EFFECT OF ENDOTRACHEAL TUBE DETECTION ON PRESSURE
Primary Purpose
Pressure Injury
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ENDOTRAKEAL TUBE HOLDER
BANDAGE
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Injury focused on measuring Endotracheal Tube, Endotracheal Tube Holder, Bandage, Intensive Care Unit, Pressure Wound
Eligibility Criteria
Inclusion Criteria:
- Must be between the ages of 18-65
- Must be intubated oratraceal
Exclusion Criteria:
- Oral pressure wounds
- Burns on the face
- Diabetes
- Facial and neck trauma
Sites / Locations
- Marmara University Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ENDOTRACHEAL TUBE HOLDER
BANDAGE
Arm Description
Endotracheal tube holder was used for endotracheal tube detection of patients in this group.
The bandage was used for endotracheal tube detection of patients in this group.
Outcomes
Primary Outcome Measures
BANDAGE
It was determined that the bandage method was better than the ETT method in terms of both the pressure ulcer risk score difference and the tendency to fall, dislocate or remain stable
ENDOTRACHEAL TUBE HOLDER
It was determined that the bandage method was better than the ETT method in terms of both the pressure ulcer risk score difference and the tendency to fall, dislocate or remain stable
Secondary Outcome Measures
Full Information
NCT ID
NCT05142579
First Posted
March 30, 2021
Last Updated
November 19, 2021
Sponsor
Marmara University Pendik Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05142579
Brief Title
EFFECT OF ENDOTRACHEAL TUBE DETECTION ON PRESSURE
Official Title
EFFECT OF TWO DIFFERENT ENDOTRACHEAL TUBE DETECTION ON PRESSURE WOUND FORMATION IN INTENSIVE CARE UNIT: A RANDOMIZED CONTROLLED STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University Pendik Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was conducted to examine the effect of two different tube detection on pressure wound formation in the intensive care unit. The search was carried out with a total of 60 patients that 30 of 60 them are interventions and 30 of 60 as experiments, who were hospitalized in the anesthesia and reanimation intensive care unit of an Educational Research Hospital. The 60 patients who made up the sample were assigned 2 groups using a computer program that produced random numbers. For the purpose of the study, the groups were encoded as groups A and B, and each group was tested with two different endotracheal tube detection methods which was applied to the patients in the groups. Data from the study were collected using the introductory and clinical features form, the braden pressure wound risk diagnostic scale, the pressure ulcer recovery assessment scale, the international pressure wound staging system, and the eilers oral assessment guide. Patients in both groups were monitored for four days for oral presure injury. During this process, the tube detection of both groups was changed every 24 hours, and the tubes were repositioned every 4 hours. At the end of the fourth day, wound assesments of patients who developed pressure wounds were performed by using the international pressure staging system and the pressure ulcer recovery assessment scale. Relatives of the patients who were scheduled to conduct the study were informed about the study by oral and written and their consent was obtained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Injury
Keywords
Endotracheal Tube, Endotracheal Tube Holder, Bandage, Intensive Care Unit, Pressure Wound
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The 60 patients who made up the sample were assigned 2 groups using a computer program that produced random numbers. For the purpose of the study, the groups were encoded as groups A and B, and each group was tested with two different endotracheal tube detection methods which was applied to the patients in the groups
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ENDOTRACHEAL TUBE HOLDER
Arm Type
Experimental
Arm Description
Endotracheal tube holder was used for endotracheal tube detection of patients in this group.
Arm Title
BANDAGE
Arm Type
Active Comparator
Arm Description
The bandage was used for endotracheal tube detection of patients in this group.
Intervention Type
Other
Intervention Name(s)
ENDOTRAKEAL TUBE HOLDER
Intervention Description
During this process, the tube detection of endotracheal tube holder was changed every 24 hours, and the tubes were repositioned every 4 hours. On the first day of the study, the oral mucosa of patients in this group was evaluated by the eliers oral evaluation guide.Then, with the Braden pressure wound risk diagnostic scale, patients ' Pressure Wound risk assessment was performed. Patients in this group were monitored for four days for oral pressure wound as of the day they were intubated. During this process, patients ' tube holder was changed every 24 hours and the tube was repositioned every 4 hours. At the end of the fourth day, wound evaluation of patients who developed pressure wounds was performed using the international pressure wound staging system and pressure ulcer Recovery Assessment Scale. In addition, pressure wounds of patients who developed pressure wounds were treated in accordance with the recommendation of a plastic surgeon.
Intervention Type
Other
Intervention Name(s)
BANDAGE
Intervention Description
On the first day of the study, the oral mucosa of patients in this group was evaluated by the eliers oral evaluation guide.Then, with the Braden pressure wound risk diagnostic scale, patients ' Pressure Wound risk assessment was performed. Patients in this group were monitored for four days for oral pressure wound as of the day they were intubated. During this process, patients ' tube holder was changed every 24 hours and the tube was repositioned every 4 hours. At the end of the fourth day, wound evaluation of patients who developed pressure wounds was performed using the international pressure wound staging system and pressure ulcer Recovery Assessment Scale.In addition, pressure wounds of patients who developed pressure wounds were treated in accordance with the recommendation of a plastic surgeon.
Primary Outcome Measure Information:
Title
BANDAGE
Description
It was determined that the bandage method was better than the ETT method in terms of both the pressure ulcer risk score difference and the tendency to fall, dislocate or remain stable
Time Frame
At the end of the 4th day, the wound evaluation of the patients who developed pressure ulcers was made with the International Staging System for Pressure Injuries and The Pressure Ulcer Scale for Healing.
Title
ENDOTRACHEAL TUBE HOLDER
Description
It was determined that the bandage method was better than the ETT method in terms of both the pressure ulcer risk score difference and the tendency to fall, dislocate or remain stable
Time Frame
At the end of the 4th day, the wound evaluation of the patients who developed pressure ulcers was made with the International Staging System for Pressure Injuries and The Pressure Ulcer Scale for Healing.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be between the ages of 18-65
Must be intubated oratraceal
Exclusion Criteria:
Oral pressure wounds
Burns on the face
Diabetes
Facial and neck trauma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TÜLİN YILDIZ, PhD
Organizational Affiliation
Namik Kemal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University Training and Research Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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EFFECT OF ENDOTRACHEAL TUBE DETECTION ON PRESSURE
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