High-Flow Nasal Cannula TherapyHFNC; pressureNCT06720129
The Application Effect of Modified Pressure-Reducing Fixation Protective Nasal Strip in the Nursing Care of Patients Receiving High-Flow Nasal Cannula Therapy
A study testing the modified pressure-reducing fixation protective nasal strip in people with High-Flow Nasal Cannula Therapy, run by Ying Zhou at 1 site in China.
Trial summary
This study was a prospective, randomized controlled trial that included 60 patients receiving high-flow nasal cannula (HFNC) therapy. Participants were randomly divided into two groups: the observation group (n=30), which used a modified decompression fixation protective patch, and the control group (n=30), which… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- High-Flow Nasal Cannula Therapy
- What is being tested?
- the modified pressure-reducing fixation protective nasal strip
- 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 Jan 2024to 1 Oct 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Meet the diagnostic criteria for respiratory failure, worsening dyspnea, acute exacerbation of chronic obstructive pulmonary disease (COPD), bronchitis, pneumonia, and congestive heart failure.
- 2. No severe cognitive impairment.
- 3. Good compliance and being able to actively cooperate with the investigation.
- 4. No concurrent metabolic diseases.
Who cannot join
- 1. Patients with severe respiratory failure, severe arrhythmias, concurrent pneumothorax, coma upon admission, or persistent vomiting.
- 2. Patients with severe liver failure, kidney failure, or other severe systemic diseases.
- 3. Patients with severe cognitive impairment who are unable to understand or comply with the study requirements.
- 4. Patients with severe hemodynamic instability.
- 5. Patients with allergies to oxygen therapy or protective patch materials.
Trial locations and contacts
1 site in 1 country.
About this study
This study was a prospective, randomized controlled trial that included 60 patients receiving high-flow nasal cannula (HFNC) therapy. Participants were randomly divided into two groups: the observation group (n=30), which used a modified decompression fixation protective patch, and the control group (n=30), which received hydrocolloid dressing protection in addition to standard care. The study compared general demographic data, the interval time between changing fixation straps, the times of adjusting the catheter position, the effectiveness of skin management, the number of ineffective oxygenation attempts, the incidence of adverse events, and patient comfort scores between the two groups.
- Conditions
- High-Flow Nasal Cannula Therapy
- Being tested
- the modified pressure-reducing fixation protective nasal strip, Standard care alone
- Keywords
- HFNC, pressure ulcer, patient comfort, Modified Pressure-Reducing Fixation Protective Nasal Strip, nursing efficacy
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the modified pressure-reducing fixation protective nasal stripDevice
Materials Preparation consists of one foam dressing, one piece of 3M tape, and two pairs of scissors. 2. Manufacturing Procedure: step 1 Cut the foam dressing into two large rectangles and one little T-shape based on the patient's face shape and size as well as the width of the nasolabial fold. Attach these sections to the nasolabial fold region and both cheeks, respectively . Step 2: Based on the size of the oxygen cannula, set up small, medium, and large fixation patch models. Select the appropriate model according to the patient's condition and make the necessary cuts to properly secure the nasal prongs. Step 3: Check the tightness of the head strap, ensuring it is snug enough to fit one finger beneath it to avoid pressing on the skin around the ears. Ensure proper placement on the patient. See Figure 1 for detailed application.
Standard care aloneDevice
standard care plus a hydrocolloid dressing for protection
| Study group | Role | What they receive |
|---|---|---|
| The control group | Other | The control group received standard care plus a hydrocolloid dressing for protection Receives: Device: Standard care alone |
| The observation group | Other | The observation group employed the modified pressure-reducing fixation protective nasal strip Receives: Device: the modified pressure-reducing fixation protective nasal strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interval Time for Changing the Fixation Strap
Measured: The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.
Times of Adjusting the Catheter Position
Measured: Data were collected every three days from the initiation of high-flow nasal cannula (HFNC) therapy until its removal as per medical advice. up to a month.
Effectiveness of skin management
The Braden Scale assesses six factors to determine a patient's risk of developing pressure ulcers. Each factor is scored from 1 to 4 (except for activity and friction/shear, which are scored from 1 to 3), with a total possible score of 23. The lower the total score, the higher the risk of pressure ulcers. (Sensory Perception: Assesses the patient's ability to perceive and respond to discomfort or pressure on the skin; Normal sensation: 4 points. Completely unable to sense: 1 point. Moisture: Evaluates the frequency of skin exposure to moisture. Skin stays dry: 4 points; Skin is often moist: 1 point. Activity: Assesses the patient's ability to move. Fully mobile: 4 points; Completely bedridden: 1 point. Mobility: Evaluates the patient's ability to change and control body position. Fully able to move and control: 4 points; Completely unable to move: 1 point. Nutrition: Assesses the patient's nutritional intake. Good nutrition: 4 points; Very poor nutrition: 1 point. Friction and Shear:
Measured: The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.
Incidence of Ineffective Oxygenation
Measured: The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.
Secondary outcomes (2)
Comparison of Comfort Levels
Patient comfort is assessed on the 3th day after the start of the experiment. The scale includes 4 dimensions with 30 items, scored from 30 to 120. Higher scores indicate greater comfort. Total score < 60: Low comfort; Score 60-90: Moderate comfort; Score > 90: High comfort.
