Intubation IntraesophagealNCT01080118
Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices
A study testing Airtraq in people with Intubation Intraesophageal, run by Northwestern University at 1 site in United States.
Trial summary
The use of the video laryngoscope to teach laryngoscopy will improve the performance of tracheal intubation done by novices because it will allow a shared view of the airway leading to a better feedback from the trainer to the trainee. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intubation Intraesophageal
- What is being tested?
- Airtraq
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical student or intern rotating through the anesthesiology department
- Age 18 -75 years of age
- ASA PS I, II
- Procedure that will require General anesthesia with tracheal intubation
Who cannot join
- Previous attempts of laryngoscopy in humans
- Subject who refuses participation
- Patients:
- Age < 18 years old or greater than 75 years of age
- Patient or student who refuses participation
- ASA Physical status class III or greater
Show all 14Show fewer
- History of lung disease
- History of obstructive sleep apnea
- History of difficult intubation
- Evidence of possible difficult airway (Mallampati Class >2, TMH distance <6 cm, mouth opening <4 cm and limited neck mobility)
- Unanticipated difficult laryngoscopy (defined by inability of the attending anesthesiology to intubate after 2 attempts)
- Patients at risk for aspiration
- Patients with BMI greater than 35
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: A Clinical Trial on the Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices
The use of the video laryngoscope to teach laryngoscopy will improve the performance of tracheal intubation done by novices because it will allow a shared view of the airway leading to a better feedback from the trainer to the trainee.
Read the detailed description
A group of 30 fourth year medical students and interns rotating through the department of anesthesiology will be studied. Firstly, a standard lecture will be provided in which the description and importance of laryngoscopy and tracheal intubation will be explained. This will include descriptions of anatomy, relevant equipment and technique of tracheal intubation. Following the lecture , the students will be randomly allocated using sealed envelopes into two groups : a control group ( taught with a standard Macintosh Laryngoscope ) and a study group ( taught with the Airtraq video laryngoscope).Each group will receive a demonstration and verbal instruction on how to perform laryngoscopy and tracheal intubation by their instructor.
- Conditions
- Intubation Intraesophageal
- Being tested
- Airtraq, Control group, taught with a standard Macintosh laryngoscope
- Keywords
- Teaching, Video Scope, Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirtraqDevice
Subjects were taught with the Airtraq video laryngoscope
Control group, taught with a standard Macintosh laryngoscopeOther
Subjects were taught how to use the Mackintosh blade first
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Control group, taught with a standard Macintosh laryngoscope Receives: Other: Control group, taught with a standard Macintosh laryngoscope |
| Study group | Experimental | Study group taught with the Airtraq video laryngoscope Receives: Device: Airtraq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Endotracheal Intubation
A successful placement of the endotracheal tube as defined by the presence of bilateral breath sounds and positive recording of end tidal carbon dioxide.
Measured: 120 seconds
Secondary outcomes (1)
Time to Intubation
Time to intubation is the time interval of blade insertion until the removal of the laryngoscope.
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 posted3 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intubation IntraesophagealStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gildasio De Oliveira, Northwestern University
- Investigators
- Gildasio DeOliveira, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080118
- Sponsor's protocol ID
- STU00007644
- Status last verified
- Oct 2013
- First submitted
- 26 Feb 2010
- Last updated
- 2 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial on the Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices
- ClinicalTrials.gov ID
- NCT01080118
- Acronym / sponsor ID
- STU00007644
- Conditions
- Intubation Intraesophageal
- Keywords
- Teaching, Video Scope, Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Posted 4 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of the video laryngoscope to teach laryngoscopy will improve the performance of tracheal intubation done by novices because it will allow a shared view of the airway leading to a better feedback from the trainer to the trainee.
Detailed description
A group of 30 fourth year medical students and interns rotating through the department of anesthesiology will be studied. Firstly, a standard lecture will be provided in which the description and importance of laryngoscopy and tracheal intubation will be explained. This will include descriptions of anatomy, relevant equipment and technique of tracheal intubation. Following the lecture , the students will be randomly allocated using sealed envelopes into two groups : a control group ( taught with a standard Macintosh Laryngoscope ) and a study group ( taught with the Airtraq video laryngoscope).Each group will receive a demonstration and verbal instruction on how to perform laryngoscopy and tracheal intubation by their instructor.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: Control group, taught with a standard Macintosh laryngoscopeControl group, taught with a standard Macintosh laryngoscope |
| Study group | Experimental | Device: AirtraqStudy group taught with the Airtraq video laryngoscope |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Medical student or intern rotating through the anesthesiology department
- Age 18 -75 years of age
- ASA PS I, II
- Procedure that will require General anesthesia with tracheal intubation
Key exclusion criteria (14 listed)
- Previous attempts of laryngoscopy in humans
- Subject who refuses participation
- Age < 18 years old or greater than 75 years of age
- Patient or student who refuses participation
- ASA Physical status class III or greater
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 |
|---|---|---|
| AirtraqSubjects were taught with the Airtraq video laryngoscope | Device | Study group |
| Control group, taught with a standard Macintosh laryngoscopeSubjects were taught how to use the Mackintosh blade first | Other | control group |
Primary outcome
Successful Endotracheal Intubation
Time frame: 120 seconds
A successful placement of the endotracheal tube as defined by the presence of bilateral breath sounds and positive recording of end tidal carbon dioxide.
1 secondary outcome
Time to Intubation
Time frame: 120 seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gildasio DeOliveira, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airtraq in people with Intubation Intraesophageal, run by Northwestern University at 1 site in United States.
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 4 inclusion and 14 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 2 Dec 2013. 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 United States. 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?
Yes. Results are posted in the registry (first posted 4 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Successful Endotracheal Intubation (time frame: 120 seconds). 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 2 Dec 2013.