Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04682925 |
| Other study ID # |
MYesilyurt |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2021 |
| Est. completion date |
June 15, 2022 |
Study information
| Verified date |
July 2023 |
| Source |
Necmettin Erbakan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study was planned as a prospective randomized controlled clinical trial to determine the
effect of evidence-based skin care interventions and hydrocolloid dressings in preventing
nasogastric induced pressure injuries in critically ill patients.
Description:
Intensive care patients in whom a large number of medical devices are applied during the
treatment and care process are at risk for medical device-related pressure injuries.One of
the most common medical tools applied to these patients is the nasogastric tube.These tubes,
which are applied to provide nasal decompression and enteral nutrition, cause pressure
injuries in the nasal mucosa and nasal wings of the patients.These wounds prevent the patient
from feeding, delay the healing process by causing the nasogastric tube to be pulled, delay
the healing process, cause the patient to experience discomfort and pain by re-inserting the
tube from the other nostril, and increase the cost of treatment and care.Guidelines for
prevention of pressure injuries, which include evidence-based recommendations, report that
these wounds can be prevented with evidence-based skin care interventions and hydrocolloid
dressings. This study was planned as a prospective randomized controlled clinical trial to
determine the effect of evidence-based skin care interventions and hydrocolloid dressings in
preventing nasogastric induced pressure injuries in critically ill patients. In the
literature, there is no study evaluating the effect of evidence-based skin care and / or
hydrocolloid dressings on pressure injuries caused by nasogastric tube. Therefore, a study
demonstrating that hydrocolloid dressing reduce pressure injuries to the nasal arch due to
non-invasive mechanical ventilation were referenced in the sample calculation. In the sample
selection, it was determined that the rate of pressure injury (n: 27/49) developed more in
those who did not use hydrocolloids than those who were used (n: 6/73). In the sample
calculation made in the G * Power (3.1.9.2) program, it was determined that a total of 56
patients, including at least 28 patients in each study group, should be included in the
sample. It was predicted that 20% of the sample could be lost during the data collection
process, and in this study, which was planned with three arms (control, skin care,
hydrocolloid dressing), it was determined that the research sample should be 102, with at
least 34 patients on each arm. The patients included in the study will be assigned to the
experimental group (skin care, hydrocolloid dressing) and control group by balanced block
randomization method according to the randomization list in a ratio of 1: 1:1. In the study,
block randomization was performed by a statistician based on the patients age. The final
evaluation of the patients included in the study will be made on the day of the wound in
those with pressure sores. In other patients, it will be performed on the 18th day of the
nasogastric tube, considering the literature data that pressure injuries occur within 2-7 and
11 ± 6.17 days after tube insertion. For those whose nasogastric tube is removed before the
18th day, the last follow-up will be done on the day the tube is removed. For the
implementation of the study, permission was obtained from the ethics committee of Republic of
Turkey Ministry of Health, Turkey Pharmaceuticals and Medical Devices Agency Ethics
Committee, and work permit was obtained from Necmettin Erbakan University Meram Medical
Faculty Hospital Chief Physician. Patients/patient guardian included in the study sample will
be informed before the study that the purpose of the study and participation in the study is
in line with the principle of volunteering, and "Informing and Consent of Volunteers Consent
Form" will be signed.
Data collection tools;
- Personal Information Form,
- The form containing the characteristics of the treatment and care process in the
Intensive Care Unit
- The form containing the features associated with the nasogastric tube,
- A chart recording the state of nasogastric tube pressure injury, the area of occurrence
and its stage, Independent variables
- Identifying features of patients,
- Evaluations and follow-ups during the treatment and care process,
- Interventions to prevent nasogastric tube pressure injury (routine clinical care,
evidence-based skin care interventions, hydrocolloid dressing) Dependent variables
- Pressure injury originating from nasogastric tube Evaluation of the Data In the
evaluation of the descriptive data obtained from the research, number, percentage,
average and standard deviation will be used; The conformity of the data to normal
distribution will be determined by Kolmogorov-Smirnov test and normal distribution
curve, Skewness and Kurtosis test, and when the data show normal distribution,
parametric tests will be used, and nonparametric tests will be used in the analysis of
data that do not conform to the normal distribution. Significance will be evaluated
within the confidence interval of 95%, p <0.05 will be taken.
İmplementation of the research Patients who are 18 years of age or older, who have a
nasogastric tube inserted after admission to the intensive care unit, and whose nasogastric
tube stay is planned to be at least 48 hours will be included in the sample group.
Participants in the experimental group( evidence-based skin care), evidence-based skin care
interventions in the guidelines to prevent medical device-related pressure injuries will be
applied twice daily to the nasal mucosa and nasal wing under the nasogastric tube.
Participants in the experimental group( hydrocolloid dressing), hydrocolloid dressing will be
applied daily to the nasal mucosa and nasal wing of the patients under the nasogastric tube
to prevent pressure injuries caused by medical devices.
Participants in the control group will be given no intervention , these patients will receive
the routine care(dressing change and nasal skin cleaning once a day) applied in the intensive
care unit.
