Pulmonary Aspiration of Gastric ContentsLARANCT04794764
Videolaryngoscopy Compared to Direct Laryngoscopy
A study testing McGrath Mac and Macintosh Laryngoscope in people with Pulmonary Aspiration of Gastric Contents, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Videolaryngoscope (Macintosh-type blade) compared with direct laryngoscopy for rapid sequence intubation in the operating room Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Aspiration of Gastric Contents
- What is being tested?
- McGrath Mac and Macintosh Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jul 2021to 31 Aug 2023
- 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
- Age ≥ 18 Years
- capacity to consent
- Present written informed consent of the research participant
Who cannot join
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- Difficult Airway / Defined Indications for awake intubation
- Participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
Mainz, Rhineland-Palatinate, D55131
About this study
Official title: Evaluation of Videolaryngoscopy (McGrath Mac) Compared to Direct Laryngoscopy for Rapid Sequence Intubation in Operating Room
Videolaryngoscope (Macintosh-type blade) compared with direct laryngoscopy for rapid sequence intubation in the operating room
Read the detailed description
Video laryngoscopy (VL) is a etablished method of achieving tracheal intubation and there is evidence to show that visualisation of larynx can be improved using VL in failed tracheal Intubation (NAP 4 Report). VL has been shown to improve first attempt success compared to direct laryngoscopy in many clinical settings including intensive care unit (ICU) and emergency department (ED). This is a proposed comparison study of a VL, use in patients with a high risk for pulmonary Aspiration and requiring tracheal Intubation. An national, multi-center, prospective randomized comparative trial is proposed testing the superiority of oral tracheal intubation with the McGrath® MAC versus conventional laryngoscope in adult patients under general anesthesia.
- Conditions
- Pulmonary Aspiration of Gastric Contents
- Being tested
- McGrath Mac, Macintosh Laryngoscope
- Keywords
- Airway Management, Videolaryngoscopy, Adverse Events
- Medical subject headings
- Respiratory Aspiration of Gastric Contents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGrath MacDevice
in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.
Macintosh LaryngoscopeDevice
in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.
| Study group | Role | What they receive |
|---|---|---|
| McGrath MAC | Experimental | First pass success rate using the McGrath Mac Receives: Device: McGrath Mac |
| Macintosh Laryngoscope | Experimental | First pass success rate using the Macintosh laryngoscope Receives: Device: Macintosh Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
First pass Intubation success rate
successful tracheal intubation at the first attempt, compared to more than one attempt
Measured: at intubation in 60 seconds
Secondary outcomes (6)
Time to ventilation
From Insertion of the blase into the mouth until first ventilation
Measured: at intubation in 120 seconds
Cormack and Lehane Classification
after insert the device the user describe the glottis visualisation
Measured: < 120 seconds
Overall success rate
after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask)
Measured: < 120 seconds
Intubation difficult score
Based on parameters known to be associated with difficult intubation (0=easy intubation to 5=difficult intubation
Measured: < 120 seconds
adverse events
sore throat
Measured: after 24 hours
complications
mucosal injury
Measured: < 120 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start24 Jul 2021
- Primary completion1 Jul 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Aspiration of Gastric ContentsStudies 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
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Krankenhaus der Borromaerinnen Trier, University Medical Center Freiburg, BundeswehrZentralkrankenhaus Koblenz, Krankenhaus Hetzelstift
- Responsible party
- Principal investigator, Marc Kriege, MD, Johannes Gutenberg University Mainz
- Investigators
- Marc Kriege, MD, PhD, Principal investigator, University JG, Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794764
- Sponsor's protocol ID
- JohannesGUV
- Acronym
- LARA
- Status last verified
- Jan 2024
- First submitted
- 9 Mar 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kriege M, Lang P, Lang C, Pirlich N, Griemert EV, Heid F, Wittenmeier E, Schmidtmann I, Schmidbauer W, Janig C, Jungbecker J, Kunitz O, Strate M, Schmutz A. Anaesthesia protocol evaluation of the videolaryngoscopy with the McGrath MAC and direct laryngoscopy for tracheal intubation in 1000 patients undergoing rapid sequence induction: the randomised multicentre LARA trial study protocol. BMJ Open. 2021 Oct 6;11(10):e052977. doi: 10.1136/bmjopen-2021-052977.
