Tracheostomy ComplicationAONTTNCT02820181
Assessment of a Novel Tracheostomy Tie
A study testing novel tracheostomy bi-ties and traditional Tracheostomy ties in people with Tracheostomy Complication, run by The First Affiliated Hospital of Shanxi Medical University at 1 site in China.
Trial summary
Tracheotomy is a common procedure for multiple medical indications.Tracheostomy tubes must be securely fixed to prevent movement or decannulation and tracheostomy ties must be exchanged as needed. However, the process of ties exchange is always risky and complicated. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tracheostomy Complication
- What is being tested?
- novel tracheostomy bi-ties and traditional Tracheostomy ties
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2016to 31 May 2019
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects ≥ 18 years old and ≤ 60 years old;
- Patients with a tracheostomy;
- With intact neck skin;
- Willingly signs the Informed Consent;
- Is qualified to participate in the opinion of the Investigator;
- Without disorders of consciousness.
Who cannot join
- With an existing neck injury or infection or clinically significant skin diseases on the application site which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, active cancer;
- With damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site;
- Has a known or stated allergy to adhesive bandages, or any of the product types being tested;
- Uses of topical drugs on the application site;
- Uses lotions, creams or oils on the application site;
- Can not communicate with nurses or doctors for any reasons
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030000
About this study
Official title: Assessment of Functionality and Performance of a Novel Tracheostomy Tie
Tracheotomy is a common procedure for multiple medical indications.Tracheostomy tubes must be securely fixed to prevent movement or decannulation and tracheostomy ties must be exchanged as needed. However, the process of ties exchange is always risky and complicated. A novel tracheostomy tie has been designed to ensure the safety during exchanging and conveniences of cleaning. This study is to determine if the new device is better than the old one.
Read the detailed description
Tracheotomy is a common procedure for multiple medical indications. Nursing staff must understand the immediate postoperative and long-term management of tracheostomy patients. To provide safe and competent care, tracheostomy tubes must be taken care of carefully, including cleaning or changing the inner cannula, caring for the stoma, suctioning at least 3 times a day, and replacing tracheostomy ties according to facility-specific policy as needed. However, to avoid inadvertent dislodgement of the tracheostomy tube, the process of ties exchange is always risky and complicated, which request one person to hold the tube in place while a second person performs the tie exchange.
The investigators designed a novel tracheostomy tie to ensure the safety during exchanging and conveniences of cleaning, the primary feature of which is double belts and easy to operate. This randomized controlled trial is to determine if the new device is better than the traditional one.
Sixty tracheotomy patients without an existing neck injury will be recruited . Patients in experimental group wear a novel tracheostomy tie. The traditional one was used in control group. Difficulty level of exchanging or cleaning the tracheostomy ties, degree of comfort, skin breakdown and the actually frequency of exchanging will be evaluated.
- Conditions
- Tracheostomy Complication
- Being tested
- novel tracheostomy bi-ties, traditional Tracheostomy ties
- Keywords
- tracheostomy ties
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel tracheostomy bi-tiesDevice
The investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate.
traditional Tracheostomy tiesDevice
Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands.
| Study group | Role | What they receive |
|---|---|---|
| novel tracheostomy bi-ties | Experimental | those with the novel tracheostomy bi-ties Receives: Device: novel tracheostomy bi-ties |
| traditional tracheostomy tie | Active comparator | those with traditional tracheostomy tie Receives: Device: traditional Tracheostomy ties |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale to Measure the Difficulty Level of Exchanging or Cleaning the Tracheostomy Ties (0 to 10 ) Higher Scores Mean a Worse Outcome
Nurses will be evaluated by Visual Analogue Scale/Score to measure the difficulty level of exchanging or cleaning the tracheostomy ties.
Title: Visual Analogue Scale to measure the difficulty level of exchanging or cleaning the tracheostomy ties (0 to 10 ) Higher scores mean a worse outcome
Measured: 14days
Number of Participants With Local Skin Breakdown
Scale for breakdown of neck skin wound was rated as mild, moderate, or severe. "Mild" wounds included fragile skin that was erythematous or had a small amount of breakdown (<1 cm in diameter). Wounds with evident skin erosion or breakdown associated with drainage and/or pain were classified as "moderate." "Severe" wounds were defined as a partial-thickness loss of dermis presenting as a shallow open ulcer with a red-pink wound bed.
Measured: 14days
Secondary outcomes (2)
Visual Analogue Scale of Comfort of Patients During Wearing or Exchanging Tracheostomy Ties (0-10) Higher Scores Mean Worse Outcome.
Visual Analogue Scale/Score will be used to measure the degree of comfort of patients during wearing or exchanging tracheostomy ties Title: Visual Analogue Scale of comfort of patients during wearing or exchanging tracheostomy ties(0-10) Higher scores mean worse outcome.
