Therapeutic Procedural ComplicationNCT02792855
Comparing the "sniffing Position" , "Simple Head Extension" and "Neutral Position"
A study testing sniffing Position(place a 7-cm cushion under head ) and Simple Head Extension(without cushion) in people with Therapeutic Procedural Complication, run by The First Hospital of Qinhuangdao at 1 site in China.
Trial summary
The simple head extension is recommended for optimization of glottic visualization during awake orotracheal intubation whith fiberoptic bronchoscope (FOB) . However, no study to date has confirmed its superiority over "sniffing position" . Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Procedural Complication
- What is being tested?
- sniffing Position(place a 7-cm cushion under head ) and Simple Head Extension(without cushion)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2017to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI greater than 30 kg/m2
- ASA classifications of I-II, modified Mallampati classification of 3 or 4, requiring general anesthesia were included.
Who cannot join
- ASA class IV or V
- Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study Comparing the "sniffing Position" , "Simple Head Extension" and "Neutral Position" for Awake Orotracheal Intubation With Fiberoptic in Anticipate Difficult Airway Patients
The simple head extension is recommended for optimization of glottic visualization during awake orotracheal intubation whith fiberoptic bronchoscope (FOB) . However, no study to date has confirmed its superiority over "sniffing position" . In a prospective, randomized study, the authors compared the sniffing position , simple head extension and "Neutral Position" in awake orotracheal Intubation.
Read the detailed description
The study included seventy-five patients with anticipated difficult airways. The sniffing position was obtained by placement of a 7-cm cushion under the head of the patient. The extension head position was obtained by by placement of a 7-cm cushion under the shoulder.
The head position was randomized as follows: neutral position group (NP group), sniffing position group (SP group) or extension position group (EP group) Randomization was performed by placing index cards with the letter NP or SP or EP into75 sealed envelopes , which were then placed in random order. At the time of a patient's enrollment, the next available envelope was placed with the patient's chart. At the time of intubation, the envelope was opened and the sequence was thus determined.
- Conditions
- Therapeutic Procedural Complication
- Being tested
- sniffing Position(place a 7-cm cushion under head ), Simple Head Extension(without cushion)
- Keywords
- Sniffing Position, Simple Head Extension, neutral position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sniffing Position(place a 7-cm cushion under head )Device
Awake fiberoptic bronchoscope(FOB) orotracheal under sniffing position.The sniffing position was obtained by placement of a 7-cm cushion under the head of the patient. When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB
Simple Head Extension(without cushion)Device
Awake fiberoptic bronchoscope(FOB) orotracheal under Head Extension position.The Head Extension position was obtained by simple head extension.When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB
| Study group | Role | What they receive |
|---|---|---|
| sniffing Position | Experimental | Awake fiberoptic bronchoscope(FOB) orotracheal under sniffing position.The sniffing position was obtained by placement of a 7-cm cushion under the head of the patient. When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB Receives: Device: sniffing Position(place a 7-cm cushion under head ) |
| Simple Head Extension | Experimental | Awake fiberoptic bronchoscope(FOB) orotracheal under Head Extension position.The Head Extension position was obtained by simple head extension.When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB Receives: Device: Simple Head Extension(without cushion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Time
The primary endpoints were the time to view the vocal cords (TVC) which was taken when the operator indicated verbally that he view the vocal cords and the time to successful tracheal intubation (TSI). TSI was defined as the time taken from insertion of the FOB between the teeth until the appearance of a capnograhy curve.
Measured: Ten minutes
Secondary outcomes (1)
Occurrence of throat pain measured by VAS
Measured: one day Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start15 Jun 2017
- Primary completion22 Jun 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Therapeutic Procedural ComplicationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Qinhuangdao
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ximing Qi, Study director, The First Hospital of Qinhuangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792855
- Sponsor's protocol ID
- 9958
- Status last verified
- Nov 2020
- First submitted
- 31 May 2016
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Liu Z, Zhao L, Ma Z, Liu M, Qi X, Jia Q, Liang S, Yang X. Effects of head positions on awake fiberoptic bronchoscope oral intubation: a randomized controlled trial. BMC Anesthesiol. 2021 Jun 23;21(1):176. doi: 10.1186/s12871-021-01397-4.
