Prone CraniotomyTransNCT05093595
the Effect of Trans-nasal Fixation of Endotracheal Tubes for Prone Ventilation
A study testing SFC in people with Prone Craniotomy and Endotracheal Intubation Fixation, run by China Medical University, China at 1 site in China.
Trial summary
The aim of this randomized controlled trial is to evaluate the clinical effects of trans-nasal ETT fixation for prone ventilation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Prone Craniotomy, Endotracheal Intubation Fixation
- What is being tested?
- SFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2021to 25 Jan 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-60 years old,
- ASA grade Ⅰ-Ⅱ,
- 18<BMI<24.
Who cannot join
- the intubation time was less than 5 hours,
- oral and facial skin damage,
- allergic to adhensive tapes,
- nasotracheal intubation,
- patients were edentulous.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trans-nasal ETT Fixation
The aim of this randomized controlled trial is to evaluate the clinical effects of trans-nasal ETT fixation for prone ventilation.
- Conditions
- Prone Craniotomy, Endotracheal Intubation Fixation
- Being tested
- SFC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFCDevice
The lubricated SFC passed nasally into the oropharynx under the visual guidance of visual laryngoscope to ensure that the cuff had passed through the posterior choanae and reached the oropharynx. The guide wire is removed and the balloon inflated with 5 ml normal saline. The catheter is then pulled slightly until the balloon is fixed and concealed by the soft palate . The ETT is anchored to the SFC with a cable tie .
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | The tracheal tube was routinely fixed with a teeth pad and adhesive tape (3M). |
| Group B | Experimental | The tracheal tube was fixed by the trans-nasal Silicone Foley Catheter (SFC) and adhesive tape. Receives: Device: SFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
the distance of tube movement
It is the difference between the preoperative depth of the supine tracheal tube and the postoperative depth of the prone tracheal tube.
Measured: The participants will be followed from intubation to extubation, an expected average of 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start27 Oct 2021
- Primary completion27 Dec 2021
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prone CraniotomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yue Yun, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093595
- Sponsor's protocol ID
- 2019
- Acronym
- Trans
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 8 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-nasal ETT Fixation
- ClinicalTrials.gov ID
- NCT05093595
- Acronym / sponsor ID
- Trans / 2019
- Conditions
- Prone Craniotomy, Endotracheal Intubation Fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 26 Oct 2021 (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 aim of this randomized controlled trial is to evaluate the clinical effects of trans-nasal ETT fixation for prone ventilation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –The tracheal tube was routinely fixed with a teeth pad and adhesive tape (3M). |
| Group B | Experimental | Device: SFCThe tracheal tube was fixed by the trans-nasal Silicone Foley Catheter (SFC) and adhesive tape. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18-60 years old,
- ASA grade Ⅰ-Ⅱ,
- 18<BMI<24.
Key exclusion criteria (5 listed)
- the intubation time was less than 5 hours,
- oral and facial skin damage,
- allergic to adhensive tapes,
- nasotracheal intubation,
- patients were edentulous.
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 |
|---|---|---|
| SFCThe lubricated SFC passed nasally into the oropharynx under the visual guidance of visual laryngoscope to ensure that the cuff had passed through the posterior choanae and reached the oropharynx. The guide wire is removed and the balloon inflated with 5 ml normal saline. The catheter is then pulled slightly until the balloon is fixed and concealed by the soft palate . The ETT is anchored to the SFC with a cable tie . | Device | Group B |
Primary outcome
the distance of tube movement
Time frame: The participants will be followed from intubation to extubation, an expected average of 6 hours.
It is the difference between the preoperative depth of the supine tracheal tube and the postoperative depth of the prone tracheal tube.
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 8 Mar 2022.
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 SFC in people with Prone Craniotomy and Endotracheal Intubation Fixation, run by China Medical University, China 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 3 inclusion and 5 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 8 Mar 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?
the distance of tube movement (time frame: The participants will be followed from intubation to extubation, an expected average of 6 hours.). 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 8 Mar 2022.