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C-MAC Video Stylet vs. Video Endoscope for Intubation
N/A
Recruiting
Led By Lorenz Theiler, Prof., M.D
Research Sponsored by Insel Gruppe AG, University Hospital Bern
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up it cannot be longer than 240 seconds and is defined for unsuccessful trials, i.e. if no intubation was established, as 360 seconds.
Awards & highlights
Study Summary
This trial is comparing two ways of intubating patients to see which is more successful and efficient.
Who is the study for?
This trial is for anaesthesiologists who are new to using the C-MAC VS device, with minimal experience in fiberoptic oral intubation (no more than 5 times in the past year). They must be able to provide informed consent and complete case reports in English. Those not available throughout the study or experienced with the devices are excluded.Check my eligibility
What is being tested?
The study aims to compare two intubation tools: C-MAC Video Stylet (VS) and a standard flexible video endoscope. It will measure how successful each tool is on the first try and how long it takes to perform an intubation by anaesthesiologists learning these methods.See study design
What are the potential side effects?
Since this trial involves medical procedures rather than drugs, side effects may include potential complications related to intubation such as sore throat, difficulty swallowing, or less commonly, injury to teeth or airway structures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ it cannot be longer than 240 seconds and is defined for unsuccessful trials, i.e. if no intubation was established, as 360 seconds.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~it cannot be longer than 240 seconds and is defined for unsuccessful trials, i.e. if no intubation was established, as 360 seconds.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time (seconds) to successful orotracheal intubation during the first successful attempt.
Secondary outcome measures
Cormack/Lehane grade
Correlation to patients' anatomical characteristics
Limited or restricted vision through the devices (either C MAC VS or a standard flexible scope)
+13 moreOther outcome measures
How often a "hand over to specialist" happens
Incidence of injuries due to intubation attempts
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: C- MAC VSExperimental Treatment1 Intervention
Intubation with C- MAC VS
Group II: Video EndoscopeActive Control1 Intervention
Intubation with standard fiberoptic scope
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Who is running the clinical trial?
Insel Gruppe AG, University Hospital BernLead Sponsor
769 Previous Clinical Trials
1,810,553 Total Patients Enrolled
University Hospital Inselspital, BerneLead Sponsor
721 Previous Clinical Trials
2,254,444 Total Patients Enrolled
Lorenz Theiler, Prof., M.DPrincipal InvestigatorDepartment of Anaesthesiology and Pain Therapy
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been admitted into this scientific experiment?
"Indeed, according to information available on clinicaltrials.gov this investigation is actively recruiting participants. This research was initially published on December 15th 2018 and has been amended recently in December 6th 2022. 30 individuals are required for the trial at one medical centre."
Answered by AI
Are there any openings still available for prospective participants of this experiment?
"That is correct. According to clinicaltrials.gov, this medical trial which was initially advertised on December 15th 2018 is actively looking for participants. Approximately 30 patients need to be signed up from a single site."
Answered by AI
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