Intubation; DifficultNCT02563301
Videolaryngoscopy in Patients With Cervical Spine Immobilisation
A study testing Laryngoscopy in people with Intubation; Difficult, run by NHS Tayside at 1 site in United Kingdom.
Trial summary
Tracheal intubation is more difficult in patients in whom cervical spine immobilisation is maintained during tracheal intubation. The McGrath Series 5 videolaryngoscope offers a potential solution. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- Laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Nov 2012
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Elective procedure requiring tracheal intubation
- Over 16 years of age
Who cannot join
- Emergency procedure
- Less than 16 years of age
- Unable to consent
- Symptomatic gastro-oesophageal reflux disease
- Evidence of raised intracranial pressure
- Known pharyngeal pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Crossover Trial Comparing the McGrath Series 5 Videolaryngoscope With the Macintosh Laryngoscope in Patients With Cervical Spine Immobilisation
Tracheal intubation is more difficult in patients in whom cervical spine immobilisation is maintained during tracheal intubation. The McGrath Series 5 videolaryngoscope offers a potential solution. The relatively short radius of the blade curvature combined with the internal arrangement of optimal components means that the glottis can be seen without the need for alignment of the oral, pharyngeal and tracheal axes.
The investigators propose that the McGrath Series 5 videolaryngoscope will improve the view of the larynx in patients with limited neck movements, making intubation quicker, easier and possibly safer.
- Conditions
- Intubation; Difficult
- Being tested
- Laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaryngoscopyDevice
After establishing full monitoring, inducing general anaesthesia and ensuring paralysis, laryngoscopy is performed and the patient's trachea is intubated.
| Study group | Role | What they receive |
|---|---|---|
| McGrath Series 5 | Active comparator | Videolaryngoscope used to perform indirect (video) laryngoscopy and tracheal intubation Receives: Device: Laryngoscopy |
| Macintosh | Active comparator | Laryngoscope used to perform direct laryngoscopy and tracheal intubation Receives: Device: Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cormack and Lehane laryngoscopy grade
Measured: 5 minutes
Secondary outcomes (3)
Time to intubation
Measured: 5 minutes
Rate of successful tracheal intubation
Measured: 5 minutes
Incidence of complications
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startAug 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; DifficultStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Tayside
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lynsey Foulds, NHS Tayside
- Investigators
- Lynsey T Foulds, MBChB, Principal investigator, NHS Tayside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563301
- Sponsor's protocol ID
- 2008AN01
- Status last verified
- Sep 2015
- First submitted
- 25 Sep 2015
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Crossover Trial Comparing the McGrath Series 5 Videolaryngoscope With the Macintosh Laryngoscope in Patients With Cervical Spine Immobilisation
- ClinicalTrials.gov ID
- NCT02563301
- Acronym / sponsor ID
- 2008AN01
- Conditions
- Intubation; Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- NHS TaysideOther government
- Study start
- Aug 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Sep 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.
Tracheal intubation is more difficult in patients in whom cervical spine immobilisation is maintained during tracheal intubation. The McGrath Series 5 videolaryngoscope offers a potential solution. The relatively short radius of the blade curvature combined with the internal arrangement of optimal components means that the glottis can be seen without the need for alignment of the oral, pharyngeal and tracheal axes.
The investigators propose that the McGrath Series 5 videolaryngoscope will improve the view of the larynx in patients with limited neck movements, making intubation quicker, easier and possibly safer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McGrath Series 5 | Active comparator | Device: LaryngoscopyVideolaryngoscope used to perform indirect (video) laryngoscopy and tracheal intubation |
| Macintosh | Active comparator | Device: LaryngoscopyLaryngoscope used to perform direct laryngoscopy and tracheal intubation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Elective procedure requiring tracheal intubation
- Over 16 years of age
Key exclusion criteria (6 listed)
- Emergency procedure
- Less than 16 years of age
- Unable to consent
- Symptomatic gastro-oesophageal reflux disease
- Evidence of raised intracranial pressure
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 |
|---|---|---|
| LaryngoscopyAfter establishing full monitoring, inducing general anaesthesia and ensuring paralysis, laryngoscopy is performed and the patient's trachea is intubated. | Device | Macintosh, McGrath Series 5 |
Primary outcome
Cormack and Lehane laryngoscopy grade
Time frame: 5 minutes
3 secondary outcomes
Time to intubation
Time frame: 5 minutes
Rate of successful tracheal intubation
Time frame: 5 minutes
Incidence of complications
Time frame: 5 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 30 Sep 2015.
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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.
Lynsey T Foulds, MBChB principal investigator
NHS Tayside
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngoscopy in people with Intubation; Difficult, run by NHS Tayside at 1 site in United Kingdom.
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 2 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 30 Sep 2015. 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 United Kingdom. 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?
Cormack and Lehane laryngoscopy grade (time frame: 5 minutes). 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 30 Sep 2015.