Spinal InjuriesNCT02382887
Comparison by Neuromonitoring of Two Techniques of Tracheal Intubation in Patients With Unstable Cervical Spine
A study testing tracheal intubation, Airtraq and fiberscope in people with Spinal Injuries, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery. Commonly, the management of the tracheal intubation is performed by a fiberoptic technique. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Injuries
- What is being tested?
- tracheal intubation, Airtraq and fiberscope
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2009to 1 Aug 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- unstable cervical spine due to a cervical vertebra fracture
- American Society of Anesthesia classification 1-3
- BMI < 30 kg/m2
- patients necessitating a general anesthesia for surgery
Who cannot join
- patient refusal
- ASA >3
- mouth opening < 15mm
- patients with known history of previous orotracheal tumor surgery
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dpt of Anesthesiology, University of Lausanne CHUV
Lausanne, Canton of Vaud, 1011
About this study
Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery.
Commonly, the management of the tracheal intubation is performed by a fiberoptic technique.
However, changes in equipment availability and quality may challenge the fiberoptic intubation technique.
The investigators wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique.
Read the detailed description
Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery.
Commonly, the management of the tracheal intubation is performed by a fiberoptic technique (historic gold standard technique).
However, changes in equipment availability and quality may challenge the fiberoptic intubation technique.
We wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique.
Primary outcomes will be the changes in neurophysiologic responses monitored by a neurophysiologist in 5 specific phases:
- Basal potential (BM): neuromonitoring while the patient is anesthetized, no movements
- Ventilation potential (VM): neuromonitoring while the patient is anesthetized and a bag-mask ventilation is performed
- Intubation potential (IP): neuromonitoring while the patient is being intubated with one of the two randomized devices
- Post Intubation (PI): neuromonitoring after the patient has been intubated
- Post Positioning (PP): neuromonitoring after the patient has been properly positioned on the operating table and is ready for surgery
- Conditions
- Spinal Injuries
- Being tested
- tracheal intubation, Airtraq, fiberscope
- Keywords
- intubation, difficult airway, fiberscopy, Airtraq, general anesthesia
- Medical subject headings
- Spinal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tracheal intubationProcedure or surgery
tracheal intubation with the Airtraq
AirtraqDevice
fiberscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Tracheal intubation with Fiberscopy | Active comparator | tracheal intubation with a fiberscope Receives: Procedure: tracheal intubation; Device: fiberscope |
| Tracheal intubation with Airtraq | Experimental | tracheal intubation with an Airtraq Receives: Procedure: tracheal intubation; Device: Airtraq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromonitoring modifications (modifications appearing on the neuromonitoring)
modifications appearing on the neuromonitoring during the 5 different phases
Measured: 30 seconds
Secondary outcomes (3)
time necessary for tracheal intubation
Measured: 180 seconds
tracheal inlet view (best view during intubation)
best view during intubation
Measured: 10 seconds
number of attempts necessary
Measured: 180 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startMar 2009
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal InjuriesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schoettker,MD PD, University of Lausanne Hospitals
- Investigators
- Patrick Schoettker, MD, PD, Principal investigator, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382887
- Sponsor's protocol ID
- 225/08
- Status last verified
- Dec 2017
- First submitted
- 3 Mar 2015
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison by Neuromonitoring of Two Techniques of Tracheal Intubation in Patients With Unstable Cervical Spine
- ClinicalTrials.gov ID
- NCT02382887
- Acronym / sponsor ID
- 225/08
- Conditions
- Spinal Injuries
- Keywords
- intubation, difficult airway, fiberscopy, Airtraq, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Mar 2009 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 9 Mar 2015 (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.
Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery.
Commonly, the management of the tracheal intubation is performed by a fiberoptic technique.
However, changes in equipment availability and quality may challenge the fiberoptic intubation technique.
The investigators wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique.
Detailed description
Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery.
Commonly, the management of the tracheal intubation is performed by a fiberoptic technique (historic gold standard technique).
However, changes in equipment availability and quality may challenge the fiberoptic intubation technique.
We wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique.
Primary outcomes will be the changes in neurophysiologic responses monitored by a neurophysiologist in 5 specific phases:
- Basal potential (BM): neuromonitoring while the patient is anesthetized, no movements
- Ventilation potential (VM): neuromonitoring while the patient is anesthetized and a bag-mask ventilation is performed
- Intubation potential (IP): neuromonitoring while the patient is being intubated with one of the two randomized devices
- Post Intubation (PI): neuromonitoring after the patient has been intubated
- Post Positioning (PP): neuromonitoring after the patient has been properly positioned on the operating table and is ready for surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tracheal intubation with Fiberscopy | Active comparator | Procedure: tracheal intubation, Device: fiberscopetracheal intubation with a fiberscope |
| Tracheal intubation with Airtraq | Experimental | Procedure: tracheal intubation, Device: Airtraqtracheal intubation with an Airtraq |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- unstable cervical spine due to a cervical vertebra fracture
- American Society of Anesthesia classification 1-3
- BMI < 30 kg/m2
- patients necessitating a general anesthesia for surgery
Key exclusion criteria (4 listed)
- patient refusal
- ASA >3
- mouth opening < 15mm
- patients with known history of previous orotracheal tumor surgery
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 |
|---|---|---|
| tracheal intubationtracheal intubation with the Airtraq | Procedure or surgery | Tracheal intubation with Airtraq, Tracheal intubation with Fiberscopy |
| Airtraq | Device | Tracheal intubation with Airtraq |
| fiberscope | Device | Tracheal intubation with Fiberscopy |
Primary outcome
Neuromonitoring modifications (modifications appearing on the neuromonitoring)
Time frame: 30 seconds
modifications appearing on the neuromonitoring during the 5 different phases
3 secondary outcomes
time necessary for tracheal intubation
Time frame: 180 seconds
tracheal inlet view (best view during intubation)
Time frame: 10 seconds
number of attempts necessary
Time frame: 180 seconds
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 2 Jan 2018.
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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.
Patrick Schoettker, MD, PD principal investigator
Chief Medical Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tracheal intubation, Airtraq and fiberscope in people with Spinal Injuries, run by University of Lausanne Hospitals 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 4 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 2 Jan 2018. 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?
Neuromonitoring modifications (modifications appearing on the neuromonitoring) (time frame: 30 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2018.