IntubationNCT01163656
Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants
A study testing Miller Laryngoscope and Glidescope Cobalt Video Laryngoscopes in people with Intubation, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Intubation
- What is being tested?
- Miller Laryngoscope and Glidescope Cobalt Video Laryngoscopes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Mar 2012
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Scheduled to undergo elective surgery at CHOP
- American Society of Anesthesiologists (ASA) Physical Status I or II
- Anesthetic plan requiring tracheal intubation with a neuromuscular relaxant
- Parental/guardian permission (informed consent). Subjects will be too young to understand the study procedures and therefore assent will not be sought. -
Who cannot join
- At known or anticipated high risk for aspiration pneumonia
- Known or predicted difficult intubation as assessed by the clinical attending anesthesiologist
- Emergency surgical procedure
- Patients with preoperative airway pathology or stridor -
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Prospective Comparison of the Glidescope Cobalt to Standard Direct Laryngoscopy in Infants
The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.
Read the detailed description
We seek to study the intubation characteristics of a new video laryngoscope, the Glidescope Cobalt in children less than or equal to 1 yr of age. This evaluation would provide insight as to the efficacy of this device in facilitating intubation in infants.
- Conditions
- Intubation
- Being tested
- Miller Laryngoscope, Glidescope Cobalt Video Laryngoscopes
- Keywords
- Neonate, Laryngoscopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miller LaryngoscopeDevice
Also called tracheal intubation, laryngoscopy, direct laryngoscopy
Device is used to facilitate tracheal intubation.
Glidescope Cobalt Video LaryngoscopesDevice
Also called Glidescope Cobalt Video Laryngoscopy, Video Laryngoscopy
The laryngoscope design with the integration of video technology into the laryngoscope blade.
| Study group | Role | What they receive |
|---|---|---|
| Direct Laryngoscopy | Active comparator | Laryngoscopy will be performed with the randomized device, which will be the Miller Laryngoscope. Receives: Device: Miller Laryngoscope |
| Glidescope Cobalt Video Laryngoscopy | Active comparator | Laryngoscopy will be performed with the randomized device, which will be the Glidescope Cobalt Video Laryngoscope. Receives: Device: Glidescope Cobalt Video Laryngoscopes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Tracheal Intubation
The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.
Measured: Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionFeb 2011
- Study completionMar 2012
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 IntubationStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Fiadjoe, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163656
- Sponsor's protocol ID
- 10-007533
- Status last verified
- Jan 2013
- First submitted
- 13 Jul 2010
- Last updated
- 31 Jan 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 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of the Glidescope Cobalt to Standard Direct Laryngoscopy in Infants
- ClinicalTrials.gov ID
- NCT01163656
- Acronym / sponsor ID
- 10-007533
- Conditions
- Intubation
- Keywords
- Neonate, Laryngoscopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Posted 18 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.
Detailed description
We seek to study the intubation characteristics of a new video laryngoscope, the Glidescope Cobalt in children less than or equal to 1 yr of age. This evaluation would provide insight as to the efficacy of this device in facilitating intubation in infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Laryngoscopy | Active comparator | Device: Miller LaryngoscopeLaryngoscopy will be performed with the randomized device, which will be the Miller Laryngoscope. |
| Glidescope Cobalt Video Laryngoscopy | Active comparator | Device: Glidescope Cobalt Video LaryngoscopesLaryngoscopy will be performed with the randomized device, which will be the Glidescope Cobalt Video Laryngoscope. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Scheduled to undergo elective surgery at CHOP
- American Society of Anesthesiologists (ASA) Physical Status I or II
- Anesthetic plan requiring tracheal intubation with a neuromuscular relaxant
- Parental/guardian permission (informed consent). Subjects will be too young to understand the study procedures and therefore assent will not be sought. -
Key exclusion criteria (4 listed)
- At known or anticipated high risk for aspiration pneumonia
- Known or predicted difficult intubation as assessed by the clinical attending anesthesiologist
- Emergency surgical procedure
- Patients with preoperative airway pathology or stridor -
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 |
|---|---|---|
| Miller LaryngoscopeAlso: tracheal intubation, laryngoscopy, direct laryngoscopyDevice is used to facilitate tracheal intubation. | Device | Direct Laryngoscopy |
| Glidescope Cobalt Video LaryngoscopesAlso: Glidescope Cobalt Video Laryngoscopy, Video LaryngoscopyThe laryngoscope design with the integration of video technology into the laryngoscope blade. | Device | Glidescope Cobalt Video Laryngoscopy |
Primary outcome
Time to Tracheal Intubation
Time frame: Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.
The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 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.
John Fiadjoe, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miller Laryngoscope and Glidescope Cobalt Video Laryngoscopes in people with Intubation, run by Children's Hospital of Philadelphia 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 4 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 31 Jan 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 18 Jan 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?
Time to Tracheal Intubation (time frame: Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.). 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 31 Jan 2013.