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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT02297113 |
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Date of registration:
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13/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rapid Sequence Intubation at the Emergency Department
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Scientific title:
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The C-MAC Videolaryngoscope Compared With Conventional Laryngoscopy for Rapid Sequence Intubation at the Emergency Department |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02297113 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients requiring emergency Rapid Sequence Intubation at the emergency department
- Male and Female subjects 18 years to 99 years of age
- Written confirmation by a physician not involved in this study
- Written informed consent by the participant (obtained afterwards)
- Patient not showing remarkable rejection in participation in this study
Exclusion Criteria:
- Maxilla-Facial trauma
- Immobilized cervical spine
- Indication for fiberoptic guided intubation (known difficult airway)
- Ongoing Cardio-Pulmonary-Resuscitation (CPR)
- Involvement in any other clinical trial during the course of this trial, within a
period of 30 days prior to its beginning or 30 days after its completion
- Severe or immediately life-treating injury requiring immediate medical treatment
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Emergency
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Intervention(s)
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Device: C-MAC videolaryngoscope
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Device: Macintosh blade
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Primary Outcome(s)
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Success Rate
[Time Frame: 10 minutes]
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Secondary Outcome(s)
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Violations of the teeth
[Time Frame: 10 minutes]
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Laryngoscopic view
[Time Frame: 10 minutes]
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Ease of intubation (1-5)
[Time Frame: 10 minutes]
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Maximum drop of saturation
[Time Frame: 10 minutes]
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time to intubation
[Time Frame: 10 minutes]
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Number of intubation attempts
[Time Frame: 10 minutes]
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Unrecognized esophageal intubation
[Time Frame: 10 minutes]
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Necessity of using further, alternative airway devices for successful intubation (if randomized airway device failed)
[Time Frame: 10 minutes]
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Secondary ID(s)
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KEK Zurich 2014-0356
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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