EmergencyNCT02297113
Rapid Sequence Intubation at the Emergency Department
A study testing Macintosh blade and C-MAC videolaryngoscope in people with Emergency, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency
- What is being tested?
- Macintosh blade and C-MAC videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zuerich, Dept of Anesthesiology
Zurich, Canton of Zurich, 8091
About this study
Official title: The C-MAC Videolaryngoscope Compared With Conventional Laryngoscopy for Rapid Sequence Intubation at the Emergency Department
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.
- Conditions
- Emergency
- Being tested
- Macintosh blade, C-MAC videolaryngoscope
- Keywords
- patients, departement, requiring Rapid Sequence Intubation (RSI)
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh bladeDevice
conventional endotracheal intubation
C-MAC videolaryngoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| conventional endotracheal intubation | Active comparator | Patients assigned to this group will be intubated using conventional Macintosh blade in adequate size. Receives: Device: Macintosh blade |
| C-MAC | Active comparator | Patients assigned to this group will be intubated using C-MAC videolaryngoscope in adequate size. Receives: Device: C-MAC videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
defined as successful placement of endotracheal tube within the trachea and
Measured: 10 minutes
Secondary outcomes (8)
time to intubation
defined as time between insertion of the videolaryngoscope/ Macintosh blade into the mouth until detection of end-tidal CO2
Measured: 10 minutes
Laryngoscopic view
Cormack and Lehane Score
Measured: 10 minutes
Number of intubation attempts
Measured: 10 minutes
Unrecognized esophageal intubation
Measured: 10 minutes
Ease of intubation (1-5)
- (1) very easy, (2) easy, (3) somewhat difficult, (4) difficult, (5) impossible
Measured: 10 minutes
Violations of the teeth
number of patients; teeth will be inspected for potential damage and documented accordingly
Measured: 10 minutes
Necessity of using further, alternative airway devices for successful intubation (if randomized airway device failed)
number of patients, requiring alternate device
Measured: 10 minutes
Maximum drop of saturation
Spo2 will be measured continuously and documented accordingly
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EmergencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297113
- Sponsor's protocol ID
- KEK Zurich 2014-0356
- Status last verified
- Mar 2016
- First submitted
- 13 Nov 2014
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25903358Sulser 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.
PubMed 27533711
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The C-MAC Videolaryngoscope Compared With Conventional Laryngoscopy for Rapid Sequence Intubation at the Emergency Department
- ClinicalTrials.gov ID
- NCT02297113
- Acronym / sponsor ID
- KEK Zurich 2014-0356
- Conditions
- Emergency
- Keywords
- patients, departement, requiring Rapid Sequence Intubation (RSI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional endotracheal intubation | Active comparator | Device: Macintosh bladePatients assigned to this group will be intubated using conventional Macintosh blade in adequate size. |
| C-MAC | Active comparator | Device: C-MAC videolaryngoscopePatients assigned to this group will be intubated using C-MAC videolaryngoscope in adequate size. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macintosh bladeconventional endotracheal intubation | Device | conventional endotracheal intubation |
| C-MAC videolaryngoscope | Device | C-MAC |
Primary outcome
Success Rate
Time frame: 10 minutes
defined as successful placement of endotracheal tube within the trachea and
8 secondary outcomes
time to intubation
Time frame: 10 minutes
Laryngoscopic view
Time frame: 10 minutes
Number of intubation attempts
Time frame: 10 minutes
Unrecognized esophageal intubation
Time frame: 10 minutes
Ease of intubation (1-5)
Time frame: 10 minutes
Violations of the teeth
Time frame: 10 minutes
Necessity of using further, alternative airway devices for successful intubation (if randomized airway device failed)
Time frame: 10 minutes
Maximum drop of saturation
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Background: PubMed 25903358Sulser 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.
- Derived from this study: PubMed 27533711Sulser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh blade and C-MAC videolaryngoscope in people with Emergency, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02297113, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.