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

December 5, 2024 updated by: Ying Zhou
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Wuxi, Jiangsu, China, 214000
        • Wuxi Ninth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: The control group
The control group received standard care plus a hydrocolloid dressing for protection
Device: Standard care alone
standard care plus a hydrocolloid dressing for protection
Other: The observation group
The observation group employed the modified pressure-reducing fixation protective nasal strip
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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:
The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.
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.
The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of Comfort Levels
Time Frame: 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.
Assessed on the 3th day after the start of the experiment
Adverse Event Incidence
Time Frame: 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.
The time from receiving high-flow nasal cannula (HFNC) therapy to removal as per medical advice. up to a month.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Gender
Time Frame: The time from admission to discharge. up to 6 weeks.
The time from admission to discharge. up to 6 weeks.
Age
Time Frame: The time from admission to discharge. up to 6 weeks.
The time from admission to discharge. up to 6 weeks.
Length of hospital stay
Time Frame: The time from admission to discharge. up to 6 weeks.
The time from admission to discharge. up to 6 weeks.
Days of treatment use
Time Frame: The time from admission to discharge. up to 6 weeks.
The time from admission to discharge. up to 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ying Zhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KS2024035

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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