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 : July 31, 2019
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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 |

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 : | December 2020 |
Estimated Study Completion Date : | December 2020 |
Arm | Intervention/treatment |
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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
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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)
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Device: fiberoptic bronchoscope aScope III
Intubation using the videolaryngoscope/fiberoptic bronchoscope (aScope III)
Other Name: aScope III by Ambu |
- 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
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
Exclusion Criteria:
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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

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
Contact: Rainer Lenhardt, MD, MBA | 502852-3122 | rainer.lenhardt@louisville.edu | |
Contact: Elizabeth A Cooke, RN BSN CCRP | 502-852-8016 | eacooke02@louisville.edu |
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 |
Principal Investigator: | Rainer Lenhardt, MD MBA | University of Louisville 530 South Jackson Street Louisville, KY 40202 |
Other Publications:
Responsible Party: | Rainer Lenhardt, Professor, University of Louisville |
ClinicalTrials.gov Identifier: | NCT03080896 |
Other Study ID Numbers: |
IRB #15.0096 |
First Posted: | March 15, 2017 Key Record Dates |
Last Update Posted: | July 31, 2019 |
Last Verified: | July 2019 |
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 |