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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| novel tracheostomy bi-ties | Experimental | those with the novel tracheostomy bi-ties |
|
| traditional tracheostomy tie | Active Comparator | those with traditional tracheostomy tie |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| novel tracheostomy bi-ties | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 14days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Binquan Wang | The First Affiliated Hospital of Shanxi Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030000 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Novel Tracheostomy Bi-ties | those with the novel tracheostomy bi-ties novel tracheostomy bi-ties: 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. |
| FG001 | Traditional Tracheostomy Tie | those with traditional tracheostomy tie traditional Tracheostomy ties: Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Novel Tracheostomy Bi-ties | those with the novel tracheostomy bi-ties novel tracheostomy bi-ties: 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | 14days |
|
14 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Novel Tracheostomy Bi-ties | those with the novel tracheostomy bi-ties novel tracheostomy bi-ties: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Jun Tian | The First Hospital of Shanxi Medical University | +8618612270351 | zguotian@126.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2016 | Aug 22, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 1, 2020 | Oct 4, 2021 | ICF_001.pdf |
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| traditional Tracheostomy ties | Device | Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands. |
|
| 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 | 14days |
| Traditional Tracheostomy Tie |
those with traditional tracheostomy tie traditional Tracheostomy ties: Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Traditional Tracheostomy Tie |
those with traditional tracheostomy tie traditional Tracheostomy ties: Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands. |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 14days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 14days |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | Times | 14days |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Traditional Tracheostomy Tie | those with traditional tracheostomy tie traditional Tracheostomy ties: Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Moderate |
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| Severe |
|