Tracheal IntubationNCT00633867
Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope
A study testing McGrath and Tracheal intubation using Macintosh Laryngoscope in people with Tracheal Intubation, run by NHS Grampian at 1 site in United Kingdom.
Trial summary
The simplicity of use and intuitive function of the McGrath video-laryngoscope suggests it may have a bigger role than as a back-up to conventional direct laryngoscopy and could possibly be the first-line laryngoscope for situations where difficult intubations are more likely or more hazardous. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- McGrath and Tracheal intubation using Macintosh Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults (18 years and over) scheduled for elective surgery whose anaesthetic plan would normally include oral intubation using a Macintosh laryngoscope blade after induction of general anaesthesia and who have given valid informed consent.
Who cannot join
- Patients requiring special techniques for intubation such as rapid sequence induction
- Adults who have learning difficulties
- Are unconscious or very severely ill
- Have a terminal illness; are in an emergency situation
- Have a mental illness
- Have dementia
- Prisoners
- Those who could be considered to have a particularly dependent relationship with the investigator and other vulnerable groups.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aberdeen Royal Hospitals, NHS Grampian
Aberdeen, UK, AB25 2ZN
About this study
The simplicity of use and intuitive function of the McGrath video-laryngoscope suggests it may have a bigger role than as a back-up to conventional direct laryngoscopy and could possibly be the first-line laryngoscope for situations where difficult intubations are more likely or more hazardous. The incidence of difficult or failed intubation for an individual anaesthetist is related to their experience, decreasing as experience increases. The purpose of this trial is to evaluate the McGrath laryngoscope when used by relatively inexperienced anaesthetists, who are those most likely to encounter difficulties.
The null hypotheses to be tested is that there is no difference between the Macintosh and McGrath laryngoscope in terms of ease and success in intubation.
- Conditions
- Tracheal Intubation
- Being tested
- McGrath, Tracheal intubation using Macintosh Laryngoscope
- Keywords
- Tracheal intubation, Laryngoscopy, videolaryngoscope, McGrath, success, time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGrathDevice
Also called Aircraft Medical McGrath Series 5 Video Laryngoscope
Tracheal intubation, using Mcgrath video-laryngoscope
Tracheal intubation using Macintosh LaryngoscopeDevice
Tracheal intubation using Macintosh Laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Intubation c McGrath videolaryngoscope | Active comparator | Tracheal Intubation using McGrath video-laryngoscope Receives: Device: McGrath |
| Intubation using Macintosh Laryngoscope | Active comparator | Tracheal intubation using Macintosh Laryngoscope Receives: Device: Tracheal intubation using Macintosh Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Time
Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation
Measured: At intubation
Secondary outcomes (7)
Difference in Learning to Use the Scopes
Is there a difference between trainee anaesthetists in learning to use the scopes
Measured: At analysis
Quality of View of the Vocal Cords
Measured: At analysis
Number of Attempts to Secure Successful Intubation
Is there a difference in the number of attempts required to secure successful intubation ?
Measured: At analysis
Incidence of Initial Oesophageal Intubation
Measured: At analysis
Number of Intubations Taking More Than 70 Seconds
Measured: At Analysis
Incidence of Low Arterial Saturation During Intubation
Measured: At analysis
Incidence of Visible Trauma to the Airway
Measured: At analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tracheal 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Grampian
- Sponsor type
- Other government
- Investigators
- william brampton, Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633867
- Sponsor's protocol ID
- 08-so802-4
- Status last verified
- Mar 2008
- First submitted
- 4 Mar 2008
- Last updated
- 2 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Walker L, Brampton W, Halai M, Hoy C, Lee E, Scott I, McLernon DJ. Randomized controlled trial of intubation with the McGrath Series 5 videolaryngoscope by inexperienced anaesthetists. Br J Anaesth. 2009 Sep;103(3):440-5. doi: 10.1093/bja/aep191. Epub 2009 Jul 15.
PubMed 19605408
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope
- ClinicalTrials.gov ID
- NCT00633867
- Acronym / sponsor ID
- 08-so802-4
- Conditions
- Tracheal Intubation
- Keywords
- Tracheal intubation, Laryngoscopy, videolaryngoscope, McGrath, success, time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- NHS GrampianOther government
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Posted 25 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The simplicity of use and intuitive function of the McGrath video-laryngoscope suggests it may have a bigger role than as a back-up to conventional direct laryngoscopy and could possibly be the first-line laryngoscope for situations where difficult intubations are more likely or more hazardous. The incidence of difficult or failed intubation for an individual anaesthetist is related to their experience, decreasing as experience increases. The purpose of this trial is to evaluate the McGrath laryngoscope when used by relatively inexperienced anaesthetists, who are those most likely to encounter difficulties.
The null hypotheses to be tested is that there is no difference between the Macintosh and McGrath laryngoscope in terms of ease and success in intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubation c McGrath videolaryngoscope | Active comparator | Device: McGrathTracheal Intubation using McGrath video-laryngoscope |
| Intubation using Macintosh Laryngoscope | Active comparator | Device: Tracheal intubation using Macintosh LaryngoscopeTracheal intubation using Macintosh Laryngoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (18 years and over) scheduled for elective surgery whose anaesthetic plan would normally include oral intubation using a Macintosh laryngoscope blade after induction of general anaesthesia and who have given valid informed consent.
Key exclusion criteria (8 listed)
- Patients requiring special techniques for intubation such as rapid sequence induction
- Adults who have learning difficulties
- Are unconscious or very severely ill
- Have a terminal illness; are in an emergency situation
- Have a mental illness
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 |
|---|---|---|
| McGrathAlso: Aircraft Medical McGrath Series 5 Video LaryngoscopeTracheal intubation, using Mcgrath video-laryngoscope | Device | Intubation c McGrath videolaryngoscope |
| Tracheal intubation using Macintosh LaryngoscopeTracheal intubation using Macintosh Laryngoscope | Device | Intubation using Macintosh Laryngoscope |
Primary outcome
Intubation Time
Time frame: At intubation
Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation
7 secondary outcomes
Difference in Learning to Use the Scopes
Time frame: At analysis
Quality of View of the Vocal Cords
Time frame: At analysis
Number of Attempts to Secure Successful Intubation
Time frame: At analysis
Incidence of Initial Oesophageal Intubation
Time frame: At analysis
Number of Intubations Taking More Than 70 Seconds
Time frame: At Analysis
Incidence of Low Arterial Saturation During Intubation
Time frame: At analysis
Incidence of Visible Trauma to the Airway
Time frame: At analysis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19605408Walker L, Brampton W, Halai M, Hoy C, Lee E, Scott I, McLernon DJ. Randomized controlled trial of intubation with the McGrath Series 5 videolaryngoscope by inexperienced anaesthetists. Br J Anaesth. 2009 Sep;103(3):440-5. doi: 10.1093/bja/aep191. Epub 2009 Jul 15.
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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.
william brampton principal investigator
NHS Grampian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McGrath and Tracheal intubation using Macintosh Laryngoscope in people with Tracheal Intubation, run by NHS Grampian 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 1 inclusion and 8 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 Aug 2011. 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?
Yes. Results are posted in the registry (first posted 25 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intubation Time (time frame: At intubation). 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 NCT00633867, which also lists 1 linked publication.
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 Aug 2011.