Intubation; DifficultNCT02578992
"Neutral Head Position" and "Head-lift Position" for Orotracheal Intubation With "Trachway" Intubating Stylet in Adults
A study testing Head-lift position and 7cm high pillow in people with Intubation; Difficult, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Intubation; Difficult
- What is being tested?
- Head-lift position and 7cm high pillow
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2014to Oct 2015
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for various surgeries requiring general anesthesia with tracheal intubation
- American Society of Anesthesiologists(ASA) physical status classification I-III
Who cannot join
- pneumothorax
- room air saturation by pulse oximeter saturation less than 96%
- vocal cord palsy
- craniofacial anomaly
- congenital upper airway anomaly
- upper airway disease
Show all 10Show fewer
- cervical spine pathology
- head and neck tumor status post radiotherapy
- an increased risk of regurgitation or pulmonary aspiration
- a history of difficult tracheal intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Neutral Head Position" and "Head-lift Position" for Orotrachwal Intubation With "Trachway" Intubating Stylet in Adults
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.
Read the 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.
- Conditions
- Intubation; Difficult
- Being tested
- Head-lift position, 7cm high pillow
- Keywords
- intubating stylet, head and neck position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head-lift positionProcedure or surgery
A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.
7cm high pillowDevice
A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Head-lift position; Device: 7cm high pillow |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts
Secondary outcomes (3)
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.
Measured: during intubation, after epiglottis was identified on the video monitor
Mean Arterial Pressure
compare the mean arterial pressure between two groups.
Measured: 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.
Measured: after anesthesia emergence 30 minutest, at post-anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startDec 2014
- Primary completionOct 2015
- Study completionOct 2015
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 Intubation; DifficultStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Hung Chan, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578992
- Sponsor's protocol ID
- 2-103-05-125
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2015
- Last updated
- 9 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Neutral Head Position" and "Head-lift Position" for Orotrachwal Intubation With "Trachway" Intubating Stylet in Adults
- ClinicalTrials.gov ID
- NCT02578992
- Acronym / sponsor ID
- 2-103-05-125
- Conditions
- Intubation; Difficult
- Keywords
- intubating stylet, head and neck position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Posted 9 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head-lift Position | Experimental | Procedure: Head-lift position, Device: 7cm high pillowThe 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients scheduled for various surgeries requiring general anesthesia with tracheal intubation
- American Society of Anesthesiologists(ASA) physical status classification I-III
Key exclusion criteria (10 listed)
- pneumothorax
- room air saturation by pulse oximeter saturation less than 96%
- vocal cord palsy
- craniofacial anomaly
- congenital upper airway anomaly
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 |
|---|---|---|
| Head-lift positionA 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation. | Procedure or surgery | Head-lift Position |
| 7cm high pillowA 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation. | Device | Head-lift Position |
Primary outcome
Intubation Time
Time frame: 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.
3 secondary outcomes
Modified Cormack-Lehane Grade
Time frame: during intubation, after epiglottis was identified on the video monitor
Mean Arterial Pressure
Time frame: before and after intubation, up to 5 minutes
Visual Analog Scale of Sore Throat
Time frame: after anesthesia emergence 30 minutest, at post-anesthesia care unit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head-lift position and 7cm high pillow in people with Intubation; Difficult, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. 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: finished, as of the sponsor's last update on 9 Dec 2016. 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 Taiwan. 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 9 Dec 2016). 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 (time frame: from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts). 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 9 Dec 2016.