AnesthesiaNCT02955511
Comparison of 3 Direct Laryngoscopes for Tracheal Intubation in Patients Undergoing Lumbar Spine Surgery
A study testing Blade MAC size 3, Blade MAC size 3.5 and Inscope Blade size 3.5 in people with Anesthesia and Airway, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Hypothesis The use of Macintosh blade sized #3.5 (vs Macintosh size #3) would reduce the time required to achieve successful tracheal intubation and improve the glottic view. Study objective The purpose of this research study is to compare 3 different laryngoscope blades (sizes: 3.5, 3.5 and 3) and see if the blades… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia, Airway
- What is being tested?
- Blade MAC size 3, Blade MAC size 3.5 and Inscope Blade size 3.5
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2018to 15 Sep 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria:
- Patients undergoing lumbar spine surgery procedures under general anesthesia
- Patients with a documented BMI of <35
- Willingness and ability to sign an informed consent document
- 18 - 80 years of age of either gender
- American Society of Anesthesiologists (ASA) physical status classification I - II or III
- Exclusion Criteria:
- Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation or a difficult tracheal intubation is anticipated
- Patients with history of difficult intubation
- Patients with oxygen saturation less than 95% at room air
- Patients with history facial abnormalities, oral-pharyngeal cancer or reconstructive surgery
- Any pathologies of the mouth, pharynx or larynx, or the access to the airway is restricted
- Patients with Immobilized cervical spine, or history of cervical abnormalities
- Patients with a history of uncontrolled gastroesophageal reflux, hiatus hernia or diabetic gastroparesis
- Any coagulation disorder
- Pregnant patients
- Emergency surgeries
- Any other conditions or use of any medication which may interfere with the conduct of the Study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Comparison of 3 Direct Laryngoscopes: Inscope DL Blade Size 3.5 and DL Blade 3.5 Sun-Med GreenLine®/D™ to DL Blade 3 Sun-Med GreenLine®/D™ for Tracheal Intubation in Patients Undergoing Lumbar Spine Surgery, a Prospective Randomized Study
Hypothesis The use of Macintosh blade sized #3.5 (vs Macintosh size #3) would reduce the time required to achieve successful tracheal intubation and improve the glottic view.
Study objective The purpose of this research study is to compare 3 different laryngoscope blades (sizes: 3.5, 3.5 and 3) and see if the blades size 3.5 will reduce the time required to achieve successful tracheal intubation and improve the physician's view of the glottis compared to the standard direct laryngoscope using the blade size 3, in patients undergoing lumbar surgery.
Read more
Primary end point: time to achieve successful tracheal intubation.
Secondary end points: glottic view at intubation, number of intubation attempts and effectiveness of the integrated suction in the Inscope Direct Laryngoscope.
Read the detailed description
Laryngoscopy is a common medical procedure used during elective and emergency intubations. The procedure is performed with either a direct or video laryngoscope with the device selected dependent on tool availability, provider (i.e. anesthesiologist, emergency physician, ENT physician, paramedic, etc.) preference, patient characteristics, and intubation difficulty. The direct laryngoscope technique involves a line-of-sight view from the patient's mouth to vocal cords along the blade of the scope. The direct laryngoscopy technique is the oldest technique associated with intubation. However, despite continuous improvements to direct laryngoscope size and shape since its inception in the late 19th century, no improvement yet addresses one major problem with airway visualization: the provider will experience a difficult intubation if liquids (i.e. gastric content, blood, mucus, etc.) obstruct the view.
The Sun-Med GreenLine®/D™ Macintosh is a line of disposable direct Macintosh laryngoscopes. It features a stainless steel blade and polycarbonate light-pipe to direct light into the airway. The handle, with integrated batteries and LED light, and blade are separately packaged prior to use. The GreenLine®/D™ Macintosh line is available in the standard sizes (0, 1, 2, 3, 4) and a new size built to improve blade sizing for many adults 3.5 when a Mac 3 is too short, but a Mac 4 is too large. The GreenLine®/D™ Macintosh does not feature integrated suction.
The Inscope Direct Laryngoscope (developed by Inscope Medical Solutions) is a new disposable direct laryngoscope with two integrated and controllable (flow on/off) suction pathways. By integrating controllable suction with two independent pathways into the laryngoscope, the provider is able to select the primary (blade tip) suction pathway to clear secretions ahead of the laryngoscope and the secondary (at blade mid-length, below blade) to prevent and clear fluids that may re-accumulate during the procedure. Integrating the suction into the device prevents the common current practice of "juggling" the current suction catheter and endotracheal (breathing) tube in one hand while holding the patient's airway open with the other hand. While the incidence of aspiration of fluids into the lungs as a result of poor airway fluid management is low, the outcomes associated with this complication are very poor.
The Inscope Direct Laryngoscope has been developed as a Macintosh 3.5 sized blade to meet the size requirements of the majority of patients. This assumption is backed up by a trend among disposable direct laryngoscope manufacturers toward the 3.5 blade size, with at least 5 creating a 3.5 blade, including Teleflex, Sun-Med, Flexicare, Mercury Medical, and Curaplex.