PubMed 34615684
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Videolaryngoscopy (McGrath Mac) Compared to Direct Laryngoscopy for Rapid Sequence Intubation in Operating Room
- ClinicalTrials.gov ID
- NCT04794764
- Acronym / sponsor ID
- LARA / JohannesGUV
- Conditions
- Pulmonary Aspiration of Gastric Contents
- Keywords
- Airway Management, Videolaryngoscopy, Adverse Events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Krankenhaus der Borromaerinnen Trier, University Medical Center Freiburg, BundeswehrZentralkrankenhaus Koblenz, Krankenhaus Hetzelstift
- Study start
- 24 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 12 Mar 2021 (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.
Videolaryngoscope (Macintosh-type blade) compared with direct laryngoscopy for rapid sequence intubation in the operating room
Detailed description
Video laryngoscopy (VL) is a etablished method of achieving tracheal intubation and there is evidence to show that visualisation of larynx can be improved using VL in failed tracheal Intubation (NAP 4 Report). VL has been shown to improve first attempt success compared to direct laryngoscopy in many clinical settings including intensive care unit (ICU) and emergency department (ED). This is a proposed comparison study of a VL, use in patients with a high risk for pulmonary Aspiration and requiring tracheal Intubation. An national, multi-center, prospective randomized comparative trial is proposed testing the superiority of oral tracheal intubation with the McGrath® MAC versus conventional laryngoscope in adult patients under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McGrath MAC | Experimental | Device: McGrath MacFirst pass success rate using the McGrath Mac |
| Macintosh Laryngoscope | Experimental | Device: Macintosh LaryngoscopeFirst pass success rate using the Macintosh laryngoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 Years
- capacity to consent
- Present written informed consent of the research participant
Key exclusion criteria (6 listed)
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- Difficult Airway / Defined Indications for awake 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 |
|---|---|---|
| McGrath Macin a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea. | Device | McGrath MAC |
| Macintosh Laryngoscopein a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea. | Device | Macintosh Laryngoscope |
Primary outcome
First pass Intubation success rate
Time frame: at intubation in 60 seconds
successful tracheal intubation at the first attempt, compared to more than one attempt
6 secondary outcomes
Time to ventilation
Time frame: at intubation in 120 seconds
Cormack and Lehane Classification
Time frame: < 120 seconds
Overall success rate
Time frame: < 120 seconds
Intubation difficult score
Time frame: < 120 seconds
adverse events
Time frame: after 24 hours
complications
Time frame: < 120 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 5 Jan 2024.
- Derived from this study: PubMed 34615684Kriege M, Lang P, Lang C, Pirlich N, Griemert EV, Heid F, Wittenmeier E, Schmidtmann I, Schmidbauer W, Janig C, Jungbecker J, Kunitz O, Strate M, Schmutz A. Anaesthesia protocol evaluation of the videolaryngoscopy with the McGrath MAC and direct laryngoscopy for tracheal intubation in 1000 patients undergoing rapid sequence induction: the randomised multicentre LARA trial study protocol. BMJ Open. 2021 Oct 6;11(10):e052977. doi: 10.1136/bmjopen-2021-052977.
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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.
Marc Kriege, MD, PhD principal investigator
University JG, Mainz
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 Mac and Macintosh Laryngoscope in people with Pulmonary Aspiration of Gastric Contents, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 5 Jan 2024. 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 Germany. 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?
First pass Intubation success rate (time frame: at intubation in 60 seconds). 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 NCT04794764, 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 5 Jan 2024; AzTrials last refreshed its copy on 28 Oct 2026.