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

NCT06720129 | Completed

• 1 other identifier: KS2024035
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

High-Flow Nasal Cannula Therapy

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Comparison of Comfort Levels

  Assessed on the 3th day after the start of the experiment

• Adverse Event Incidence

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

Other Outcomes (4)

• 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.

Study Arms (2)

The control group

OTHER

The control group received standard care plus a hydrocolloid dressing for protection

Device: Standard care alone

The observation group

OTHER

The observation group employed the modified pressure-reducing fixation protective nasal strip

Device: the modified pressure-reducing fixation protective nasal strip

Interventions

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.

The observation group

Standard care alone DEVICE

standard care plus a hydrocolloid dressing for protection

The control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Meet the diagnostic criteria for respiratory failure, worsening dyspnea, acute exacerbation of chronic obstructive pulmonary disease (COPD), bronchitis, pneumonia, and congestive heart failure.
• \. No severe cognitive impairment.
• \. Good compliance and being able to actively cooperate with the investigation.
• \. No concurrent metabolic diseases.

You may not qualify if:

• \. Patients with severe respiratory failure, severe arrhythmias, concurrent pneumothorax, coma upon admission, or persistent vomiting.
• \. Patients with severe liver failure, kidney failure, or other severe systemic diseases.
• \. Patients with severe cognitive impairment who are unable to understand or comply with the study requirements.
• \. Patients with severe hemodynamic instability.
• \. Patients with allergies to oxygen therapy or protective patch materials.

Sponsors & Collaborators

• Ying Zhou: lead

Study Sites (1)

Wuxi Ninth People's Hospital

Wuxi, Jiangsu, 214000, China

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 6, 2024
• Study Start: January 1, 2024
• Primary Completion: September 15, 2024
• Study Completion: October 1, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

CN (1)