Patients With One or More Predictors of Difficult AirwayNCT01976546
Intubation With McGrath Video Laryngoscope and Boedeker Intubation Foreceps in a Population of Patients With Predictors of Difficult Airway
An observational study of Patients With One or More Predictors of Difficult Airway, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Tracheal intubation with videolaryngoscopes have been widely studied, and is now often used in the management of difficult airways. Videolaryngoscopes with angulated blades can improve laryngeal view, however this does not always match with a higher intubation succes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With One or More Predictors of Difficult Airway
- What is being tested?
- Intubation with mcgrath videolaryngoscope and Boedeker intubation foreceps
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with one or more predictors of difficult airway
Who may be able to join
- patients scheduled for elective surgery
- age over 18 or more
- planned intubation with mcgrath videolaryngoscope
- informed conscent obtained
- patients are
- patients shall be able to read and understand Danish
Who cannot join
- Patients planned to awake intubation
- stridor
- hypoxia defined by saturation under 90% without oxygen supply
- patients with oxygentreatment at home
- patients that need a wired tube
- patients that need a preshaped tube
- patients that need crash induction
- use of gastric tube
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Anaesthesia, Centre of Head and Orthopedics 4231, Rigshospitalet
Copenhagen, 2100
About this study
Official title: Intubation With McGrath Video Laryngoscope and Boedeker Intubation Foreceps in a Population of Patients With Predictors of Difficult Airway, an Observational Pilot Study
Tracheal intubation with videolaryngoscopes have been widely studied, and is now often used in the management of difficult airways.
Videolaryngoscopes with angulated blades can improve laryngeal view, however this does not always match with a higher intubation succes. To adress this matter the aim of this study is gathering experience with intubation with mcgrath videolaryngoscope and a blade-shape intubation foreceps (Boedeker intubation foreceps, Karl Storz, Germany).
The hypothesis is that intubation with this combination is easy and can be a good alternative when using the McGrath videolaryngoscope in patients with predictors of difficult airway.
- Being tested
- Intubation with mcgrath videolaryngoscope and Boedeker intubation foreceps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation with mcgrath videolaryngoscope and Boedeker intubation forecepsDevice
Also called Aircraft Medical McGRATH series 5 videolaryngoscope, Karl Storz Boedeker intubation foreceps
Patients will be intubated with the Mcgrath videolaryngoscope and a tracheal tube placed by Boedeker intubation foreceps
| Study group | Role | What they receive |
|---|---|---|
| airway | Patients with one or more predictors of diffucult airway Receives: Device: Intubation with mcgrath videolaryngoscope and Boedeker intubation foreceps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubation
Measured: within one day
Secondary outcomes (6)
Sore throat
Measured: within 2 days
succesful intubation
Measured: within one day
Damage on teeth
Measured: 2 days
Intubation difficulty
Intubation difficulty scale
Measured: within one day
Intubation conditions
a.m fuchs-buder
Measured: within one day
Intubation attempts
Measured: within one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With One or More Predictors of Difficult AirwayStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Strøm, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Camilla Strøm, M.D, Principal investigator, Dept. of anaesthesia, centre of head and orthopedics, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976546
- Sponsor's protocol ID
- LP-CS-13
- Status last verified
- Oct 2014
- First submitted
- 29 Oct 2013
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubation With McGrath Video Laryngoscope and Boedeker Intubation Foreceps in a Population of Patients With Predictors of Difficult Airway, an Observational Pilot Study
- ClinicalTrials.gov ID
- NCT01976546
- Acronym / sponsor ID
- LP-CS-13
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Nov 2013 (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.
Tracheal intubation with videolaryngoscopes have been widely studied, and is now often used in the management of difficult airways.
Videolaryngoscopes with angulated blades can improve laryngeal view, however this does not always match with a higher intubation succes. To adress this matter the aim of this study is gathering experience with intubation with mcgrath videolaryngoscope and a blade-shape intubation foreceps (Boedeker intubation foreceps, Karl Storz, Germany).
The hypothesis is that intubation with this combination is easy and can be a good alternative when using the McGrath videolaryngoscope in patients with predictors of difficult airway.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| airway | – | Device: Intubation with mcgrath videolaryngoscope and Boedeker intubation forecepsPatients with one or more predictors of diffucult airway |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with one or more predictors of difficult airway
Key inclusion criteria (6 listed)
- patients scheduled for elective surgery
- age over 18 or more
- planned intubation with mcgrath videolaryngoscope
- informed conscent obtained
- patients are
Key exclusion criteria (8 listed)
- Patients planned to awake intubation
- stridor
- hypoxia defined by saturation under 90% without oxygen supply
- patients with oxygentreatment at home
- patients that need a wired tube
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 |
|---|---|---|
| Intubation with mcgrath videolaryngoscope and Boedeker intubation forecepsAlso: Aircraft Medical McGRATH series 5 videolaryngoscope, Karl Storz Boedeker intubation forecepsPatients will be intubated with the Mcgrath videolaryngoscope and a tracheal tube placed by Boedeker intubation foreceps | Device | airway |
Primary outcome
Time to intubation
Time frame: within one day
6 secondary outcomes
Sore throat
Time frame: within 2 days
succesful intubation
Time frame: within one day
Damage on teeth
Time frame: 2 days
Intubation difficulty
Time frame: within one day
Intubation conditions
Time frame: within one day
Intubation attempts
Time frame: within one day
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 27 Oct 2014.
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.
Camilla Strøm, M.D principal investigator
Dept. of anaesthesia, centre of head and orthopedics, Rigshospitalet, Denmark
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 Patients With One or More Predictors of Difficult Airway, run by Copenhagen University Hospital, Rigshospitalet 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 6 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 27 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 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?
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?
Time to intubation (time frame: within one day). 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 27 Oct 2014.