This study will compare the Inscope Direct Laryngoscope (blade size 3.5) with the currently used standard single-use Sun-Med Greenline/D Macintosh laryngoscopes DL-blade mac size and Sun-Med Greenline/D-blade size 3.5.
All Direct Laryngoscopes are considered a Class I exempt device by the FDA. Because the risks associated with laryngoscopes are well known and documented, they are considered a non-significant risk device for studies involving humans.
- Conditions
- Anesthesia, Airway
- Being tested
- Blade MAC size 3, Blade MAC size 3.5, Inscope Blade size 3.5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blade MAC size 3Device
Patient will be intubated using the DL- Blade MAC size 3
Blade MAC size 3.5Device
Patient will be intubated using the DL- Blade MAC size 3.5
Inscope Blade size 3.5Device
Patient will be intubated using the Inscope Blade size 3.5
| Study group | Role | What they receive |
|---|---|---|
| Blade MAC size 3 | Active comparator | Patient will be intubated using a:
Direct Laryngoscope (DL) Mac size 3 (Sun-Med GreenLine®/D™ Macintosh) Receives: Device: Blade MAC size 3 |
| Blade MAC size 3.5 | Active comparator | Patient will be intubated using a:
DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh) Receives: Device: Blade MAC size 3.5 |
| Inscope Blade size 3.5 | Experimental | Patient will be intubated using a:
Inscope DL-blade size 3.5 Receives: Device: Inscope Blade size 3.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Time (Using a Stopwatch)
Intubation Time:
It is the time taken to intubate: from the initial insertion of the laryngoscope blade to the placement of the tracheal tube (approximately 3 minutes).
An intubation attempt:
It is defined as the insertion of the laryngoscope blade into a patient's mouth, with the objective of inserting an endotracheal tube into the trachea.
Measured: up to 3 minutes
Glottis Visualization POGO Score
The percentage of the glottis visualized (POGO) score It represents the percentage of glottic opening seen; the score ranges from 0% when none of the glottis is seen to 100% when the entire glottis, including the anterior commissure, is seen.
Measured: During intubation procedure, up to 1 minute
Time From the Insertion of the Laryngoscope Blade to Confirm w/ CO2 Waveform
The time following the initial insertion of the laryngoscope blade into the mouth to confirm w/ CO2 waveform
Measured: During intubation procedure, up to 3 minutes
Secondary outcomes (2)
Intubation Attempts
An intubation attempt is defined as the insertion of the laryngoscope blade into a patient's mouth, with the objective of inserting an endotracheal tube into the trachea.
The number of intubation attempts in each participant for successful tracheal intubation measured how many times the anesthesiologist attempted to place the tube into the trachea of each patient.
Measured: 3 minutes
Glottis Visualization Using Cormack Lehane
Grade Description Approximate frequency Likelihood of difficult intubation
- Full view of glottis 68-74% <1%
- a Partial view of glottis 21-24% 4.3-13.4%
2b Only posterior extremity of glottis seen or only arytenoid cartilages 3.3-6.5% 65-67.4% 3 Only epiglottis seen, none of glottis seen 1.2-1.6% 80-87.5% 4 Neither glottis nor epiglottis seen very rare
Note:
In the analysis of the data collected for 5 participants, there was no differentiation between "2a" and "2b" for a grade of "2."
Measured: During intubation procedure, up to 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start2 Jan 2018
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Why it stopped: The blade used in the study was modified (changed) by the manufacturer, it does not longer exist.
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 AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
- Investigators
- Roya Yumul, MD, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955511
- Sponsor's protocol ID
- Pro00045198
- Status last verified
- Oct 2022
- First submitted
- 2 Nov 2016
- Last updated
- 19 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 3 Direct Laryngoscopes: Inscope DL Blade Size 3.5 and DL Blade 3.5 Sun-Med GreenLine®/D™ to DL Blade 3 Sun-Med GreenLine®/D™ for Tracheal Intubation in Patients Undergoing Lumbar Spine Surgery, a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02955511
- Acronym / sponsor ID
- Pro00045198
- Conditions
- Anesthesia, Airway
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The blade used in the study was modified (changed) by the manufacturer, it does not longer exist.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Posted 19 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis The use of Macintosh blade sized #3.5 (vs Macintosh size #3) would reduce the time required to achieve successful tracheal intubation and improve the glottic view.
Study objective The purpose of this research study is to compare 3 different laryngoscope blades (sizes: 3.5, 3.5 and 3) and see if the blades size 3.5 will reduce the time required to achieve successful tracheal intubation and improve the physician's view of the glottis compared to the standard direct laryngoscope using the blade size 3, in patients undergoing lumbar surgery.
Primary end point: time to achieve successful tracheal intubation.
Secondary end points: glottic view at intubation, number of intubation attempts and effectiveness of the integrated suction in the Inscope Direct Laryngoscope.
