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Completed

NCT Number: NCT06720129

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

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.

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Key information

Conditions

High-Flow Nasal Cannula Therapy Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuxi Ninth People's Hospital

Wuxi, Jiangsu, 214000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

the modified pressure-reducing fixation protective nasal strip

Device

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 alone

Device

standard care plus a hydrocolloid dressing for protection

Primary outcomes

  1. 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.

  2. 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.

  3. 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:

  4. 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.

Secondary outcomes

  1. Comparison of Comfort Levels

    Time frame: Assessed on the 3th day after the start of the experiment

    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.

  2. 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.

    adverse events such as nasal mucosal indentation, nasal mucosal pain, nasal pressure injuries, catheter dislodgement, and medical adhesive-related skin injuries.

Other outcomes

  1. Gender

    Time frame: The time from admission to discharge. up to 6 weeks.

  2. Age

    Time frame: The time from admission to discharge. up to 6 weeks.

  3. Length of hospital stay

    Time frame: The time from admission to discharge. up to 6 weeks.

  4. Days of treatment use

    Time frame: The time from admission to discharge. up to 6 weeks.

Sponsors and collaborators

Lead sponsor

Ying Zhou

Other Gov

Registry information

Acronym: HFNC; pressure

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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