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临床试验/NCT06720129
NCT06720129已完成不适用

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 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Interval Time for Changing the Fixation Strap

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

The control group

Other

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

干预措施: Standard care alone (Device)

The observation group

Other

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

干预措施: the modified pressure-reducing fixation protective nasal strip (Device)

结局指标

主要结局

Interval Time for Changing the Fixation Strap

时间窗: 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

时间窗: 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

时间窗: 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

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

次要结局

  • 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.)

研究者

发起方
Ying Zhou
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Ying Zhou

Principal Investigator

Wuxi Ninth People's Hospital

研究点 (1)

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