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

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 Overview

• Status: Completed
• Conditions: High-Flow Nasal Cannula Therapy
• Intervention / Treatment: Device: Standard care alone; Device: the modified pressure-reducing fixation protective nasal strip

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Wuxi, Jiangsu, China, 214000
      • Wuxi Ninth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: The control group; The control group received standard care plus a hydrocolloid dressing for protection	Device: Standard care alone; standard care plus a hydrocolloid dressing for protection
Other: The observation group; The observation group employed the modified pressure-reducing fixation protective nasal strip	Device: the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interval Time for Changing the Fixation Strap		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		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:	The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.
Incidence of Ineffective Oxygenation		The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.

Other Outcome Measures

Outcome Measure	Time Frame
Gender	The time from admission to discharge. up to 6 weeks.
Age	The time from admission to discharge. up to 6 weeks.
Length of hospital stay	The time from admission to discharge. up to 6 weeks.
Days of treatment use	The time from admission to discharge. up to 6 weeks.

Collaborators and Investigators

• Sponsor: Ying Zhou

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): September 15, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Estimated): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: HFNC; patient comfort; pressure ulcer; Modified Pressure-Reducing Fixation Protective Nasal Strip; nursing efficacy
• Other Study ID Numbers: KS2024035

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No