Measured: 14days
Objective Index:the Actually Frequency of Exchanging Dressing
The record of the frequency of exchanging dressing under the tracheostomy ties in practice will be collected
Measured: 14days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start1 Aug 2016
- Primary completion1 May 2019
- Study completion31 May 2019
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 Tracheostomy 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Tian, The First Affiliated Hospital of Shanxi Medical University
- Investigators
- Binquan Wang, Study director, The First Affiliated Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820181
- Sponsor's protocol ID
- FirstTianjunENT
- Acronym
- AONTT
- Status last verified
- Oct 2021
- First submitted
- 22 Jun 2016
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Functionality and Performance of a Novel Tracheostomy Tie
- ClinicalTrials.gov ID
- NCT02820181
- Acronym / sponsor ID
- AONTT / FirstTianjunENT
- Conditions
- Tracheostomy Complication
- Keywords
- tracheostomy ties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Posted 2 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tracheotomy is a common procedure for multiple medical indications.Tracheostomy tubes must be securely fixed to prevent movement or decannulation and tracheostomy ties must be exchanged as needed. However, the process of ties exchange is always risky and complicated. A novel tracheostomy tie has been designed to ensure the safety during exchanging and conveniences of cleaning. This study is to determine if the new device is better than the old one.
Detailed description
Tracheotomy is a common procedure for multiple medical indications. Nursing staff must understand the immediate postoperative and long-term management of tracheostomy patients. To provide safe and competent care, tracheostomy tubes must be taken care of carefully, including cleaning or changing the inner cannula, caring for the stoma, suctioning at least 3 times a day, and replacing tracheostomy ties according to facility-specific policy as needed. However, to avoid inadvertent dislodgement of the tracheostomy tube, the process of ties exchange is always risky and complicated, which request one person to hold the tube in place while a second person performs the tie exchange.
The investigators designed a novel tracheostomy tie to ensure the safety during exchanging and conveniences of cleaning, the primary feature of which is double belts and easy to operate. This randomized controlled trial is to determine if the new device is better than the traditional one.
Sixty tracheotomy patients without an existing neck injury will be recruited . Patients in experimental group wear a novel tracheostomy tie. The traditional one was used in control group. Difficulty level of exchanging or cleaning the tracheostomy ties, degree of comfort, skin breakdown and the actually frequency of exchanging will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| novel tracheostomy bi-ties | Experimental | Device: novel tracheostomy bi-tiesthose with the novel tracheostomy bi-ties |
| traditional tracheostomy tie | Active comparator | Device: traditional Tracheostomy tiesthose with traditional tracheostomy tie |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects ≥ 18 years old and ≤ 60 years old;
- Patients with a tracheostomy;
- With intact neck skin;
- Willingly signs the Informed Consent;
- Is qualified to participate in the opinion of the Investigator;
Key exclusion criteria (6 listed)
- With an existing neck injury or infection or clinically significant skin diseases on the application site which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, active cancer;
- With damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site;
- Has a known or stated allergy to adhesive bandages, or any of the product types being tested;
- Uses of topical drugs on the application site;
- Uses lotions, creams or oils on the application site;
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 |
|---|---|---|
| novel tracheostomy bi-tiesThe investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate. | Device | novel tracheostomy bi-ties |
| traditional Tracheostomy tiesTraditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands. | Device | traditional tracheostomy tie |
Primary outcome
Visual Analogue Scale to Measure the Difficulty Level of Exchanging or Cleaning the Tracheostomy Ties (0 to 10 ) Higher Scores Mean a Worse Outcome
Time frame: 14days
Nurses will be evaluated by Visual Analogue Scale/Score to measure the difficulty level of exchanging or cleaning the tracheostomy ties. Title: Visual Analogue Scale to measure the difficulty level of exchanging or cleaning the tracheostomy ties (0 to 10 ) Higher scores mean a worse outcome
Number of Participants With Local Skin Breakdown
Time frame: 14days
Scale for breakdown of neck skin wound was rated as mild, moderate, or severe. "Mild" wounds included fragile skin that was erythematous or had a small amount of breakdown (<1 cm in diameter). Wounds with evident skin erosion or breakdown associated with drainage and/or pain were classified as "moderate." "Severe" wounds were defined as a partial-thickness loss of dermis presenting as a shallow open ulcer with a red-pink wound bed.
2 secondary outcomes
Visual Analogue Scale of Comfort of Patients During Wearing or Exchanging Tracheostomy Ties (0-10) Higher Scores Mean Worse Outcome.
Time frame: 14days
Objective Index:the Actually Frequency of Exchanging Dressing
Time frame: 14days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Tracheostomy Complication
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Increased Body Temperature Post Tracheostomy: a Retrospective Study
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Outcomes After Tracheal Cannula Removal
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Complications Related to the Anaesthesia During Airway Endoscopy in Children With Tracheostomy.
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"Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Serve as Predictors for Airway Complications Confirmed Through Surveillance Endoscopy?"
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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.
Binquan Wang study director
The First Affiliated Hospital of Shanxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing novel tracheostomy bi-ties and traditional Tracheostomy ties in people with Tracheostomy Complication, run by The First Affiliated Hospital of Shanxi Medical University 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 6 inclusion and 6 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 2 Nov 2021. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2021). 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?
Visual Analogue Scale to Measure the Difficulty Level of Exchanging or Cleaning the Tracheostomy Ties (0 to 10 ) Higher Scores Mean a Worse Outcome (time frame: 14days). The study lists 2 primary outcomes in all. 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 2 Nov 2021.