Thoracic InjuriesMacGrathDESNCT03710096
Comparison of McGrath and Macintosh Laryngoscopes for Insertion of a Double Lumen Tube by Residents
A study testing macGrath and Macintosh's in people with Thoracic Injuries, run by University Hospital, Lille at 1 site in France.
Trial summary
The insertion of double lumen tube is difficult even more if it is a resident with no experience. we think that using videolaryngoscopes for novice ones would facilitate insertion of double lumen tube thanks to the visualization on a LCD screen of the laryngeal structure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Injuries
- What is being tested?
- macGrath and Macintosh's
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2018to 8 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thoracic Surgery
- Insertion of double lumen tube
Who cannot join
- Emergency surgery
- Risk of inhalation
- Person unable to consent
- Persons deprived of liberty, under guardianship or trusteeship
- Pregnant or lactating woman
- Allergy to Tracrium, Propofol, Sufentanil
Trial locations and contacts
1 site in 1 country.
About this study
The insertion of double lumen tube is difficult even more if it is a resident with no experience. we think that using videolaryngoscopes for novice ones would facilitate insertion of double lumen tube thanks to the visualization on a LCD screen of the laryngeal structure.
- Conditions
- Thoracic Injuries
- Being tested
- macGrath, Macintosh's
- Keywords
- Mac Grath, Double lumen tube
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
macGrathDevice
in the mac grath group we use the videolaryngoscope macGrath as first-line for the insertion of double lumen tube
Macintosh'sDevice
in the macintosh group we use the laryngoscope with Macintosh's blade as first-line for the insertion of double lumen tube
| Study group | Role | What they receive |
|---|---|---|
| Mac grath group | Experimental | Not described Receives: Device: macGrath |
| Macintosh Group | Active comparator | Not described Receives: Device: Macintosh's |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of success of intubation in both groups at the first attempt
the success is defined as a correct implementation of the probe endotracheal in double light by an internal of anesthesia in the 1st attempt.
Measured: Baseline: one session
Secondary outcomes (5)
Individual Determination of Cormack Stage
scoring system for the grading of direct laryngoscopy in case of tracheal intubation is difficult
Measured: Baseline: one session
Rate of good positioning of double lumen tube confirmed by fibroscopy
Measured: Baseline: one session
The rate of patients with an increase in systolic blood pressure of more than 20% compared to the measurement before insertion of the probe
Measured: Baseline: one session
Intubation time
Measured: Baseline: one session
The rate of patients with pharyngeal pains upon awakening
Measured: Baseline: one session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start4 Nov 2018
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Desbordes, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710096
- Sponsor's protocol ID
- 2017_65
- Other IDs
- 2018-A00789-46
- Acronym
- MacGrathDES
- Status last verified
- Nov 2022
- First submitted
- 10 Oct 2018
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of McGrath and Macintosh Laryngoscopes for Insertion of a Double Lumen Tube by Residents
- ClinicalTrials.gov ID
- NCT03710096
- Acronym / sponsor ID
- MacGrathDES / 2017_65
- Conditions
- Thoracic Injuries
- Keywords
- Mac Grath, Double lumen tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 4 Nov 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 17 Oct 2018 (actual)
- 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 insertion of double lumen tube is difficult even more if it is a resident with no experience. we think that using videolaryngoscopes for novice ones would facilitate insertion of double lumen tube thanks to the visualization on a LCD screen of the laryngeal structure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mac grath group | Experimental | Device: macGrath |
| Macintosh Group | Active comparator | Device: Macintosh's |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Thoracic Surgery
- Insertion of double lumen tube
Key exclusion criteria (6 listed)
- Emergency surgery
- Risk of inhalation
- Person unable to consent
- Persons deprived of liberty, under guardianship or trusteeship
- Pregnant or lactating woman
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 |
|---|---|---|
| macGrathin the mac grath group we use the videolaryngoscope macGrath as first-line for the insertion of double lumen tube | Device | Mac grath group |
| Macintosh'sin the macintosh group we use the laryngoscope with Macintosh's blade as first-line for the insertion of double lumen tube | Device | Macintosh Group |
Primary outcome
Rate of success of intubation in both groups at the first attempt
Time frame: Baseline: one session
the success is defined as a correct implementation of the probe endotracheal in double light by an internal of anesthesia in the 1st attempt.
5 secondary outcomes
Individual Determination of Cormack Stage
Time frame: Baseline: one session
Rate of good positioning of double lumen tube confirmed by fibroscopy
Time frame: Baseline: one session
The rate of patients with an increase in systolic blood pressure of more than 20% compared to the measurement before insertion of the probe
Time frame: Baseline: one session
Intubation time
Time frame: Baseline: one session
The rate of patients with pharyngeal pains upon awakening
Time frame: Baseline: one session
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 4 Nov 2022.
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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.
Jacques Desbordes, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing macGrath and Macintosh's in people with Thoracic Injuries, run by University Hospital, Lille at 1 site in France.
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 4 Nov 2022. 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 France. 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?
Rate of success of intubation in both groups at the first attempt (time frame: Baseline: one session). 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 4 Nov 2022.