Intubation; Difficult
Conditions
Keywords
intubating stylet, head and neck position
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHead-lift position
A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.
DEVICE7cm high pillow
A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.
Sponsors
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients scheduled for various surgeries requiring general anesthesia with tracheal intubation * American Society of Anesthesiologists(ASA) physical status classification I-III
Exclusion criteria
* pneumothorax * room air saturation by pulse oximeter saturation less than 96% * vocal cord palsy * craniofacial anomaly * congenital upper airway anomaly * upper airway disease * cervical spine pathology * head and neck tumor status post radiotherapy * an increased risk of regurgitation or pulmonary aspiration * a history of difficult tracheal intubation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intubation Time | from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Pressure | before and after intubation, up to 5 minutes | compare the mean arterial pressure between two groups. |
| Modified Cormack-Lehane Grade | during intubation, after epiglottis was identified on the video monitor | 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. |
| Visual Analog Scale of Sore Throat | after anesthesia emergence 30 minutest, at post-anesthesia care unit | 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. |
Countries
Taiwan
Participant flow
Recruitment details
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
Pre-assignment details
Patient denied to participated, equipment unavailable or malfunction, difficult mask ventilation were excluded .
Participants by arm
| Arm | Count |
|---|---|
| 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. | 62 |
| 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 | 62 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | equipment not available or malfunction | 3 | 3 |
Baseline characteristics
| Characteristic | Head-lift Position | Neutral Position | Total |
|---|---|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 14.8 | 50.0 years STANDARD_DEVIATION 15 | 50.8 years STANDARD_DEVIATION 14.9 |
| Body weight | 66.08 kilogram STANDARD_DEVIATION 15.8 | 66 kilogram STANDARD_DEVIATION 12 | 66 kilogram STANDARD_DEVIATION 14 |
| Height, Thyromental distance, Sternomental distance, Neck length Height | 162.3 cm STANDARD_DEVIATION 8.8 | 161.9 cm STANDARD_DEVIATION 9.1 | 162 cm STANDARD_DEVIATION 9 |
| Height, Thyromental distance, Sternomental distance, Neck length Neck Length | 16.7 cm STANDARD_DEVIATION 1.8 | 17.3 cm STANDARD_DEVIATION 1.7 | 17.0 cm STANDARD_DEVIATION 1.7 |
| Height, Thyromental distance, Sternomental distance, Neck length Sternomental distance | 15.2 cm STANDARD_DEVIATION 1.9 | 15.7 cm STANDARD_DEVIATION 1.8 | 15.5 cm STANDARD_DEVIATION 1.8 |
| Height, Thyromental distance, Sternomental distance, Neck length Thyromental distance | 7.7 cm STANDARD_DEVIATION 1.1 | 8.0 cm STANDARD_DEVIATION 0.9 | 7.8 cm STANDARD_DEVIATION 1 |
| Race/Ethnicity, Customized Asian | 62 participants | 62 participants | 124 participants |
| Region of Enrollment Taiwan | 62 participants | 62 participants | 124 participants |
| Sex: Female, Male Female | 27 Participants | 29 Participants | 56 Participants |
| Sex: Female, Male Male | 35 Participants | 33 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 62 | 0 / 62 |
| serious Total, serious adverse events | 0 / 62 | 0 / 62 |
Outcome results
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.
Time frame: from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Head-lift Position | Intubation Time | 17.5 seconds |
| Neutral Position | Intubation Time | 21 seconds |
Secondary
Mean Arterial Pressure
compare the mean arterial pressure between two groups.
Time frame: before and after intubation, up to 5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Head-lift Position | Mean Arterial Pressure | 82 mmHg | Standard Deviation 14 |
| Neutral Position | Mean Arterial Pressure | 86 mmHg | Standard Deviation 12 |
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.
Time frame: during intubation, after epiglottis was identified on the video monitor
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Head-lift Position | Modified Cormack-Lehane Grade | 2.53 units on a scale |
| Neutral Position | Modified Cormack-Lehane Grade | 1.83 units on a scale |
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.
Time frame: after anesthesia emergence 30 minutest, at post-anesthesia care unit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Head-lift Position | Visual Analog Scale of Sore Throat | 1.82 units on a scale |
| Neutral Position | Visual Analog Scale of Sore Throat | 1.73 units on a scale |