiberoptic bronchoscope (aScope III)
Other Name: aScope III by Ambu



Primary Outcome Measures :
  1. Time to successful intubation [ Time Frame: 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 ]
    measured in seconds


Secondary Outcome Measures :
  1. Conversion from control group to intervention group [ Time Frame: 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 ]
    Number of subjects randomized to control group who require to be treated with the method of the intervention group

  2. Number of intubation attempts until successful [ Time Frame: 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 ]
    whole numbers of attempts



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080896


Contacts
Contact: Rainer Lenhardt, MD, MBA 502852-3122 rainer.lenhardt@louisville.edu
Contact: Elizabeth A Cooke, RN BSN CCRP 502-852-8016 eacooke02@louisville.edu

Locations
United States, Kentucky
University of Louisville Medical School, Department of Anesthesiology and Perioperative Medicine Recruiting
Louisville, Kentucky, United States, 40202
Contact: Reiner Lenhardt, MD MBA    502-852-3122    reiner.lenhardt@louisville.edu   
Contact: Elizabeth Cooke, RN BSN CCRP    502-852-8016    eacook02@louisville.edu   
Sponsors and Collaborators
University of Louisville
Ambu A/S
Investigators
Principal Investigator: Rainer Lenhardt, MD MBA University of Louisville 530 South Jackson Street Louisville, KY 40202

Publications of Results:
Other Publications:
Responsible Party: Rainer Lenhardt, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT03080896     History of Changes
Other Study ID Numbers: IRB #15.0096
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: individual patients data will not be shared. Results or the studies findings will be published

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No