Tracheal IntubationNCT01100957
Evaluation of the Single Use Flexible Optical Scope Versus Multiple Use Flexible Optical Scopes for Intubation
A study testing tracheal intubation with a single use flexible videoscope in people with Tracheal Intubation and Difficult Airway, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The study is in two parts Part one of the study describes the use of the new single-use flexible video-scope for intubation of patients with predicted normal airways. Part two compares the performance of the single-use flexible video-scope with that of a conventional flexible video-scope for awake intubation of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tracheal Intubation, Difficult Airway
- What is being tested?
- tracheal intubation with a single use flexible videoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Dec 2010
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study part 1:
- Patients scheduled for tracheal intubation and predicted to have a normal airway
- ASA class I, II or III
- >18 years
- Study part 2:
- Adult patients scheduled for tracheal intubation and predicted to have a difficult airway
- ASA class I, II or III
- >18 years
Who cannot join
- Study part 1:
- Massive bleeding from the mouth
- Previously abandoned flexible optical intubation
- Study part 2:
- Massive bleeding from the mouth
- Previously abandoned flexible optical intubation
- Patients with audible stridor
- Patients with dyspnea
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
Copenhagen, 2100
About this study
Official title: Evaluation and Comparison of the New Single Use Ambu aScope With Olympus BF 160 Multiple Use Scope for Securing the Airway of the Anaesthetised/Awake Patients' Normal or Difficult Airway
The study is in two parts
Part one of the study describes the use of the new single-use flexible video-scope for intubation of patients with predicted normal airways.
Part two compares the performance of the single-use flexible video-scope with that of a conventional flexible video-scope for awake intubation of patients with predicted difficult airways.
The hypothesis is that the new single-use flexible video-scope for intubation performs as well as the traditional scope.
- Conditions
- Tracheal Intubation, Difficult Airway
- Being tested
- tracheal intubation with a single use flexible videoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tracheal intubation with a single use flexible videoscopeProcedure or surgery
tracheal intubation with a single use flexible videoscope
| Study group | Role | What they receive |
|---|---|---|
| Conventional flexible videoscope for intubation | Active comparator | Not described Receives: Procedure: tracheal intubation with a single use flexible videoscope |
| Single-patient flexible endoscope | Experimental | Single-patient flexible video-endoscope used for tracheal intubation in this intervention-arm Receives: Procedure: tracheal intubation with a single use flexible videoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
time for completion of intubation
This, the time for intubation, is measured immediately during the intubation, on the day that the specific patient participates in the study
Measured: September 2010
Secondary outcomes (7)
time for preparing and cleaning the endoscopes
this is measured in the hour before and after the intubation
Measured: september 2010
number of intubation attempts
measured during the intubation
Measured: september 2010
success rate of endotracheal intubation
measured during the intubation
Measured: september 2010
total time for the intubation-procedure inclusive the time for distributing local analgesics
measured during the intubation
Measured: september 2010
Quality of the image from the videoscope
Observed immediately before, and during, the intubation
Measured: september 2010
Evaluation of the insertion cord of the flexible scope
measured during the intubation
Measured: september 2010
Evaluation of the working-/-injection-channel
measured during the intubation
Measured: september 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionDec 2010
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Seltz Kristensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Michael S Kristensen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100957
- Sponsor's protocol ID
- aScope-1+2 a
- Other IDs
- H-A-2009-022
- Status last verified
- Mar 2010
- First submitted
- 25 Mar 2010
- Last updated
- 24 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Comparison of the New Single Use Ambu aScope With Olympus BF 160 Multiple Use Scope for Securing the Airway of the Anaesthetised/Awake Patients' Normal or Difficult Airway
- ClinicalTrials.gov ID
- NCT01100957
- Acronym / sponsor ID
- aScope-1+2 a
- Conditions
- Tracheal Intubation, Difficult Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Apr 2010 (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.
The study is in two parts
Part one of the study describes the use of the new single-use flexible video-scope for intubation of patients with predicted normal airways.
Part two compares the performance of the single-use flexible video-scope with that of a conventional flexible video-scope for awake intubation of patients with predicted difficult airways.
The hypothesis is that the new single-use flexible video-scope for intubation performs as well as the traditional scope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional flexible videoscope for intubation | Active comparator | Procedure: tracheal intubation with a single use flexible videoscope |
| Single-patient flexible endoscope | Experimental | Procedure: tracheal intubation with a single use flexible videoscopeSingle-patient flexible video-endoscope used for tracheal intubation in this intervention-arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Study part 1:
- Study part 2:
Key exclusion criteria (8 listed)
- Study part 1:
- Study part 2:
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 |
|---|---|---|
| tracheal intubation with a single use flexible videoscopetracheal intubation with a single use flexible videoscope | Procedure or surgery | Conventional flexible videoscope for intubation, Single-patient flexible endoscope |
Primary outcome
time for completion of intubation
Time frame: September 2010
This, the time for intubation, is measured immediately during the intubation, on the day that the specific patient participates in the study
7 secondary outcomes
time for preparing and cleaning the endoscopes
Time frame: september 2010
number of intubation attempts
Time frame: september 2010
success rate of endotracheal intubation
Time frame: september 2010
total time for the intubation-procedure inclusive the time for distributing local analgesics
Time frame: september 2010
Quality of the image from the videoscope
Time frame: september 2010
Evaluation of the insertion cord of the flexible scope
Time frame: september 2010
Evaluation of the working-/-injection-channel
Time frame: september 2010
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 24 Aug 2011.
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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.
Michael S Kristensen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tracheal intubation with a single use flexible videoscope in people with Tracheal Intubation and 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 8 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 24 Aug 2011. 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 for completion of intubation (time frame: September 2010). 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 24 Aug 2011.