Rapid Sequence Intubation at the Emergency Department

Study Overview
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Brief Summary
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All patients undergoing emergent endotracheal intubation (RSI) at the Emergency Department will be screened for inclusion in this clinical study. The indication of endotracheal intubation is an exclusively clinical decision and is not affected by this study protocol in any aspect. If fulfilling the In- and exclusion criteria's, patient will be randomly assigned to one of two groups C-MAC Videolaryngoscope in appropriate size conventional endotracheal intubation using Macintosh Blade in appropriate size Randomization (1:1) will be based on computer-generated codes maintained in sequentially numbered opaque envelopes that will be opened immediately before randomization.

Official Title
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The C-MAC Videolaryngoscope Compared With Conventional Laryngoscopy for Rapid Sequence Intubation at the Emergency Department

Conditions
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Emergency

Intervention / Treatment
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* Device: Macintosh blade
* Device: C-MAC videolaryngoscope


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional endotracheal intubation<br>Patients assigned to this group will be intubated using conventional Macintosh blade in adequate size. | Device: Macintosh blade<br>* conventional endotracheal intubation<br>|
| Active Comparator: C-MAC<br>Patients assigned to this group will be intubated using C-MAC videolaryngoscope in adequate size. | Device: C-MAC videolaryngoscope<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate | defined as successful placement of endotracheal tube within the trachea and | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to intubation | defined as time between insertion of the videolaryngoscope/ Macintosh blade into the mouth until detection of end-tidal CO2 | 10 minutes | 
| Laryngoscopic view | Cormack and Lehane Score | 10 minutes | 
| Number of intubation attempts |  | 10 minutes | 
| Unrecognized esophageal intubation |  | 10 minutes | 
| Ease of intubation (1-5) | o (1) very easy, (2) easy, (3) somewhat difficult, (4) difficult, (5) impossible | 10 minutes | 
| Violations of the teeth | number of patients; teeth will be inspected for potential damage and documented accordingly | 10 minutes | 
| Necessity of using further, alternative airway devices for successful intubation (if randomized airway device failed) | number of patients, requiring alternate device | 10 minutes | 
| Maximum drop of saturation | Spo2 will be measured continuously and documented accordingly | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patients, departement, requiring Rapid Sequence Intubation (RSI)