Endotracheal IntubationNCT02733536
Intubation During Spinal Immobilization
A study testing Standard endotracheal tube and C-MAC in people with Endotracheal Intubation, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim was to evaluate the performance of the C-MAC compared with Macintosh when performed in patients with immobilized cervical spine by unexperienced physicians. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Standard endotracheal tube and C-MAC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2016to Apr 2017
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- give voluntary consent to participate in the study
- limited experience (<5 intubations) with "real-life" intubation using direct laryngoscopy
- novice phhysicians
Who cannot join
- not meet the above criteria
- practice with any videolaryngoscopy
- wrist or low back diseases
- pregnancy
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Warsaw, Department of Emergency Medicine
Warsaw, Masovia, 02-005
About this study
Official title: C-MAC Compared to Direct Laryngoscopy in Patients With Immobilized Cervical Spine by Unexperienced Physicians: A Randomized Crossover Manikin Trial
The aim was to evaluate the performance of the C-MAC compared with Macintosh when performed in patients with immobilized cervical spine by unexperienced physicians.
- Conditions
- Endotracheal Intubation
- Being tested
- Standard endotracheal tube, C-MAC
- Keywords
- endotracheal intubation, trauma, paramedic
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard endotracheal tubeDevice
- Direct laryngoscopy using a Macintosh laryngoscope with size 3 blade (Mercury Medical, Clearwater, FL, USA) with a conventional 7.0 mm internal diameter (ID) tracheal tube
C-MACDevice
C-MAC introduced with a h size 3 blade.
| Study group | Role | What they receive |
|---|---|---|
| Scenario A | Experimental | manikin with normal standard airway Receives: Device: Standard endotracheal tube; Device: C-MAC |
| Scenario B | Experimental | Cervical immobilization using a standard Patriot cervical extraction collar (Oessur Americas, Foothill Ranch, CA, USA), applied to the manikin's neck by an instructor. Receives: Device: Standard endotracheal tube; Device: C-MAC |
| Scenario C | Experimental | Cervical immobilization using a vacuum mattress (Ferno-Washington, Inc. Wilmington, OH, USA), applied to the manikin's neck by an instructor Receives: Device: Standard endotracheal tube; Device: C-MAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required for successful intubation
Measured: 1 day
Secondary outcomes (4)
success rate of intubation attempt
success rate of first intubation attempt
Measured: 1 day
Cormack&Lehane grade
glottic view during intubation rate using Cormack\&Lehane grade
Measured: 1 day
Dental Compression
the severity of the potential dental trauma was calculated based on previously described modified grading scale (Svoldelli, 2009)
Measured: 1 day
Ease of intubation
To access subjective opinion about the difficulty of each intubation method, participants were asked to rate it on a visual analog scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startDec 2016
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Endotracheal IntubationStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Szarpak, Medical University of Warsaw
- Investigators
- Łukasz Szarpak, PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733536
- Sponsor's protocol ID
- 23.01.2017.IRB
- Status last verified
- Jul 2017
- First submitted
- 5 Apr 2016
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Truszewski Z, Szarpak L, Smereka J, Kurowski A, Evrin T, Czyzewski L. Comparison of the VivaSight single lumen endotracheal tube and the Macintosh laryngoscope for emergency intubation by experienced paramedics in a standardized airway manikin with restricted access: a randomized, crossover trial. Am J Emerg Med. 2016 May;34(5):929-30. doi: 10.1016/j.ajem.2016.02.054. Epub 2016 Feb 27. No abstract available.
PubMed 26979260Bogdanski L, Truszewski Z, Kurowski A, Czyzewski L, Zasko P, Adamczyk P, Szarpak L. Simulated endotracheal intubation of a patient with cervical spine immobilization during resuscitation: a randomized comparison of the Pentax AWS, the Airtraq, and the McCoy Laryngoscopes. Am J Emerg Med. 2015 Dec;33(12):1814-7. doi: 10.1016/j.ajem.2015.09.005. Epub 2015 Sep 21.
PubMed 26494629Gawlowski P, Smereka J, Madziala M, Szarpak L, Frass M, Robak O. Comparison of the Macintosh laryngoscope and blind intubation via the iGEL for Intubation With C-spine immobilization: A Randomized, crossover, manikin trial. Am J Emerg Med. 2017 Mar;35(3):484-487. doi: 10.1016/j.ajem.2016.11.064. Epub 2016 Nov 30.
PubMed 28041757Karczewska K, Szarpak L, Smereka J, Dabrowski M, Ladny JR, Wieczorek W, Robak O, Frass M, Ahuja S, Ruetzler K. ET-View compared to direct laryngoscopy in patients with immobilized cervical spine by unexperienced physicians: A randomized crossover manikin trial. Anaesthesiol Intensive Ther. 2017;49(4):274-282. doi: 10.5603/AIT.a2017.0047. Epub 2017 Sep 27.
PubMed 28953308Truszewski Z, Krajewski P, Fudalej M, Smereka J, Frass M, Robak O, Nguyen B, Ruetzler K, Szarpak L. A comparison of a traditional endotracheal tube versus ETView SL in endotracheal intubation during different emergency conditions: A randomized, crossover cadaver trial. Medicine (Baltimore). 2016 Nov;95(44):e5170. doi: 10.1097/MD.0000000000005170.
