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The Application Effect of Modified Pressure-Reducing Fixation Protective Nasal Strip in the Nursing Care of Patients Receiving High-Flow Nasal Cannula Therapy

The Application Effect of Modified Pressure-Reducing Fixation Protective Nasal Strip in the Nursing Care of Patients Receiving High-Flow Nasal Cannula Therapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06720129
Acronym
HFNC; pressure
Enrollment
60
Registered
2024-12-06
Start date
2024-01-01
Completion date
2024-10-01
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-Flow Nasal Cannula Therapy

Keywords

HFNC, pressure ulcer, patient comfort, Modified Pressure-Reducing Fixation Protective Nasal Strip, nursing efficacy

Brief 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 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.

Interventions

DEVICEthe modified pressure-reducing fixation protective nasal strip

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 plus a hydrocolloid dressing for protection

Sponsors

Ying Zhou
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Ineffective OxygenationThe time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.
Interval Time for Changing the Fixation StrapThe time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.
Effectiveness of skin managementThe 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:
Times of Adjusting the Catheter PositionData 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.

Secondary

MeasureTime frameDescription
Adverse Event IncidenceThe time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.adverse events such as nasal mucosal indentation, nasal mucosal pain, nasal pressure injuries, catheter dislodgement, and medical adhesive-related skin injuries.
Comparison of Comfort LevelsAssessed on the 3th day after the start of the experimentPatient 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.

Other

MeasureTime frame
GenderThe time from admission to discharge. up to 6 weeks.
Days of treatment useThe time from admission to discharge. up to 6 weeks.
Length of hospital stayThe time from admission to discharge. up to 6 weeks.
AgeThe time from admission to discharge. up to 6 weeks.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026