Measured: Assessed on the 3th day after the start of the experiment
Adverse Event Incidence
adverse events such as nasal mucosal indentation, nasal mucosal pain, nasal pressure injuries, catheter dislodgement, and medical adhesive-related skin injuries.
Measured: The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Jan 2024
- Primary completion15 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Flow Nasal Cannula TherapyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ying Zhou
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ying Zhou, Wuxi Ninth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720129
- Sponsor's protocol ID
- KS2024035
- Acronym
- HFNC; pressure
- Status last verified
- Dec 2024
- First submitted
- 21 Nov 2024
- Last updated
- 6 Dec 2024
- 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application Effect of Modified Pressure-Reducing Fixation Protective Nasal Strip in the Nursing Care of Patients Receiving High-Flow Nasal Cannula Therapy
- ClinicalTrials.gov ID
- NCT06720129
- Acronym / sponsor ID
- HFNC; pressure / KS2024035
- Conditions
- High-Flow Nasal Cannula Therapy
- Keywords
- HFNC, pressure ulcer, patient comfort, Modified Pressure-Reducing Fixation Protective Nasal Strip, nursing efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ying ZhouOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 6 Dec 2024 (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.
This study was a prospective, randomized controlled trial that included 60 patients receiving high-flow nasal cannula (HFNC) therapy. Participants were randomly divided into two groups: the observation group (n=30), which used a modified decompression fixation protective patch, and the control group (n=30), which received hydrocolloid dressing protection in addition to standard care. The study compared general demographic data, the interval time between changing fixation straps, the times of adjusting the catheter position, the effectiveness of skin management, the number of ineffective oxygenation attempts, the incidence of adverse events, and patient comfort scores between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | Other | Device: Standard care aloneThe control group received standard care plus a hydrocolloid dressing for protection |
| The observation group | Other | Device: the modified pressure-reducing fixation protective nasal stripThe observation group employed the modified pressure-reducing fixation protective nasal strip |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Meet the diagnostic criteria for respiratory failure, worsening dyspnea, acute exacerbation of chronic obstructive pulmonary disease (COPD), bronchitis, pneumonia, and congestive heart failure.
- 2. No severe cognitive impairment.
- 3. Good compliance and being able to actively cooperate with the investigation.
- 4. No concurrent metabolic diseases.
Key exclusion criteria (5 listed)
- 1. Patients with severe respiratory failure, severe arrhythmias, concurrent pneumothorax, coma upon admission, or persistent vomiting.
- 2. Patients with severe liver failure, kidney failure, or other severe systemic diseases.
- 3. Patients with severe cognitive impairment who are unable to understand or comply with the study requirements.
- 4. Patients with severe hemodynamic instability.
- 5. Patients with allergies to oxygen therapy or protective patch materials.
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 |
|---|---|---|
| the modified pressure-reducing fixation protective nasal stripMaterials Preparation consists of one foam dressing, one piece of 3M tape, and two pairs of scissors. 2. Manufacturing Procedure: step 1 Cut the foam dressing into two large rectangles and one little T-shape based on the patient's face shape and size as well as the width of the nasolabial fold. Attach these sections to the nasolabial fold region and both cheeks, respectively . Step 2: Based on the size of the oxygen cannula, set up small, medium, and large fixation patch models. Select the appropriate model according to the patient's condition and make the necessary cuts to properly secure the nasal prongs. Step 3: Check the tightness of the head strap, ensuring it is snug enough to fit one finger beneath it to avoid pressing on the skin around the ears. Ensure proper placement on the patient. See Figure 1 for detailed application. | Device | The observation group |
| Standard care alonestandard care plus a hydrocolloid dressing for protection | Device | The control group |
Primary outcome
Interval Time for Changing the Fixation Strap
Time frame: The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.
Times of Adjusting the Catheter Position
Time frame: Data were collected every three days from the initiation of high-flow nasal cannula (HFNC) therapy until its removal as per medical advice. up to a month.
Effectiveness of skin management
Time frame: The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.
The Braden Scale assesses six factors to determine a patient's risk of developing pressure ulcers. Each factor is scored from 1 to 4 (except for activity and friction/shear, which are scored from 1 to 3), with a total possible score of 23. The lower the total score, the higher the risk of pressure ulcers. (Sensory Perception: Assesses the patient's ability to perceive and respond to discomfort or pressure on the skin; Normal sensation: 4 points. Completely unable to sense: 1 point. Moisture: Evaluates the frequency of skin exposure to moisture. Skin stays dry: 4 points; Skin is often moist: 1 point. Activity: Assesses the patient's ability to move. Fully mobile: 4 points; Completely bedridden: 1 point. Mobility: Evaluates the patient's ability to change and control body position. Fully able to move and control: 4 points; Completely unable to move: 1 point. Nutrition: Assesses the patient's nutritional intake. Good nutrition: 4 points; Very poor nutrition: 1 point. Friction and Shear:
Incidence of Ineffective Oxygenation
Time frame: The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.
2 secondary outcomes
Comparison of Comfort Levels
Time frame: Assessed on the 3th day after the start of the experiment
Adverse Event Incidence
Time frame: The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.
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 6 Dec 2024.
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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 the modified pressure-reducing fixation protective nasal strip in people with High-Flow Nasal Cannula Therapy, run by Ying Zhou 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 4 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 6 Dec 2024. 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?
Interval Time for Changing the Fixation Strap (time frame: The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.). The study lists 4 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 6 Dec 2024.