Therapeutic Procedural ComplicationNCT05331287
Comparing the "Snifing Position" , "Simple Head Extension" and "Neutral Position"
A study testing Head position 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 Nasotracheal intubation via fiberoptic bronchoscope (FOB) . However, no study confirmed its superiority over"snifing position" and "Neutral Position". Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Therapeutic Procedural Complication
- What is being tested?
- Head position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2022to 30 Aug 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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: First Hospital of Qinhuangdao，Hebei Province, China
The simple head extension is recommended for optimization of glottic visualization during Nasotracheal intubation via fiberoptic bronchoscope (FOB) . However, no study confirmed its superiority over"snifing position" and "Neutral Position". In a prospective, randomized study, the authors compared the snifing position , simple head extension and "Neutral Position" in Nasotracheal intubation via fiberoptic bronchoscope.
Read the detailed description
The study included ninety patients with anticipated difficult airways. The snifing position was obtained by placement of a 7-cm cushion under the head of the patient; the extension head position was obtained by placement of a 7-cm cushion under the shoulder; the neutral position with the occiput close to the operating table. The head position was randomized as follows: neutral position group (NP group), sniffing position group (SP group) or extension position group (EP group). Randomization (1:1:1) was based on the codes generated by Excel software, which were kept in sequentially numbered opaque envelopes until the began of study.
- Conditions
- Therapeutic Procedural Complication
- Being tested
- Head position
- Keywords
- Snifing Position, Simple Head Extension, neutral position, Nasotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head positionOther
Influence of different head position on nasal endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| snifing Position | Experimental | Nasotracheal intubation via fiberoptic bronchoscope under snifing position.The snifing position was obtained by placement of a 7-cm cushion under the head of the patient. When the FOB was inserted into Nasal 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: Other: Head position |
| neutral position | Experimental | Nasotracheal intubation via fiberoptic bronchoscope under snifing position.The Head Extension was obtained by the occiput of the patient close to the operating table. When the FOB was inserted into Nasal 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: Other: Head position |
| Head Extension | Experimental | Nasotracheal intubation via fiberoptic bronchoscope under snifing position.The extension position with a 7-cm pillow underneath the shoulder and the occiput close to the operating table. When the FOB was inserted into Nasal 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: Other: Head position |
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 posted15 Apr 2022
- Study start20 Apr 2022
- Primary completion30 Jun 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Qinhuangdao
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331287
- Sponsor's protocol ID
- 5866
- Status last verified
- Feb 2023
- First submitted
- 27 Mar 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Hospital of Qinhuangdao，Hebei Province, China
- ClinicalTrials.gov ID
- NCT05331287
- Acronym / sponsor ID
- 5866
- Conditions
- Therapeutic Procedural Complication
- Keywords
- Snifing Position, Simple Head Extension, neutral position, Nasotracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 15 Apr 2022 (actual)
- 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 Nasotracheal intubation via fiberoptic bronchoscope (FOB) . However, no study confirmed its superiority over"snifing position" and "Neutral Position". In a prospective, randomized study, the authors compared the snifing position , simple head extension and "Neutral Position" in Nasotracheal intubation via fiberoptic bronchoscope.
Detailed description
The study included ninety patients with anticipated difficult airways. The snifing position was obtained by placement of a 7-cm cushion under the head of the patient; the extension head position was obtained by placement of a 7-cm cushion under the shoulder; the neutral position with the occiput close to the operating table. The head position was randomized as follows: neutral position group (NP group), sniffing position group (SP group) or extension position group (EP group). Randomization (1:1:1) was based on the codes generated by Excel software, which were kept in sequentially numbered opaque envelopes until the began of study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| snifing Position | Experimental | Other: Head positionNasotracheal intubation via fiberoptic bronchoscope under snifing position.The snifing position was obtained by placement of a 7-cm cushion under the head of the patient. When the FOB was inserted into Nasal 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. |
| neutral position | Experimental | Other: Head positionNasotracheal intubation via fiberoptic bronchoscope under snifing position.The Head Extension was obtained by the occiput of the patient close to the operating table. When the FOB was inserted into Nasal 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. |
| Head Extension | Experimental | Other: Head positionNasotracheal intubation via fiberoptic bronchoscope under snifing position.The extension position with a 7-cm pillow underneath the shoulder and the occiput close to the operating table. When the FOB was inserted into Nasal 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
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 positionInfluence of different head position on nasal endotracheal intubation | Other | Head Extension, neutral position, snifing Position |
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 15 Feb 2023.
- Individual participant dataSharing planned: No
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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 position 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 1 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 15 Feb 2023. 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?
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 15 Feb 2023.