Intubation, EndotrachealNCT01865643
A Comparison of Two GlideScope Intubation Techniques
A study testing GlideScope in people with Intubation, Endotracheal and Anesthesia, General, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
The aim of this study is to compare the hemodynamic response to tracheal intubations using the standard technique versus the alternative GS intubation technique. As secondary outcomes the investigators will analyze procedure time, success rate and injury rate. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation, Endotracheal, Anesthesia, General
- What is being tested?
- GlideScope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to May 2014
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of ASA physical status 1-2
- Patients aged 18 years and older
- Patients undergoing elective surgery that requires tracheal intubation
Who cannot join
- Patients in whom a rapid sequence intubation or alternative intubation method is indicated
- Patients with a known or suspected oral, pharyngeal or laryngeal mass
- Patients previously flagged as a difficult intubation
- Patients with hypertension (treated or untreated, poor dentition, symptomatic gastro-esophageal reflux or cervical spine instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Two GlideScope Intubation Techniques - Effect on Hemodynamic Changes and Injury Rate
The aim of this study is to compare the hemodynamic response to tracheal intubations using the standard technique versus the alternative GS intubation technique. As secondary outcomes the investigators will analyze procedure time, success rate and injury rate.
The investigators hypothesize that the alternative intubation technique will have a shorter procedure time and lower injury rate when compared to the standard technique of GS intubation.
Read the detailed description
A Difficult intubation is still one of the most daunting challenges in anesthesiology. One of the tools used to assist with a difficult tracheal intubation is the GlideScope (GS) (Verathon, Bothell, WA, USA). The GS is a video laryngoscope that has a 60 degree angle blade with a built-in high-resolution camera and a light source assembled beside it. The image is transmitted onto a mobile bedside monitor. It has been widely used in medicine for over a decade. The GS was designed to provide an improved view of the glottis during difficult intubations without alignment of the oral, pharyngeal and tracheal axes, as it is able to "look around the corner" to facilitate the intubation.
The standard technique of the GS intubation involves a midline laryngoscopy followed by the insertion of a styleted endotracheal tube (ETT) once an adequate view of the vocal cords has been achieved. The ETT insertion process requires the operator to look away from the monitor during the laryngoscopy while maintaining the blade position in order to insert it into its initial position.
An alternative GS intubation technique has been described for cases in which there is limited mouth opening, a big tongue or other anatomical impediments. In these cases the ETT is inserted under direct vision as a "fish hook" at the side of the mouth before the GS blade is introduced into the oropharynx.
There are several advantages to this alternative technique. The first advantage is that this technique of ETT insertion would minimize the laryngoscopy time as a part of it is performed before the blade is introduced and the stimulating effect occurs. This technique thus has the potential of reducing the sympathetic response. Minimizing oropharyngo-laryngeal stimulation time would theoretically attenuate the hemodynamic response.
- Conditions
- Intubation, Endotracheal, Anesthesia, General
- Being tested
- GlideScope
- Keywords
- Laryngoscopy, Intubation, Glidescope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlideScopeDevice
The GlideScope is used to assist with difficult tracheal intubation.
| Study group | Role | What they receive |
|---|---|---|
| Standard GlideScope intubation | Other | This standard GlideScope (GS) technique involves a midline larygoscopy followed by insertion of a styleted endotracheal tube, once an adequate view of the vocal cords is achieved. Receives: Device: GlideScope |
| Alternative GlideScope intubation | Experimental | Alternative GlideScope (GS) intubation involves the insertion of the endotracheal tube under direct vision as a "fish hook" at the side of the mouth before the GS blade is introduced into the oropharynx. Receives: Device: GlideScope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic response to tracheal intubation
Heart rate and non-invasive blood pressure will be measured before induction, and throughout and after laryngoscopy and induction
Measured: 24 hours
Secondary outcomes (3)
Procedure time
Time for intubation will be measured as time from laryngoscopy to the inflation of the ETT cuff.
Measured: 10 minutes
Success rate
Successful placement of endotracheal tube between the vocal cords.
