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The blade used in the study was modified (changed) by the manufacturer, it does not longer exist.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blade MAC size 3 | Active Comparator | Patient will be intubated using a: Direct Laryngoscope (DL) Mac size 3 (Sun-Med GreenLine®/D™ Macintosh) |
|
| Blade MAC size 3.5 | Active Comparator | Patient will be intubated using a: DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh) |
|
| Inscope Blade size 3.5 | Experimental | Patient will be intubated using a: Inscope DL-blade size 3.5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blade MAC size 3 | Device | Patient will be intubated using the DL- Blade MAC size 3 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | During intubation procedure, up to 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 minutes |
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A. Inclusion Criteria:
B. Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roya Yumul, MD, PhD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Blade MAC Size 3 | Patient will be intubated using a: Direct Laryngoscope (DL) Mac size 3 (Sun-Med GreenLine®/D™ Macintosh) Blade MAC size 3: Patient will be intubated using the DL- Blade MAC size 3 |
| FG001 | Blade MAC Size 3.5 | Patient will be intubated using a: DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh) Blade MAC size 3.5: Patient will be intubated using the DL- Blade MAC size 3.5 |
| FG002 | Inscope Blade Size 3.5 | Patient will be intubated using a: Inscope DL-blade size 3.5 Inscope Blade size 3.5: Patient will be intubated using the Inscope Blade size 3.5 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Blade MAC Size 3 | Patient will be intubated using a: Direct Laryngoscope (DL) Mac size 3 (Sun-Med GreenLine®/D™ Macintosh) Blade MAC size 3: Patient will be intubated using the DL- Blade MAC size 3 |
| BG001 | Blade MAC Size 3.5 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Measure Description: The study was terminated early, only FIVE (5) subjects total were enrolled for the three arms groups. It is impossible to produce meaningful results having only five subjects enrolled. | Posted | Mean | Standard Deviation | Seconds | up to 3 minutes |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blade MAC Size 3 | Patient will be intubated using a: Direct Laryngoscope (DL) Mac size 3 (Sun-Med GreenLine®/D™ Macintosh) Blade MAC size 3: Patient will be intubated using the DL- Blade MAC size 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ofelia Loani Elvir Lazo, Research Project Advisor | Cedars Sinai Medical Center | 3104231682 | ofelia.elvir-lazo@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2016 | Jun 10, 2022 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2016 | Jun 10, 2022 | SAP_004.pdf |
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| Blade MAC size 3.5 |
| Device |
Patient will be intubated using the DL- Blade MAC size 3.5 |
|
| Inscope Blade size 3.5 | Device | Patient will be intubated using the Inscope Blade size 3.5 |
|
| Glottis Visualization Using Cormack Lehane | Grade Description Approximate frequency Likelihood of difficult intubation
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." | During intubation procedure, up to 1 minute |
Patient will be intubated using a:
DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh)
Blade MAC size 3.5: Patient will be intubated using the DL- Blade MAC size 3.5
| BG002 | Inscope Blade Size 3.5 | Patient will be intubated using a: Inscope DL-blade size 3.5 Inscope Blade size 3.5: Patient will be intubated using the Inscope Blade size 3.5 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Blade MAC Size 3.5 | Patient will be intubated using a: DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh) Blade MAC size 3.5: Patient will be intubated using the DL- Blade MAC size 3.5 |
| OG002 | Inscope Blade Size 3.5 | Patient will be intubated using a: Inscope DL-blade size 3.5 Inscope Blade size 3.5: Patient will be intubated using the Inscope Blade size 3.5 |
|
|
| Primary | 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. | Measure Description: The study was terminated early, only FIVE (5) subjects total were enrolled for the three arms groups. It is impossible to produce meaningful results having only five subjects enrolled. | Posted | Mean | Standard Deviation | percentage of glottic opening | During intubation procedure, up to 1 minute |
|
|
|
| Primary | 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 | Measure Description: The study was terminated early, only FIVE (5) subjects total were enrolled for the three arms groups. It is impossible to produce meaningful results having only five subjects enrolled. | Posted | Mean | Standard Deviation | Seconds | During intubation procedure, up to 3 minutes |
|
|
|
| Secondary | 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. | Measure Description: The study was terminated early, only FIVE (5) subjects total were enrolled for the three arms groups. It is impossible to produce meaningful results having only five subjects enrolled. | Posted | Mean | Standard Deviation | Intubation Attempts | 3 minutes |
|
|
|
| Secondary | Glottis Visualization Using Cormack Lehane | Grade Description Approximate frequency Likelihood of difficult intubation
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." | Measure Description: The study was terminated early, only FIVE (5) subjects total were enrolled for the three arms groups. It is impossible to produce meaningful results having only five subjects enrolled. | Posted | Mean | Standard Deviation | score on a scale | During intubation procedure, up to 1 minute |
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| 1 |
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| 1 |
| EG001 | Blade MAC Size 3.5 | Patient will be intubated using a: DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh) Blade MAC size 3.5: Patient will be intubated using the DL- Blade MAC size 3.5 | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Inscope Blade Size 3.5 | Patient will be intubated using a: Inscope DL-blade size 3.5 Inscope Blade size 3.5: Patient will be intubated using the Inscope Blade size 3.5 | 0 | 1 | 0 | 1 | 0 | 1 |
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