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fiberoptic bronchoscope aScope III for Difficult Intubation (COMBO Trial)

N/A

Recruiting

Led By Rainer Lenhardt, MD MBA

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

COMBO Trial Summary

This trial found that using a video-laryngoscope in combination with a fiber-optic bronchoscope was a feasible way to successfully intubate patients with predicted difficult airways due to tumors in the oral cavity, pharynx, or larynx.

Who is the study for?

This trial is for adults over 18 who have tumors in the mouth, throat, or voice box and need a biopsy or surgery that requires intubation. They must understand and sign the consent form.Check my eligibility

What is being tested?

The study is testing if using a video-laryngoscope with a disposable fiber-optic bronchoscope (aScope III) is better than just the video-laryngoscope alone for safely placing a breathing tube in patients with difficult airways due to tumors.See study design

What are the potential side effects?

Potential side effects may include discomfort during intubation, sore throat after the procedure, possible injury to teeth or soft tissues of the mouth and throat, but specific risks will depend on individual patient factors.

COMBO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a tumor in my mouth or throat and need a biopsy or surgery that requires breathing tube placement.

Select...

I am 18 years old or older.

COMBO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to successful intubation

Secondary outcome measures

Conversion from control group to intervention group

Number of intubation attempts until successful

COMBO Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Interventional Group videolaryngoscope/fibeoptic bronchExperimental Treatment1 Intervention

The interventional group will Intubate using the video-laryngoscope and the fiber-optic bronchoscope (aScope III)

Group II: control group videolaryngoscope/preformed styletActive Control2 Interventions

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

338 Previous Clinical Trials

75,899 Total Patients Enrolled

Ambu A/SIndustry Sponsor

22 Previous Clinical Trials

5,544 Total Patients Enrolled

Rainer Lenhardt, MD MBAPrincipal Investigator - University of Louisville 530 South Jackson Street Louisville, KY 40202

University Of Louisville Research Foundation, University of Louisville Hospital

1 Previous Clinical Trials

12 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the cohort participating in this clinical trial?

"Affirmative. A cursory glance at clinicaltrials.gov reveals that this trial, first posted on April 10th 2017, is still recruiting participants. 80 individuals need to be enrolled across a single medical site."

Answered by AI

Does this trial still have spots open for participants?

"As noted on clinicaltrials.gov, this medical trial is currently recruiting patients to participate. The study was initially posted in April 2017 and last modified five years later on the 25th of the same month."

Answered by AI

Recent research and studies

AnaesthesiaJournal

Updating the Cormack and Lehane Classification

Kharbouch, H., and W. Peel. 2007. “Updating the Cormack and Lehane Classification”. Anaesthesia. Wiley. doi:10.1111/j.1365-2044.2007.05165.x.

Anaesthesia and Intensive CareJournal

Patient- and Operator-related Factors Associated with Successful Glidescope® Intubations: A Prospective Observational Study in 742 Patients

Siu, L. W. L., E. Mathieson, V. N. Naik, D. Chandra, and H. S. Joo. 2010. “Patient- and Operator-related Factors Associated with Successful Glidescope® Intubations: A Prospective Observational Study in 742 Patients”. Anaesthesia and Intensive Care. SAGE Publications. doi:10.1177/0310057x1003800113.

Canadian Journal of Anesthesia/Journal canadien d'anesthésieJournal

Use of a New Videolaryngoscope (glidescope®) in the Management of a Difficult Airway

Cooper, Richard M.. 2003. “Use of a New Videolaryngoscope (glidescope®) in the Management of a Difficult Airway”. Canadian Journal of Anesthesia/journal Canadien D'anesthésie. Springer Science and Business Media LLC. doi:10.1007/bf03018651.

Canadian Journal of Anesthesia/Journal canadien d'anesthésieJournal