Respiratory FailureNCT01683526
Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope
A study testing Direct laryngoscopy and Video laryngoscopy (Glidescope) in people with Respiratory Failure, run by Beth Israel Medical Center at 1 site in United States.
Trial summary
The safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent endotracheal intubation of critically-ill patients has not been well-described in the literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Direct laryngoscopy and Video laryngoscopy (Glidescope)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Apr 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing urgent endotracheal intubation by a pulmonary critical care medicine physician
Who cannot join
- Difficult airway
- Oxygen saturation < 92% despite adequate mask ventilation
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Isreal Medical Center
New York, New York, 10003
About this study
Official title: Safety and Efficacy of Endotracheal Intubation by Pulmonary Critical Care Physicians in Critically-Ill Patients Using Glidescope Video-Laryngoscope
The safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent endotracheal intubation of critically-ill patients has not been well-described in the literature. This study will answer whether using a VL will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.
- Conditions
- Respiratory Failure
- Being tested
- Direct laryngoscopy, Video laryngoscopy (Glidescope)
- Keywords
- Urgent endotrachel intubation, Direct laryngoscopy, Video laryngoscopy, Glidescope, Critical Care
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct laryngoscopyProcedure or surgery
Also called standard laryngoscope
Video laryngoscopy (Glidescope)Device
Also called Glidescope Video Laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Direct laryngoscopy | Active comparator | Intubation will be done using direct laryngoscopy Receives: Procedure: Direct laryngoscopy |
| Video laryngoscopy | Active comparator | Intubation will be done using video laryngoscopy Receives: Device: Video laryngoscopy (Glidescope) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Pass Success Rate
Measured: From begining of intubation to verification. Less then 5 minutes approximatly
Secondary outcomes (4)
Severe Desaturation
sat <80%
Measured: For 10 minutes post intubation
Hypotension
SBP<70
Measured: For 10 minutes post intubation
Cardiac Arrest
Measured: For 1 hour post intubation
Complications of Intubation
Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.
Measured: For 10 minutes post intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionApr 2013
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 Respiratory FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Silverberg, MD, Principal investigator, Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683526
- Sponsor's protocol ID
- 139-12
- Status last verified
- Oct 2014
- First submitted
- 6 Sep 2012
- Last updated
- 20 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Endotracheal Intubation by Pulmonary Critical Care Physicians in Critically-Ill Patients Using Glidescope Video-Laryngoscope
- ClinicalTrials.gov ID
- NCT01683526
- Acronym / sponsor ID
- 139-12
- Conditions
- Respiratory Failure
- Keywords
- Urgent endotrachel intubation, Direct laryngoscopy, Video laryngoscopy, Glidescope, Critical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Sep 2012 (estimated)
- Results
- Posted 25 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent endotracheal intubation of critically-ill patients has not been well-described in the literature. This study will answer whether using a VL will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.
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 | Procedure: Direct laryngoscopyIntubation will be done using direct laryngoscopy |
| Video laryngoscopy | Active comparator | Device: Video laryngoscopy (Glidescope)Intubation will be done using video laryngoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing urgent endotracheal intubation by a pulmonary critical care medicine physician
Key exclusion criteria (2 listed)
- Difficult airway
- Oxygen saturation < 92% despite adequate mask ventilation
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 |
|---|---|---|
| Direct laryngoscopyAlso: standard laryngoscope | Procedure or surgery | Direct laryngoscopy |
| Video laryngoscopy (Glidescope)Also: Glidescope Video Laryngoscope | Device | Video laryngoscopy |
Primary outcome
First Pass Success Rate
Time frame: From begining of intubation to verification. Less then 5 minutes approximatly
4 secondary outcomes
Severe Desaturation
Time frame: For 10 minutes post intubation
Hypotension
Time frame: For 10 minutes post intubation
Cardiac Arrest
Time frame: For 1 hour post intubation
Complications of Intubation
Time frame: For 10 minutes post intubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
- 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.
Michael Silverberg, MD principal investigator
Beth Israel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct laryngoscopy and Video laryngoscopy (Glidescope) in people with Respiratory Failure, run by Beth Israel 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 1 inclusion and 2 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 20 Oct 2014. 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 25 Jun 2014). 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?
First Pass Success Rate (time frame: From begining of intubation to verification. Less then 5 minutes approximatly). 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 20 Oct 2014.