Trial Outcomes & Findings for "Neutral Head Position" and "Head-lift Position" for Orotracheal Intubation With "Trachway" Intubating Stylet in Adults (NCT NCT02578992)

NCT ID: NCT02578992

Last Updated: 2016-12-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 130 participants
• Primary outcome timeframe: from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts
• Results posted on: 2016-12-09

Participant Flow

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

Patient denied to participated, equipment unavailable or malfunction, difficult mask ventilation were excluded .

Participant milestones

Measure	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.	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
Overall Study STARTED	65	65
Overall Study COMPLETED	62	62
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	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.	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
Overall Study equipment not available or malfunction	3	3

Baseline Characteristics

"Neutral Head Position" and "Head-lift Position" for Orotracheal Intubation With "Trachway" Intubating Stylet in Adults

Baseline characteristics by cohort

Measure	Head-lift Position n=62 Participants 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.	Neutral Position n=62 Participants The patients' head was placed in the neutral position and then the patient was intubated with Trachway by single-handed chin lift technique	Total n=124 Participants Total of all reporting groups
Age, Continuous	51.6 years STANDARD_DEVIATION 14.8 • n=5 Participants	50.0 years STANDARD_DEVIATION 15.0 • n=7 Participants	50.8 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	33 Participants n=7 Participants	68 Participants n=5 Participants
Race/Ethnicity, Customized Asian	62 participants n=5 Participants	62 participants n=7 Participants	124 participants n=5 Participants
Region of Enrollment Taiwan	62 participants n=5 Participants	62 participants n=7 Participants	124 participants n=5 Participants
Height, Thyromental distance, Sternomental distance, Neck length Height	162.3 cm STANDARD_DEVIATION 8.8 • n=5 Participants	161.9 cm STANDARD_DEVIATION 9.1 • n=7 Participants	162 cm STANDARD_DEVIATION 9 • n=5 Participants
Height, Thyromental distance, Sternomental distance, Neck length Thyromental distance	7.7 cm STANDARD_DEVIATION 1.1 • n=5 Participants	8.0 cm STANDARD_DEVIATION 0.9 • n=7 Participants	7.8 cm STANDARD_DEVIATION 1.0 • n=5 Participants
Height, Thyromental distance, Sternomental distance, Neck length Sternomental distance	15.2 cm STANDARD_DEVIATION 1.9 • n=5 Participants	15.7 cm STANDARD_DEVIATION 1.8 • n=7 Participants	15.5 cm STANDARD_DEVIATION 1.8 • n=5 Participants
Height, Thyromental distance, Sternomental distance, Neck length Neck Length	16.7 cm STANDARD_DEVIATION 1.8 • n=5 Participants	17.3 cm STANDARD_DEVIATION 1.7 • n=7 Participants	17.0 cm STANDARD_DEVIATION 1.7 • n=5 Participants
Body weight	66.08 kilogram STANDARD_DEVIATION 15.8 • n=5 Participants	66 kilogram STANDARD_DEVIATION 12 • n=7 Participants	66 kilogram STANDARD_DEVIATION 14 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Head-lift Position n=62 Participants 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.	Neutral Position n=62 Participants 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
Intubation Time	17.5 seconds Interval 15.0 to 20.0	21 seconds Interval 19.0 to 23.25

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Head-lift Position n=62 Participants 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.	Neutral Position n=62 Participants 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
Modified Cormack-Lehane Grade	2.53 units on a scale Interval 1.0 to 4.0	1.83 units on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: before and after intubation, up to 5 minutes

compare the mean arterial pressure between two groups.

Outcome measures

Measure	Head-lift Position n=62 Participants 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.	Neutral Position n=62 Participants 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
Mean Arterial Pressure	82 mmHg Standard Deviation 14	86 mmHg Standard Deviation 12

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Head-lift Position n=62 Participants 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.	Neutral Position n=62 Participants 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
Visual Analog Scale of Sore Throat	1.82 units on a scale Interval 0.0 to 10.0	1.73 units on a scale Interval 0.0 to 10.0

Adverse Events

Head-lift Position

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Neutral Position

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Wei-Hung Chan

Tri-Service General Hospital

Phone: +886-2-87927128

Email: whcken@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place