Tracheostomy Complication
Conditions
Keywords
tracheostomy ties
Brief 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. 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.
Interventions
DEVICEnovel 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.
DEVICEtraditional Tracheostomy ties
Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands.
Sponsors
The First Affiliated Hospital of Shanxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects ≥ 18 years old and ≤ 60 years old; 2. Patients with a tracheostomy; 3. With intact neck skin; 4. Willingly signs the Informed Consent; 5. Is qualified to participate in the opinion of the Investigator; 6. Without disorders of consciousness.
Exclusion criteria
1. 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; 2. With damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site; 3. Has a known or stated allergy to adhesive bandages, or any of the product types being tested; 4. Uses of topical drugs on the application site; 5. Uses lotions, creams or oils on the application site; 6. Can not communicate with nurses or doctors for any reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale of Comfort of Patients During Wearing or Exchanging Tracheostomy Ties (0-10) Higher Scores Mean Worse Outcome. | 14days | 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. |
| Objective Index:the Actually Frequency of Exchanging Dressing | 14days | The record of the frequency of exchanging dressing under the tracheostomy ties in practice will be collected |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Traditional Tracheostomy Tie | Total | Novel Tracheostomy Bi-ties |
|---|---|---|---|
| Age, Continuous | 53.0 years STANDARD_DEVIATION 5.5 | 53.7 years STANDARD_DEVIATION 4.8 | 55.1 years STANDARD_DEVIATION 2.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 60 Participants | 30 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 29 Participants | 57 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: 14days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Novel Tracheostomy Bi-ties | Number of Participants With Local Skin Breakdown | None | 30 Participants |
| Novel Tracheostomy Bi-ties | Number of Participants With Local Skin Breakdown | Mild | 0 Participants |
| Novel Tracheostomy Bi-ties | Number of Participants With Local Skin Breakdown | Moderate | 0 Participants |
| Novel Tracheostomy Bi-ties | Number of Participants With Local Skin Breakdown | Severe | 0 Participants |
| Traditional Tracheostomy Tie | Number of Participants With Local Skin Breakdown | Severe | 0 Participants |
| Traditional Tracheostomy Tie | Number of Participants With Local Skin Breakdown | None | 27 Participants |
| Traditional Tracheostomy Tie | Number of Participants With Local Skin Breakdown | Moderate | 1 Participants |
| Traditional Tracheostomy Tie | Number of Participants With Local Skin Breakdown | Mild | 2 Participants |
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
Time frame: 14days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Novel Tracheostomy Bi-ties | Visual Analogue Scale to Measure the Difficulty Level of Exchanging or Cleaning the Tracheostomy Ties (0 to 10 ) Higher Scores Mean a Worse Outcome | 1.2 score on a scale | Standard Deviation 0.6 |
| Traditional Tracheostomy Tie | Visual Analogue Scale to Measure the Difficulty Level of Exchanging or Cleaning the Tracheostomy Ties (0 to 10 ) Higher Scores Mean a Worse Outcome | 7.5 score on a scale | Standard Deviation 0.5 |
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
Time frame: 14days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Novel Tracheostomy Bi-ties | Objective Index:the Actually Frequency of Exchanging Dressing | 0 Times | Standard Deviation 0 |
| Traditional Tracheostomy Tie | Objective Index:the Actually Frequency of Exchanging Dressing | 2 Times | Standard Deviation 0.64 |
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.
Time frame: 14days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Novel Tracheostomy Bi-ties | Visual Analogue Scale of Comfort of Patients During Wearing or Exchanging Tracheostomy Ties (0-10) Higher Scores Mean Worse Outcome. | 1.0 units on a scale | Standard Deviation 0.7 |
| Traditional Tracheostomy Tie | Visual Analogue Scale of Comfort of Patients During Wearing or Exchanging Tracheostomy Ties (0-10) Higher Scores Mean Worse Outcome. | 8.9 units on a scale | Standard Deviation 0.8 |