Back to resultsRapid Sequence Intubation at the Emergency Department
Primary Purpose
Emergency
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Macintosh blade
C-MAC videolaryngoscope
Sponsored by
About this trial
This is an interventional treatment trial for Emergency focused on measuring patients, departement, requiring Rapid Sequence Intubation (RSI)
Eligibility Criteria
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
Sites / Locations
- University Hospital Zuerich, Dept of Anesthesiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
conventional endotracheal intubation
C-MAC
Arm Description
Patients assigned to this group will be intubated using conventional Macintosh blade in adequate size.
Patients assigned to this group will be intubated using C-MAC videolaryngoscope in adequate size.
Outcomes
Primary Outcome Measures
Success Rate
defined as successful placement of endotracheal tube within the trachea and
Secondary Outcome Measures
time to intubation
defined as time between insertion of the videolaryngoscope/ Macintosh blade into the mouth until detection of end-tidal CO2
Laryngoscopic view
Cormack and Lehane Score
Number of intubation attempts
Unrecognized esophageal intubation
Ease of intubation (1-5)
o (1) very easy, (2) easy, (3) somewhat difficult, (4) difficult, (5) impossible
Violations of the teeth
number of patients; teeth will be inspected for potential damage and documented accordingly
Necessity of using further, alternative airway devices for successful intubation (if randomized airway device failed)
number of patients, requiring alternate device
Maximum drop of saturation
Spo2 will be measured continuously and documented accordingly
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02297113
Brief Title
Rapid Sequence Intubation at the Emergency Department
Official Title
The C-MAC Videolaryngoscope Compared With Conventional Laryngoscopy for Rapid Sequence Intubation at the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency
Keywords
patients, departement, requiring Rapid Sequence Intubation (RSI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional endotracheal intubation
Arm Type
Active Comparator
Arm Description
Patients assigned to this group will be intubated using conventional Macintosh blade in adequate size.
Arm Title
C-MAC
Arm Type
Active Comparator
Arm Description
Patients assigned to this group will be intubated using C-MAC videolaryngoscope in adequate size.
Intervention Type
Device
Intervention Name(s)
Macintosh blade
Intervention Description
conventional endotracheal intubation
Intervention Type
Device
Intervention Name(s)
C-MAC videolaryngoscope
Primary Outcome Measure Information:
Title
Success Rate
Description
defined as successful placement of endotracheal tube within the trachea and
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
time to intubation
Description
defined as time between insertion of the videolaryngoscope/ Macintosh blade into the mouth until detection of end-tidal CO2
Time Frame
10 minutes
Title
Laryngoscopic view
Description
Cormack and Lehane Score
Time Frame
10 minutes
Title
Number of intubation attempts
Time Frame
10 minutes
Title
Unrecognized esophageal intubation
Time Frame
10 minutes
Title
Ease of intubation (1-5)
Description
o (1) very easy, (2) easy, (3) somewhat difficult, (4) difficult, (5) impossible
Time Frame
10 minutes
Title
Violations of the teeth
Description
number of patients; teeth will be inspected for potential damage and documented accordingly
Time Frame
10 minutes
Title
Necessity of using further, alternative airway devices for successful intubation (if randomized airway device failed)
Description
number of patients, requiring alternate device
Time Frame
10 minutes
Title
Maximum drop of saturation
Description
Spo2 will be measured continuously and documented accordingly
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital Zuerich, Dept of Anesthesiology
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
25903358
Citation
Sulser S, Ubmann D, Brueesch M, Goliasch G, Seifert B, Spahn DR, Ruetzler K. The C-MAC videolaryngoscope compared with conventional laryngoscopy for rapid sequence intubation at the emergency department: study protocol. Scand J Trauma Resusc Emerg Med. 2015 Apr 24;23:38. doi: 10.1186/s13049-015-0119-x.
Results Reference
background
PubMed Identifier
27533711
Citation
Sulser S, Ubmann D, Schlaepfer M, Brueesch M, Goliasch G, Seifert B, Spahn DR, Ruetzler K. C-MAC videolaryngoscope compared with direct laryngoscopy for rapid sequence intubation in an emergency department: A randomised clinical trial. Eur J Anaesthesiol. 2016 Dec;33(12):943-948. doi: 10.1097/EJA.0000000000000525.
Results Reference
derived
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Rapid Sequence Intubation at the Emergency Department
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