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The purpose of this study is to investigate two different patient's head and neck positions(neutral head position and head-lift position) for the effectiveness of orotracheal intubation with using the "Clarus Video System (Trachway®)" intubating stylet.
The sniffing position has traditionally been considered the optimal head position for direct laryngoscopy, However, it may aggravate cervical spine injury. The Trachway® video stylet is an intubating device that may avoid cervical movement during intubation. Nonetheless, the effectiveness of limited neck movement in patients with neutral head or head-lift position using the Trachway® video stylet remains unclear. The purpose of this study was to compare the intubation time of the two positions with the Trachway® video stylet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Head-lift Position | Experimental | The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position) and then the patient was intubated with Trachway by single-handed chin lift technique |
|
| Neutral Position | No Intervention | The patients' head was placed in the neutral position and then the patient was intubated with Trachway by single-handed chin lift technique |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Head-lift position | Procedure | A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intubation Time | the interval from the intubating stylet touched the mouth to capnogram shown, with all attempts, and was recorded by an independent observer with a stop watch. | from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Cormack-Lehane Grade | The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor. Scale range (1, 2, 3, 4). Grade 1 is considered to be a better outcome while grade 4 is considered to be a worse outcome. | during intubation, after epiglottis was identified on the video monitor |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Taipei | Taiwan | 114 | Taiwan |
Patient denied to participated, equipment unavailable or malfunction, difficult mask ventilation were excluded .
Patients aged 20-80 years who were scheduled for various surgeries requiring general anesthesia with tracheal intubation were recruited. All patients exhibited an American Society of Anesthesiologists physical status of I-III. From November 2014 to October 2015
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| ID | Title | Description |
|---|---|---|
| FG000 | Head-lift Position | The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique Head-lift position: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation. 7cm high pillow: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation. |
| FG001 | Neutral Position | The patients' head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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age from 20-80
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| ID | Title | Description |
|---|---|---|
| BG000 | Head-lift Position | The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position) and then the patient was intubated with Trachway by single-handed chin lift technique Head-lift position: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation. 7cm high pillow: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | the interval from the intubating stylet touched the mouth to capnogram shown, with all attempts, and was recorded by an independent observer with a stop watch. | Posted | Median | Inter-Quartile Range | seconds | from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts |
|
1 day
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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 | Head-lift Position | The patients' head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients' head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique Head-lift position: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation. 7cm high pillow: A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation. |
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Tracheal intubation with Trachway was performed by an novice anesthesiologist.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wei-Hung Chan | Tri-Service General Hospital | +886-2-87927128 | whcken@gmail.com |
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| 7cm high pillow | Device | A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation. |
|
| Mean Arterial Pressure | compare the mean arterial pressure between two groups. | before and after intubation, up to 5 minutes |
| Visual Analog Scale of Sore Throat | All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit. Scale range: 0-10. 0 is considered to be a better outcome while 10 is a worse outcome. | after anesthesia emergence 30 minutest, at post-anesthesia care unit |
| BG001 | Neutral Position | The patients' head was placed in the neutral position and then the patient was intubated with Trachway by single-handed chin lift technique |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Height, Thyromental distance, Sternomental distance, Neck length | Mean | Standard Deviation | cm |
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| Body weight | Mean | Standard Deviation | kilogram |
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| OG001 | Neutral Position | The patients' head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique |
|
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| Secondary | Modified Cormack-Lehane Grade | The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor. Scale range (1, 2, 3, 4). Grade 1 is considered to be a better outcome while grade 4 is considered to be a worse outcome. | Posted | Mean | Full Range | units on a scale | during intubation, after epiglottis was identified on the video monitor |
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| Secondary | Mean Arterial Pressure | compare the mean arterial pressure between two groups. | Posted | Mean | Standard Deviation | mmHg | before and after intubation, up to 5 minutes |
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| Secondary | Visual Analog Scale of Sore Throat | All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit. Scale range: 0-10. 0 is considered to be a better outcome while 10 is a worse outcome. | Posted | Mean | Full Range | units on a scale | after anesthesia emergence 30 minutest, at post-anesthesia care unit |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Neutral Position | The patients' head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique | 0 | 62 | 0 | 62 |
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