AzTrials
AzTrials

Intubation; DifficultCOMBONCT03080896

Video-Laryngoscope Alone or With Bronchoscope for Predicted Difficult Intubation

A study testing King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet and fiberoptic bronchoscope aScope III in people with Intubation; Difficult, run by University of Louisville at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intubation; Difficult
What is being tested?
King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet and fiberoptic bronchoscope aScope III
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
10 Apr 2017to 31 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient will be eligible for the trial if they:
  • Have a tumor of the oral cavity, pharynx or larynx and are scheduled for biopsy or resection requiring intubation of the trachea
  • Are 18 years or older
  • Sign the approved inform consent

Who cannot join

  • Patients will be excluded from the study if:
  • Cannot lie down flat without suffering dyspnoea
  • Stridor
  • Full stomach
  • Hiatal hernia
  • Severe Gastroesophageal Reflux Disease (GERD) defined as already on a protein pump inhibitor and continues to have daily regurgitation
  • Require rapid sequence intubation

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Louisville Medical School, Department of Anesthesiology and Perioperative Medicine

    Louisville, Kentucky, 40202

Other trials in United States

About this study

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

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

Read the 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.
Being tested
King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet, fiberoptic bronchoscope aScope III

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • King Vision video-laryngoscope with #3 disposable blade and endotracheal tube styletDevice

    Also called Ambu aScope III

    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

  • fiberoptic bronchoscope aScope IIIDevice

    Also called aScope III by Ambu

    Intubation using the videolaryngoscope/fiberoptic bronchoscope (aScope III)

Study groups in NCT03080896
Study groupRoleWhat they receive
control group videolaryngoscope/preformed styletActive comparatorThe 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
Receives: Device: King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet; Device: fiberoptic bronchoscope aScope III
Interventional Group videolaryngoscope/fibeoptic bronchExperimentalThe interventional group will Intubate using the video-laryngoscope and the fiber-optic bronchoscope (aScope III)
Receives: Device: fiberoptic bronchoscope aScope III

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to successful intubation

    measured in seconds

    Measured: 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 (2)
  1. Conversion from control group to intervention group

    Number of subjects randomized to control group who require to be treated with the method of the intervention group

    Measured: 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

  2. Number of intubation attempts until successful

    whole numbers of attempts

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2017
  2. Study start10 Apr 2017
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03080896
Sponsor's protocol ID
IRB #15.0096
Acronym
COMBO
Status last verified
May 2024
First submitted
27 Jan 2017
Last updated
28 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: individual patients data will not be shared. Results or the studies findings will be published

Publications

  • Juneja R, Lacey O. Anaesthesia for head and neck cancer surgery. Curr Anaesth Crit Care 2009;20:28-32.

  • Stacey M, Rassam S, Sivasankar R, Hall J. Difficulty in advancing a tracheal tube over a fibreoptic bronchoscope: more solutions. Br J Anaesth. 2005 Jul;95(1):112. doi: 10.1093/bja/aei570. No abstract available.

    PubMed 15941739
  • Cooper RM. Use of a new videolaryngoscope (GlideScope) in the management of a difficult airway. Can J Anaesth. 2003 Jun-Jul;50(6):611-3. doi: 10.1007/BF03018651.

    PubMed 12826557
  • Doyle DJ. GlideScope-assisted fiberoptic intubation: a new airway teaching method. Anesthesiology. 2004 Nov;101(5):1252. doi: 10.1097/00000542-200411000-00046. No abstract available.

    PubMed 15505482
  • Turkstra TP, Harle CC, Armstrong KP, Armstrong PM, Cherry RA, Hoogstra J, Jones PM. The GlideScope-specific rigid stylet and standard malleable stylet are equally effective for GlideScope use. Can J Anaesth. 2007 Nov;54(11):891-6. doi: 10.1007/BF03026792.

    PubMed 17975233
  • Turkstra TP, Jones PM, Ower KM, Gros ML. The Flex-It stylet is less effective than a malleable stylet for orotracheal intubation using the GlideScope. Anesth Analg. 2009 Dec;109(6):1856-9. doi: 10.1213/ANE.0b013e3181bc116a.

    PubMed 19923515
  • Knill RL. Difficult laryngoscopy made easy with a "BURP". Can J Anaesth. 1993 Mar;40(3):279-82. doi: 10.1007/BF03037041.

    PubMed 8467551
  • Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

    PubMed 6507827
  • Janda M, Scheeren TW, Noldge-Schomburg GF. Management of pulmonary aspiration. Best Pract Res Clin Anaesthesiol. 2006 Sep;20(3):409-27. doi: 10.1016/j.bpa.2006.02.006.

    PubMed 17080693
  • Fasting S, Gisvold SE. Serious intraoperative problems--a five-year review of 83,844 anesthetics. Can J Anaesth. 2002 Jun-Jul;49(6):545-53. doi: 10.1007/BF03017379.

    PubMed 12067864
  • Siu LW, Mathieson E, Naik VN, Chandra D, Joo HS. Patient- and operator-related factors associated with successful Glidescope intubations: a prospective observational study in 742 patients. Anaesth Intensive Care. 2010 Jan;38(1):70-5. doi: 10.1177/0310057X1003800113.

    PubMed 20191780
  • Van Zundert AA, Hermans B, Kuczkowski KM. Successful use of a videolaryngoscope in a patient with carcinoma of the oropharynx and obstructed airway. Minerva Anestesiol. 2009 Jul-Aug;75(7-8):475-6. No abstract available.

    PubMed 19571781
  • Lenhardt R, Burkhart MT, Brock GN, Kanchi-Kandadai S, Sharma R, Akca O. Is video laryngoscope-assisted flexible tracheoscope intubation feasible for patients with predicted difficult airway? A prospective, randomized clinical trial. Anesth Analg. 2014 Jun;118(6):1259-65. doi: 10.1213/ANE.0000000000000220.

    PubMed 24842175

Questions about this trial

What is this clinical trial studying?

A study testing King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet and fiberoptic bronchoscope aScope III in people with Intubation; Difficult, run by University of Louisville at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03080896, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in