IntubationNCT00935636
An Evaluation of Efficacy of the GlideScope Cobalt Video Baton for Intubation on Children Weighing Less Than 10 Kilograms
An observational study of Intubation, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to collect relevant airway data using the GlideScope Cobalt Video Baton 1 and 2 for intubation in a large cohort of neonates and infants weighing 10 kg or less. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Intubation
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Oct 2011
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Neonates and infants requiring endotracheal intubation under 10 kilograms and in which the attending anesthesiologist decided to use the CGS-CVB will be included in this observational study.
Who may be able to join
- Neonates, infants and children scheduled for surgical procedures under general anesthesia and requiring endotracheal intubation
- Patients age 0 - 2 years
- Weight up to 10 kg
- American Society of Anesthesiologists physical status I-III
Who cannot join
- Patients at risk of pulmonary aspiration,
- Increased intracranial pressure
- Those with congenital cardiac diseases or
- Those with hemodynamic instability
Trial locations and contacts
1 site in 1 country.
United States1 site
Chlidren's Medical Center Dallas
Dallas, Texas, 75235
About this study
The purpose of this study is to collect relevant airway data using the GlideScope Cobalt Video Baton 1 and 2 for intubation in a large cohort of neonates and infants weighing 10 kg or less.
Read the detailed description
Neonates and infants requiring endotracheal intubation and in which the attending anesthesiologist decided to use the CGS-CVB will be included in this observational study. Data will be collected by one of the investigators or the research assistant/coordinator and recorded on a data sheet The data from these forms will be then entered by the investigator or research assistant/coordinator into a database maintained only for this study.
The decision of using the GS-CVB is at the discretion of the attending anesthesiologist. Consequently if consent would be required the anesthesiologist might feel compelled or biased to use the device against his will. This will also require that all possible patients's should be consented which will put a serious strain on the study personal.
- Conditions
- Intubation
- Keywords
- Intubation
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubation
Measured: From the time the ETT enters the mouth until end-tidal carbon dioxide is detected on the monitor screen
Secondary outcomes (1)
The time to laryngoscopic views, number of attempts, and the success rate
Measured: from the time the device enters the mouth until the best view is acknowledged.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Szmuk, University of Texas Southwestern Medical Center
- Investigators
- Peter Szmuk, MD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935636
- Sponsor's protocol ID
- 042009-046
- Status last verified
- Jun 2013
- First submitted
- 2 Jul 2009
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Efficacy of the GlideScope Cobalt Video Baton for Intubation on Children Weighing Less Than 10 Kilograms
- ClinicalTrials.gov ID
- NCT00935636
- Acronym / sponsor ID
- 042009-046
- Conditions
- Intubation
- Keywords
- Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 9 Jul 2009 (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 purpose of this study is to collect relevant airway data using the GlideScope Cobalt Video Baton 1 and 2 for intubation in a large cohort of neonates and infants weighing 10 kg or less.
Detailed description
Neonates and infants requiring endotracheal intubation and in which the attending anesthesiologist decided to use the CGS-CVB will be included in this observational study. Data will be collected by one of the investigators or the research assistant/coordinator and recorded on a data sheet The data from these forms will be then entered by the investigator or research assistant/coordinator into a database maintained only for this study.
The decision of using the GS-CVB is at the discretion of the attending anesthesiologist. Consequently if consent would be required the anesthesiologist might feel compelled or biased to use the device against his will. This will also require that all possible patients's should be consented which will put a serious strain on the study personal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates and infants requiring endotracheal intubation under 10 kilograms and in which the attending anesthesiologist decided to use the CGS-CVB will be included in this observational study.
Key inclusion criteria (4 listed)
- Neonates, infants and children scheduled for surgical procedures under general anesthesia and requiring endotracheal intubation
- Patients age 0 - 2 years
- Weight up to 10 kg
- American Society of Anesthesiologists physical status I-III
Key exclusion criteria (4 listed)
- Patients at risk of pulmonary aspiration,
- Increased intracranial pressure
- Those with congenital cardiac diseases or
- Those with hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to intubation
Time frame: From the time the ETT enters the mouth until end-tidal carbon dioxide is detected on the monitor screen
1 secondary outcome
The time to laryngoscopic views, number of attempts, and the success rate
Time frame: from the time the device enters the mouth until the best view is acknowledged.
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 21 Jun 2013.
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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.
Peter Szmuk, MD principal investigator
UT Southwestern
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 Intubation, run by University of Texas Southwestern Medical Center 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 21 Jun 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?
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: From the time the ETT enters the mouth until end-tidal carbon dioxide is detected on the monitor screen). 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 21 Jun 2013.