Tracheal IntubationNCT01516164
A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope
A study testing Laryngoscopy in people with Tracheal Intubation, run by NHS Tayside at 1 site in United Kingdom.
Trial summary
Videolaryngoscopes offer the potential to make tracheal intubation easier for the anaesthetist and less traumatic for the patient. This study aims to compare the intubation difficulty scores (a validated scoring system for ease of intubation) using the McGrath MAC as a videolaryngoscope, the McGrath MAC only as a… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- Laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Feb 2014
- 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
- Elective procedure requiring oral tracheal tube intubation
- Over 16 years of age
- Airway assessment suggests to the anaesthetist that a standard MacIntosh laryngoscope approach to intubation would be appropriate.
Who cannot join
- Emergency procedure
- Less than 16 years of age
- Unable to consent
- Requiring Rapid Sequence Induction (a specialised anaesthetic induction technique)
- Predicted difficult intubation
- Not suitable for the standardised induction technique
Trial locations and contacts
1 site in 1 country.
About this study
Videolaryngoscopes offer the potential to make tracheal intubation easier for the anaesthetist and less traumatic for the patient. This study aims to compare the intubation difficulty scores (a validated scoring system for ease of intubation) using the McGrath MAC as a videolaryngoscope, the McGrath MAC only as a direct laryngoscope (without video screen) and the MacIntosh laryngoscopes.
- Conditions
- Tracheal Intubation
- Being tested
- Laryngoscopy
- Keywords
- Laryngoscopy, Videolaryngoscopy, Ease of Intubation
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 intubated.
| Study group | Role | What they receive |
|---|---|---|
| MacIntosh | Active comparator | Not described Receives: Device: Laryngoscopy |
| McGrath MAC direct | Active comparator | Not described Receives: Device: Laryngoscopy |
| McGrath MAC indirect | Active comparator | Not described Receives: Device: Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Difficulty Score
The Intubation Difficulty Scale (IDS) is a numerical score based on seven parameters. The scoring of each parameter represents a divergence from an 'ideal' condition and the total score represents a sum divergence from a zero difficulty ideal intubation. The seven parameters are number of supplementary attempts, number of supplementary operators, number and type of alternative techniques used, laryngoscopic grade, subjective lifting force, the use of external laryngeal manipulation and mobility or position of the vocal cords.
Measured: 5 minutes
Secondary outcomes (6)
Time to intubation
Measured: 5 minutes
Number and types of alternative techniques used
Measured: 5 minutes
Perception of force used
Measured: 5 minutes
Complications
Measured: 5 minutes
Ease of intubation
Measured: 5 minutes
Failure to intubate
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 posted24 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Tayside
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Claire Wallace, NHS Tayside
- Investigators
- Claire D Wallace, MBChB, Principal investigator, NHS Tayside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516164
- Sponsor's protocol ID
- 2011AN04
- Status last verified
- Oct 2014
- First submitted
- 19 Jan 2012
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope
- ClinicalTrials.gov ID
- NCT01516164
- Acronym / sponsor ID
- 2011AN04
- Conditions
- Tracheal Intubation
- Keywords
- Laryngoscopy, Videolaryngoscopy, Ease of Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- NHS TaysideOther government
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 24 Jan 2012 (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.
Videolaryngoscopes offer the potential to make tracheal intubation easier for the anaesthetist and less traumatic for the patient. This study aims to compare the intubation difficulty scores (a validated scoring system for ease of intubation) using the McGrath MAC as a videolaryngoscope, the McGrath MAC only as a direct laryngoscope (without video screen) and the MacIntosh laryngoscopes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MacIntosh | Active comparator | Device: Laryngoscopy |
| McGrath MAC direct | Active comparator | Device: Laryngoscopy |
| McGrath MAC indirect | Active comparator | Device: Laryngoscopy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Elective procedure requiring oral tracheal tube intubation
- Over 16 years of age
- Airway assessment suggests to the anaesthetist that a standard MacIntosh laryngoscope approach to intubation would be appropriate.
Key exclusion criteria (6 listed)
- Emergency procedure
- Less than 16 years of age
- Unable to consent
- Requiring Rapid Sequence Induction (a specialised anaesthetic induction technique)
- Predicted difficult intubation
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 intubated. | Device | MacIntosh, McGrath MAC direct, McGrath MAC indirect |
Primary outcome
Intubation Difficulty Score
Time frame: 5 minutes
The Intubation Difficulty Scale (IDS) is a numerical score based on seven parameters. The scoring of each parameter represents a divergence from an 'ideal' condition and the total score represents a sum divergence from a zero difficulty ideal intubation. The seven parameters are number of supplementary attempts, number of supplementary operators, number and type of alternative techniques used, laryngoscopic grade, subjective lifting force, the use of external laryngeal manipulation and mobility or position of the vocal cords.
6 secondary outcomes
Time to intubation
Time frame: 5 minutes
Number and types of alternative techniques used
Time frame: 5 minutes
Perception of force used
Time frame: 5 minutes
Complications
Time frame: 5 minutes
Ease of intubation
Time frame: 5 minutes
Failure to intubate
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 6 Oct 2014.
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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.
Claire D Wallace, 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 Tracheal Intubation, 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 3 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 6 Oct 2014. 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?
Intubation Difficulty Score (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 6 Oct 2014.