PubMed 27858851
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-MAC Compared to Direct Laryngoscopy in Patients With Immobilized Cervical Spine by Unexperienced Physicians: A Randomized Crossover Manikin Trial
- ClinicalTrials.gov ID
- NCT02733536
- Acronym / sponsor ID
- 23.01.2017.IRB
- Conditions
- Endotracheal Intubation
- Keywords
- endotracheal intubation, trauma, paramedic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 11 Apr 2016 (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.
The aim was to evaluate the performance of the C-MAC compared with Macintosh when performed in patients with immobilized cervical spine by unexperienced physicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scenario A | Experimental | Device: Standard endotracheal tube, Device: C-MACmanikin with normal standard airway |
| Scenario B | Experimental | Device: Standard endotracheal tube, Device: C-MACCervical immobilization using a standard Patriot cervical extraction collar (Oessur Americas, Foothill Ranch, CA, USA), applied to the manikin's neck by an instructor. |
| Scenario C | Experimental | Device: Standard endotracheal tube, Device: C-MACCervical immobilization using a vacuum mattress (Ferno-Washington, Inc. Wilmington, OH, USA), applied to the manikin's neck by an instructor |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- give voluntary consent to participate in the study
- limited experience (<5 intubations) with "real-life" intubation using direct laryngoscopy
- novice phhysicians
Key exclusion criteria (4 listed)
- not meet the above criteria
- practice with any videolaryngoscopy
- wrist or low back diseases
- pregnancy
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 |
|---|---|---|
| Standard endotracheal tube1) Direct laryngoscopy using a Macintosh laryngoscope with size 3 blade (Mercury Medical, Clearwater, FL, USA) with a conventional 7.0 mm internal diameter (ID) tracheal tube | Device | Scenario A, Scenario B, Scenario C |
| C-MACC-MAC introduced with a h size 3 blade. | Device | Scenario A, Scenario B, Scenario C |
Primary outcome
Time required for successful intubation
Time frame: 1 day
4 secondary outcomes
success rate of intubation attempt
Time frame: 1 day
Cormack&Lehane grade
Time frame: 1 day
Dental Compression
Time frame: 1 day
Ease of intubation
Time frame: 1 day
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 27 Jul 2017.
- Background: PubMed 26979260Truszewski Z, Szarpak L, Smereka J, Kurowski A, Evrin T, Czyzewski L. Comparison of the VivaSight single lumen endotracheal tube and the Macintosh laryngoscope for emergency intubation by experienced paramedics in a standardized airway manikin with restricted access: a randomized, crossover trial. Am J Emerg Med. 2016 May;34(5):929-30. doi: 10.1016/j.ajem.2016.02.054. Epub 2016 Feb 27. No abstract available.
- Background: PubMed 26494629Bogdanski L, Truszewski Z, Kurowski A, Czyzewski L, Zasko P, Adamczyk P, Szarpak L. Simulated endotracheal intubation of a patient with cervical spine immobilization during resuscitation: a randomized comparison of the Pentax AWS, the Airtraq, and the McCoy Laryngoscopes. Am J Emerg Med. 2015 Dec;33(12):1814-7. doi: 10.1016/j.ajem.2015.09.005. Epub 2015 Sep 21.
- Background: PubMed 28041757Gawlowski P, Smereka J, Madziala M, Szarpak L, Frass M, Robak O. Comparison of the Macintosh laryngoscope and blind intubation via the iGEL for Intubation With C-spine immobilization: A Randomized, crossover, manikin trial. Am J Emerg Med. 2017 Mar;35(3):484-487. doi: 10.1016/j.ajem.2016.11.064. Epub 2016 Nov 30.
- Derived from this study: PubMed 28953308Karczewska K, Szarpak L, Smereka J, Dabrowski M, Ladny JR, Wieczorek W, Robak O, Frass M, Ahuja S, Ruetzler K. ET-View compared to direct laryngoscopy in patients with immobilized cervical spine by unexperienced physicians: A randomized crossover manikin trial. Anaesthesiol Intensive Ther. 2017;49(4):274-282. doi: 10.5603/AIT.a2017.0047. Epub 2017 Sep 27.
- Derived from this study: PubMed 27858851Truszewski Z, Krajewski P, Fudalej M, Smereka J, Frass M, Robak O, Nguyen B, Ruetzler K, Szarpak L. A comparison of a traditional endotracheal tube versus ETView SL in endotracheal intubation during different emergency conditions: A randomized, crossover cadaver trial. Medicine (Baltimore). 2016 Nov;95(44):e5170. doi: 10.1097/MD.0000000000005170.
- Individual participant dataSharing planned: Undecided
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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.
Łukasz Szarpak, PhD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard endotracheal tube and C-MAC in people with Endotracheal Intubation, run by Medical University of Warsaw at 1 site in Poland.
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 3 inclusion and 4 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 27 Jul 2017. 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 Poland. 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?
Time required for successful intubation (time frame: 1 day). 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 NCT02733536, which also lists 5 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 27 Jul 2017.