Anesthesia, IntravenousNCT00378170
Laryngoscope Prototype Tested Against the Traditional Macintosh Blade
A study testing intubation of patients undergoing elective surgery in people with Anesthesia, Intravenous, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The primary objective is to evaluate a knewly developed blade (for intubating patients about to undergo surgery) and compare it to the traditional Macintosh blade Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Intravenous
- What is being tested?
- intubation of patients undergoing elective surgery
- Type of treatment
- Medical device
- How many people
- 210 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to not given
- 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 over 18
- ASA 1-III
- Patients undergoing elective surgery requering intubation at KAS Herlev
Who cannot join
- Prior difficult intubation indicating awake fiberoptic intubation
- pathology in the airways predicting difficult intubation
- columna cervicalis fractures
- pregnancy
- Requirement for Rapid sequence induction
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
KAS Herlev university Hospital
Herlev, Herlev, 2730
About this study
The primary objective is to evaluate a knewly developed blade (for intubating patients about to undergo surgery) and compare it to the traditional Macintosh blade
Read the detailed description
Intubation of patiens can be difficult, even impossible. It can result in different complications as damage to the teeth, lacerations of the mucosa, bleeding, fractures/luxations, hypoxia, hypercapnia, reflex bradycardia and in worst case braindamage and death.
The more difficult the intubation is the more frequent complicationrate. We believe to have developed a laryngoscopeblade that hopefully eases the intubationproces and thereby reduces the complicationrisk.
The patients included in this study is patients who are undergoing elective surgery requering intubation.
- Conditions
- Anesthesia, Intravenous
- Being tested
- intubation of patients undergoing elective surgery
- Keywords
- intubation, difficulty, Macintosh, dental damage, complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intubation of patients undergoing elective surgeryDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
succes rate - immediate evaluation
difficulty - immediate evaluation
Secondary outcomes (4)
Cormack & Lehane grading
Time to intubate
Interincissor gap
vissible complication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, IntravenousStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 210 participants
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ann Møller, consultant, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378170
- Sponsor's protocol ID
- Prototype vs Macintosh
- Status last verified
- Nov 2006
- First submitted
- 18 Sep 2006
- Last updated
- 4 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngoscope Prototype Tested Against the Traditional Macintosh Blade
- ClinicalTrials.gov ID
- NCT00378170
- Acronym / sponsor ID
- Prototype vs Macintosh
- Conditions
- Anesthesia, Intravenous
- Keywords
- intubation, difficulty, Macintosh, dental damage, complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jan 2006
- First posted
- 19 Sep 2006 (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 primary objective is to evaluate a knewly developed blade (for intubating patients about to undergo surgery) and compare it to the traditional Macintosh blade
Detailed description
Intubation of patiens can be difficult, even impossible. It can result in different complications as damage to the teeth, lacerations of the mucosa, bleeding, fractures/luxations, hypoxia, hypercapnia, reflex bradycardia and in worst case braindamage and death.
The more difficult the intubation is the more frequent complicationrate. We believe to have developed a laryngoscopeblade that hopefully eases the intubationproces and thereby reduces the complicationrisk.
The patients included in this study is patients who are undergoing elective surgery requering intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
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 over 18
- ASA 1-III
- Patients undergoing elective surgery requering intubation at KAS Herlev
Key exclusion criteria (5 listed)
- Prior difficult intubation indicating awake fiberoptic intubation
- pathology in the airways predicting difficult intubation
- columna cervicalis fractures
- pregnancy
- Requirement for Rapid sequence induction
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 of patients undergoing elective surgery | Device | – |
Primary outcome
succes rate - immediate evaluation
difficulty - immediate evaluation
4 secondary outcomes
Cormack & Lehane grading
Time to intubate
Interincissor gap
vissible complication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2006.
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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.
Ann Møller, consultant study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intubation of patients undergoing elective surgery in people with Anesthesia, Intravenous, run by Herlev Hospital 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 3 inclusion and 5 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 4 Dec 2006. 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 Ulrik Grevstad, MD (+4525348390, basviola@get2net.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
succes rate - immediate evaluation. The study lists 2 primary outcomes in all. 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 4 Dec 2006.