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Clinical Trials/NCT06720129
NCT06720129
Completed
Not Applicable

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

Ying Zhou1 site in 1 country60 target enrollmentStarted: January 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Ying Zhou
Enrollment
60
Locations
1
Primary Endpoint
Interval Time for Changing the Fixation Strap

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

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.

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:

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

  • 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.)

Investigators

Sponsor
Ying Zhou
Sponsor Class
Other Gov
Responsible Party
Sponsor Investigator
Principal Investigator

Ying Zhou

Principal Investigator

Wuxi Ninth People's Hospital

Study Sites (1)

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