Endotracheal IntubationNCT01488370
Comparison of 2 Laryngoscopes for Endotracheal Intubation in Children Younger Than 2 Years Old
A study testing Endotracheal intubation in people with Endotracheal Intubation, run by Loma Linda University at 2 sites in United States.
Trial summary
This is a prospective randomized clinical study to be performed in pediatric patients under the age of 2 years who are undergoing surgical procedures requiring endotracheal intubation. Read more about this study
- Who is it for?
- Ages Up to 23 months
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Endotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Jul 2015
- 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 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients under the age of 2 years undergoing surgeries requiring endotracheal intubation at LLUMC will be eligible for participation in this study
Who cannot join
- Children with increased pulmonary aspiration risk;
- Prior documentation of difficult endotracheal intubation;
- Those that lack legal representative consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loma Linda University Department of Anesthesiology
Loma Linda, California, 92354
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Official title: A Comparison of the Glidescope® Video Laryngoscope and the Storz DCI® Video Laryngoscope for Endotracheal Intubation in Children Younger Than Two Years of Age
This is a prospective randomized clinical study to be performed in pediatric patients under the age of 2 years who are undergoing surgical procedures requiring endotracheal intubation. Time to endotracheal intubation will be compared between patients intubated using a GlideScope® video laryngoscope, those intubated with a Storz DCI® video laryngoscope, and those intubated by standard direct laryngoscopy. The study hypothesis is that the time to endotracheal intubation will be decreased in the Storz DCI® video laryngoscope group when compared to the GlideScope® video laryngoscope group and standard laryngoscopy.
- Conditions
- Endotracheal Intubation
- Being tested
- Endotracheal intubation
- Keywords
- breathing tube placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationDevice
Also called Storz DCI video laryngoscope, Glidescope video laryngoscope
Endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Glidescope | Active comparator | A device for endotracheal intubation. Receives: Device: Endotracheal intubation |
| Storz | Active comparator | A device for endotracheal intubation. Receives: Device: Endotracheal intubation |
| Standard Laryngoscope | Active comparator | A device for endotracheal intubation Receives: Device: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation.
Measured: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia
Secondary outcomes (4)
Successful Intubation After One Laryngoscopy Attempt
Other secondary outcome measures will be the use of external laryngeal manipulation to improve glottic view, tissue trauma and type,and method of rescue if initial intubation attempt proves unsuccessful.
Measured: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
Successful Intubation After Two Laryngoscopy Attempts
Measured: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
Successful Intubation After Three Laryngoscopy Attempts
Measured: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
Successful Intubation After Four Laryngoscopy Attempts
Measured: Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2015
- Study completionJul 2015
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 Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by Loma Linda 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Ghazal, Loma Linda University
- Investigators
- Elizabeth Ghazal, MD, Principal investigator, Loma Linda University Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488370
- Sponsor's protocol ID
- 5110244
- Status last verified
- Mar 2019
- First submitted
- 1 Nov 2011
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Glidescope® Video Laryngoscope and the Storz DCI® Video Laryngoscope for Endotracheal Intubation in Children Younger Than Two Years of Age
- ClinicalTrials.gov ID
- NCT01488370
- Acronym / sponsor ID
- 5110244
- Conditions
- Endotracheal Intubation
- Keywords
- breathing tube placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Posted 18 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized clinical study to be performed in pediatric patients under the age of 2 years who are undergoing surgical procedures requiring endotracheal intubation. Time to endotracheal intubation will be compared between patients intubated using a GlideScope® video laryngoscope, those intubated with a Storz DCI® video laryngoscope, and those intubated by standard direct laryngoscopy. The study hypothesis is that the time to endotracheal intubation will be decreased in the Storz DCI® video laryngoscope group when compared to the GlideScope® video laryngoscope group and standard laryngoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glidescope | Active comparator | Device: Endotracheal intubationA device for endotracheal intubation. |
| Storz | Active comparator | Device: Endotracheal intubationA device for endotracheal intubation. |
| Standard Laryngoscope | Active comparator | Device: Endotracheal intubationA device for endotracheal intubation |
Who may qualify
- Ages
- Up to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients under the age of 2 years undergoing surgeries requiring endotracheal intubation at LLUMC will be eligible for participation in this study
Key exclusion criteria (3 listed)
- Children with increased pulmonary aspiration risk;
- Prior documentation of difficult endotracheal intubation;
- Those that lack legal representative consent
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 |
|---|---|---|
| Endotracheal intubationAlso: Storz DCI video laryngoscope, Glidescope video laryngoscopeEndotracheal intubation | Device | Glidescope, Standard Laryngoscope, Storz |
Primary outcome
Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation.
Time frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia
4 secondary outcomes
Successful Intubation After One Laryngoscopy Attempt
Time frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
Successful Intubation After Two Laryngoscopy Attempts
Time frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
Successful Intubation After Three Laryngoscopy Attempts
Time frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.
Successful Intubation After Four Laryngoscopy Attempts
Time frame: Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Elizabeth Ghazal, MD principal investigator
Loma Linda University Department of Anesthesiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal intubation in people with Endotracheal Intubation, run by Loma Linda University at 2 sites 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 1 inclusion and 3 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 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 May 2017). 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?
Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation. (time frame: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia). 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 26 Mar 2019.