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

NCT ID: NCT06720129

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

The control group

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

Group Type: OTHER

Standard care alone

Intervention Type: DEVICE

standard care plus a hydrocolloid dressing for protection

The observation group

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

Group Type: OTHER

the modified pressure-reducing fixation protective nasal strip

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Standard care alone

standard care plus a hydrocolloid dressing for protection

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ying Zhou

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ying Zhou

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Wuxi Ninth People's Hospital

Wuxi, Jiangsu, China

Countries

China

Other Identifiers

KS2024035

Identifier Type: -

Identifier Source: org_study_id