Detailed description
Laryngoscopy is a common medical procedure used during elective and emergency intubations. The procedure is performed with either a direct or video laryngoscope with the device selected dependent on tool availability, provider (i.e. anesthesiologist, emergency physician, ENT physician, paramedic, etc.) preference, patient characteristics, and intubation difficulty. The direct laryngoscope technique involves a line-of-sight view from the patient's mouth to vocal cords along the blade of the scope. The direct laryngoscopy technique is the oldest technique associated with intubation. However, despite continuous improvements to direct laryngoscope size and shape since its inception in the late 19th century, no improvement yet addresses one major problem with airway visualization: the provider will experience a difficult intubation if liquids (i.e. gastric content, blood, mucus, etc.) obstruct the view.
The Sun-Med GreenLine®/D™ Macintosh is a line of disposable direct Macintosh laryngoscopes. It features a stainless steel blade and polycarbonate light-pipe to direct light into the airway. The handle, with integrated batteries and LED light, and blade are separately packaged prior to use. The GreenLine®/D™ Macintosh line is available in the standard sizes (0, 1, 2, 3, 4) and a new size built to improve blade sizing for many adults 3.5 when a Mac 3 is too short, but a Mac 4 is too large. The GreenLine®/D™ Macintosh does not feature integrated suction.
The Inscope Direct Laryngoscope (developed by Inscope Medical Solutions) is a new disposable direct laryngoscope with two integrated and controllable (flow on/off) suction pathways. By integrating controllable suction with two independent pathways into the laryngoscope, the provider is able to select the primary (blade tip) suction pathway to clear secretions ahead of the laryngoscope and the secondary (at blade mid-length, below blade) to prevent and clear fluids that may re-accumulate during the procedure. Integrating the suction into the device prevents the common current practice of "juggling" the current suction catheter and endotracheal (breathing) tube in one hand while holding the patient's airway open with the other hand. While the incidence of aspiration of fluids into the lungs as a result of poor airway fluid management is low, the outcomes associated with this complication are very poor.
The Inscope Direct Laryngoscope has been developed as a Macintosh 3.5 sized blade to meet the size requirements of the majority of patients. This assumption is backed up by a trend among disposable direct laryngoscope manufacturers toward the 3.5 blade size, with at least 5 creating a 3.5 blade, including Teleflex, Sun-Med, Flexicare, Mercury Medical, and Curaplex.
This study will compare the Inscope Direct Laryngoscope (blade size 3.5) with the currently used standard single-use Sun-Med Greenline/D Macintosh laryngoscopes DL-blade mac size and Sun-Med Greenline/D-blade size 3.5.
All Direct Laryngoscopes are considered a Class I exempt device by the FDA. Because the risks associated with laryngoscopes are well known and documented, they are considered a non-significant risk device for studies involving humans.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blade MAC size 3 | Active comparator | Device: Blade MAC size 3Patient will be intubated using a: Direct Laryngoscope (DL) Mac size 3 (Sun-Med GreenLine®/D™ Macintosh) |
| Blade MAC size 3.5 | Active comparator | Device: Blade MAC size 3.5Patient will be intubated using a: DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh) |
| Inscope Blade size 3.5 | Experimental | Device: Inscope Blade size 3.5Patient will be intubated using a: Inscope DL-blade size 3.5 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Blade MAC size 3Patient will be intubated using the DL- Blade MAC size 3 | Device | Blade MAC size 3 |
| Blade MAC size 3.5Patient will be intubated using the DL- Blade MAC size 3.5 | Device | Blade MAC size 3.5 |
| Inscope Blade size 3.5Patient will be intubated using the Inscope Blade size 3.5 | Device | Inscope Blade size 3.5 |
Primary outcome
Intubation Time (Using a Stopwatch)
Time frame: up to 3 minutes
Intubation Time: It is the time taken to intubate: from the initial insertion of the laryngoscope blade to the placement of the tracheal tube (approximately 3 minutes). An intubation attempt: It is defined as the insertion of the laryngoscope blade into a patient's mouth, with the objective of inserting an endotracheal tube into the trachea.
Glottis Visualization POGO Score
Time frame: During intubation procedure, up to 1 minute
The percentage of the glottis visualized (POGO) score It represents the percentage of glottic opening seen; the score ranges from 0% when none of the glottis is seen to 100% when the entire glottis, including the anterior commissure, is seen.
Time From the Insertion of the Laryngoscope Blade to Confirm w/ CO2 Waveform
Time frame: During intubation procedure, up to 3 minutes
The time following the initial insertion of the laryngoscope blade into the mouth to confirm w/ CO2 waveform
2 secondary outcomes
Intubation Attempts
Time frame: 3 minutes
Glottis Visualization Using Cormack Lehane
Time frame: During intubation procedure, up to 1 minute
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- 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.
Roya Yumul, MD, PhD principal investigator
Cedars-Sinai 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 Blade MAC size 3, Blade MAC size 3.5 and Inscope Blade size 3.5 in people with Anesthesia and Airway, run by Cedars-Sinai 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?
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: stopped early, as of the sponsor's last update on 19 Oct 2022. 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 19 Oct 2022). 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?
Intubation Time (Using a Stopwatch) (time frame: up to 3 minutes). The study lists 3 primary outcomes in all. 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 19 Oct 2022.