PubMed 34162330
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing the "sniffing Position" , "Simple Head Extension" and "Neutral Position" for Awake Orotracheal Intubation With Fiberoptic in Anticipate Difficult Airway Patients
- ClinicalTrials.gov ID
- NCT02792855
- Acronym / sponsor ID
- 9958
- Conditions
- Therapeutic Procedural Complication
- Keywords
- Sniffing Position, Simple Head Extension, neutral position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 22 Jun 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The simple head extension is recommended for optimization of glottic visualization during awake orotracheal intubation whith fiberoptic bronchoscope (FOB) . However, no study to date has confirmed its superiority over "sniffing position" . In a prospective, randomized study, the authors compared the sniffing position , simple head extension and "Neutral Position" in awake orotracheal Intubation.
Detailed description
The study included seventy-five patients with anticipated difficult airways. The sniffing position was obtained by placement of a 7-cm cushion under the head of the patient. The extension head position was obtained by by placement of a 7-cm cushion under the shoulder.
The head position was randomized as follows: neutral position group (NP group), sniffing position group (SP group) or extension position group (EP group) Randomization was performed by placing index cards with the letter NP or SP or EP into75 sealed envelopes , which were then placed in random order. At the time of a patient's enrollment, the next available envelope was placed with the patient's chart. At the time of intubation, the envelope was opened and the sequence was thus determined.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sniffing Position | Experimental | Device: sniffing Position(place a 7-cm cushion under head )Awake fiberoptic bronchoscope(FOB) orotracheal under sniffing position.The sniffing position was obtained by placement of a 7-cm cushion under the head of the patient. When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB |
| Simple Head Extension | Experimental | Device: Simple Head Extension(without cushion)Awake fiberoptic bronchoscope(FOB) orotracheal under Head Extension position.The Head Extension position was obtained by simple head extension.When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI greater than 30 kg/m2
- ASA classifications of I-II, modified Mallampati classification of 3 or 4, requiring general anesthesia were included.
Key exclusion criteria (2 listed)
- ASA class IV or V
- Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions
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 |
|---|---|---|
| sniffing Position(place a 7-cm cushion under head )Awake fiberoptic bronchoscope(FOB) orotracheal under sniffing position.The sniffing position was obtained by placement of a 7-cm cushion under the head of the patient. When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB | Device | sniffing Position |
| Simple Head Extension(without cushion)Awake fiberoptic bronchoscope(FOB) orotracheal under Head Extension position.The Head Extension position was obtained by simple head extension.When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB | Device | Simple Head Extension |
Primary outcome
Intubation Time
Time frame: Ten minutes
The primary endpoints were the time to view the vocal cords (TVC) which was taken when the operator indicated verbally that he view the vocal cords and the time to successful tracheal intubation (TSI). TSI was defined as the time taken from insertion of the FOB between the teeth until the appearance of a capnograhy curve.
1 secondary outcome
Occurrence of throat pain measured by VAS
Time frame: one day Postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Derived from this study: PubMed 34162330Liu Z, Zhao L, Ma Z, Liu M, Qi X, Jia Q, Liang S, Yang X. Effects of head positions on awake fiberoptic bronchoscope oral intubation: a randomized controlled trial. BMC Anesthesiol. 2021 Jun 23;21(1):176. doi: 10.1186/s12871-021-01397-4.
- Individual participant dataSharing planned: Yes
Related trials for Therapeutic Procedural Complication
Enrolling by invitation
Immersive Visual Modulation and Ambient Music Therapy During Transvaginal Ultrasonography in Women With Vaginismus
Vaginismus
Recruiting
Cervical Preparation for Same-Day Dilation & Evacuation
Abortion, Second Trimester, Procedural Pain
RecruitingPhase 4
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
Urinary Bladder, Overactive, Incontinence, Urge
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.
Ximing Qi study director
The First Hospital of Qinhuangdao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sniffing Position(place a 7-cm cushion under head ) and Simple Head Extension(without cushion) in people with Therapeutic Procedural Complication, run by The First Hospital of Qinhuangdao at 1 site in China.
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 2 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 11 Apr 2022. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Ten minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02792855, which also lists 1 linked publication.
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 11 Apr 2022.