Measured: 10 minutes
Injury rate
Injuries to the oropharynx
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, EndotrachealStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeev Friedman, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865643
- Sponsor's protocol ID
- 13-03
- Status last verified
- Aug 2014
- First submitted
- 28 May 2013
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two GlideScope Intubation Techniques - Effect on Hemodynamic Changes and Injury Rate
- ClinicalTrials.gov ID
- NCT01865643
- Acronym / sponsor ID
- 13-03
- Conditions
- Intubation, Endotracheal, Anesthesia, General
- Keywords
- Laryngoscopy, Intubation, Glidescope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 31 May 2013 (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 aim of this study is to compare the hemodynamic response to tracheal intubations using the standard technique versus the alternative GS intubation technique. As secondary outcomes the investigators will analyze procedure time, success rate and injury rate.
The investigators hypothesize that the alternative intubation technique will have a shorter procedure time and lower injury rate when compared to the standard technique of GS intubation.
Detailed description
A Difficult intubation is still one of the most daunting challenges in anesthesiology. One of the tools used to assist with a difficult tracheal intubation is the GlideScope (GS) (Verathon, Bothell, WA, USA). The GS is a video laryngoscope that has a 60 degree angle blade with a built-in high-resolution camera and a light source assembled beside it. The image is transmitted onto a mobile bedside monitor. It has been widely used in medicine for over a decade. The GS was designed to provide an improved view of the glottis during difficult intubations without alignment of the oral, pharyngeal and tracheal axes, as it is able to "look around the corner" to facilitate the intubation.
The standard technique of the GS intubation involves a midline laryngoscopy followed by the insertion of a styleted endotracheal tube (ETT) once an adequate view of the vocal cords has been achieved. The ETT insertion process requires the operator to look away from the monitor during the laryngoscopy while maintaining the blade position in order to insert it into its initial position.
An alternative GS intubation technique has been described for cases in which there is limited mouth opening, a big tongue or other anatomical impediments. In these cases the ETT is inserted under direct vision as a "fish hook" at the side of the mouth before the GS blade is introduced into the oropharynx.
There are several advantages to this alternative technique. The first advantage is that this technique of ETT insertion would minimize the laryngoscopy time as a part of it is performed before the blade is introduced and the stimulating effect occurs. This technique thus has the potential of reducing the sympathetic response. Minimizing oropharyngo-laryngeal stimulation time would theoretically attenuate the hemodynamic response.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard GlideScope intubation | Other | Device: GlideScopeThis standard GlideScope (GS) technique involves a midline larygoscopy followed by insertion of a styleted endotracheal tube, once an adequate view of the vocal cords is achieved. |
| Alternative GlideScope intubation | Experimental | Device: GlideScopeAlternative GlideScope (GS) intubation involves the insertion of the endotracheal tube under direct vision as a "fish hook" at the side of the mouth before the GS blade is introduced into the oropharynx. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of ASA physical status 1-2
- Patients aged 18 years and older
- Patients undergoing elective surgery that requires tracheal intubation
Key exclusion criteria (4 listed)
- Patients in whom a rapid sequence intubation or alternative intubation method is indicated
- Patients with a known or suspected oral, pharyngeal or laryngeal mass
- Patients previously flagged as a difficult intubation
- Patients with hypertension (treated or untreated, poor dentition, symptomatic gastro-esophageal reflux or cervical spine instability
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 |
|---|---|---|
| GlideScopeThe GlideScope is used to assist with difficult tracheal intubation. | Device | Alternative GlideScope intubation, Standard GlideScope intubation |
Primary outcome
Hemodynamic response to tracheal intubation
Time frame: 24 hours
Heart rate and non-invasive blood pressure will be measured before induction, and throughout and after laryngoscopy and induction
3 secondary outcomes
Procedure time
Time frame: 10 minutes
Success rate
Time frame: 10 minutes
Injury rate
Time frame: 30 minutes
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 Aug 2014.
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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.
Zeev Friedman, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlideScope in people with Intubation, Endotracheal and Anesthesia, General, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 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 Aug 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 Canada. 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?
Hemodynamic response to tracheal intubation (time frame: 24 hours). 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 Aug 2014.