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

Not Applicable

Completed

• Conditions: High-Flow Nasal Cannula Therapy

• Registration Number: NCT06720129
• Lead Sponsor: Ying Zhou

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-09-15
• Study Completion: 2024-10-01
• Study First Submitted: 2024-11-21
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparison of Comfort Levels	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.
Adverse Event Incidence	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.

Trial Locations

Locations (1)

Wuxi Ninth People's Hospital; 🇨🇳 Wuxi, Jiangsu, China