Airway MorbidityNCT02035449
Video Laryngoscopy in Pre-hospital Critical Care
An observational study of Airway Morbidity and Airway Disease, run by University of Aarhus at 1 site in Denmark.
Trial summary
Difficult conditions and critically ill and injured patients may complicate endotracheal intubation in the pre-hospital setting. The incidence of complications increase when two or more endotracheal intubation attempts are needed. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Airway Morbidity, Airway Disease, Respiratory Insufficiency
- What is being tested?
- McGrath MAC
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2013to Dec 2014
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in the Central Region of Denmark where the anaesthesiologists on the participating pre-hospital critical care teams attempt prehospital endotracheal intubation.
Who may be able to join
- Patients where the anaesthesiologists on the participating pre-hospital critical care teams attempt prehospital endotracheal intubation.
Who cannot join
- Patients< 15 years of age
Trial locations and contacts
1 site in 1 country.
Leif Rognaas, Doctor contact
Denmark1 site, 1 recruiting
- Recruiting
Pre-hospital Medical Services, Central Denmark Region
Aarhus, 8200
Mads P Vandborg, Doctor, +4578445224, madvan@rm.dk
Leif Rognaas, Doctor, leifrogn@rm.dk
About this study
Difficult conditions and critically ill and injured patients may complicate endotracheal intubation in the pre-hospital setting. The incidence of complications increase when two or more endotracheal intubation attempts are needed.
The aim of this study is to estimate the incidence of difficult pre-hospital endotracheal intubation after the introduction of the McGrath MAC Video laryngoscope as the primary airway device for pre-hospital endotracheal intubation.
Read more
Hypothesis:
- In our pre-hospital critical care teams, staffed with experienced anaesthesiologists, the rate of difficult PHETI (defined as more than one intubation attempt needed to secure a patent airway) is lower than 10 %, when using the McGrath MAC VL as primary choice in pre-hospital intubations.
- Being tested
- McGrath MAC
- Keywords
- Video laryngoscope, Pre-hospital, Endotracheal intubation, Difficult endotracheal intubation, Pre hospital Critical care, McGrath MAC, Airway device
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGrath MACDevice
McGrath MAC is a videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| McGrath MAC | McGrath MAC is a videolaryngscope Receives: Device: McGrath MAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of difficult pre-hospital endotracheal intubation
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway MorbidityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mads P Vandborg, Doctor, Principal investigator, Pre-hospital Medical Services, Central Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035449
- Sponsor's protocol ID
- McGrath MAC 1
- Status last verified
- Dec 2013
- First submitted
- 10 Jan 2014
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Laryngoscopy in Pre-hospital Critical Care
- ClinicalTrials.gov ID
- NCT02035449
- Acronym / sponsor ID
- McGrath MAC 1
- Keywords
- Video laryngoscope, Pre-hospital, Endotracheal intubation, Difficult endotracheal intubation, Pre hospital Critical care, McGrath MAC, Airway device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 14 Jan 2014 (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.
Difficult conditions and critically ill and injured patients may complicate endotracheal intubation in the pre-hospital setting. The incidence of complications increase when two or more endotracheal intubation attempts are needed.
The aim of this study is to estimate the incidence of difficult pre-hospital endotracheal intubation after the introduction of the McGrath MAC Video laryngoscope as the primary airway device for pre-hospital endotracheal intubation.
Hypothesis:
- In our pre-hospital critical care teams, staffed with experienced anaesthesiologists, the rate of difficult PHETI (defined as more than one intubation attempt needed to secure a patent airway) is lower than 10 %, when using the McGrath MAC VL as primary choice in pre-hospital intubations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| McGrath MAC | – | Device: McGrath MACMcGrath MAC is a videolaryngscope |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in the Central Region of Denmark where the anaesthesiologists on the participating pre-hospital critical care teams attempt prehospital endotracheal intubation.
Key inclusion criteria (1 listed)
- Patients where the anaesthesiologists on the participating pre-hospital critical care teams attempt prehospital endotracheal intubation.
Key exclusion criteria (1 listed)
- Patients< 15 years of age
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 MACMcGrath MAC is a videolaryngoscope | Device | McGrath MAC |
Primary outcome
The incidence of difficult pre-hospital endotracheal intubation
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 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.
Leif Rognaas, Doctor contact
Mads P Vandborg, Doctor principal investigator
Pre-hospital Medical Services, Central Denmark Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Morbidity and Airway Disease, run by University of Aarhus at 1 site in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 14 Jan 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mads P Vandborg, Doctor (+45 78445224, madvan@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of difficult pre-hospital endotracheal intubation (time frame: One year). 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 14 Jan 2014.