Pressure InjuryNCT05142579
EFFECT OF ENDOTRACHEAL TUBE DETECTION ON PRESSURE
A study testing ENDOTRAKEAL TUBE HOLDER and BANDAGE in people with Pressure Injury, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pressure Injury
- What is being tested?
- ENDOTRAKEAL TUBE HOLDER and BANDAGE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 1 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be between the ages of 18-65
- Must be intubated oratraceal
Who cannot join
- Oral pressure wounds
- Burns on the face
- Diabetes
- Facial and neck trauma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Training and Research Hospital
Istanbul
About this study
Official title: EFFECT OF TWO DIFFERENT ENDOTRACHEAL TUBE DETECTION ON PRESSURE WOUND FORMATION IN INTENSIVE CARE UNIT: A RANDOMIZED CONTROLLED STUDY
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.
- Conditions
- Pressure Injury
- Being tested
- ENDOTRAKEAL TUBE HOLDER, BANDAGE
- Keywords
- Endotracheal Tube, Endotracheal Tube Holder, Bandage, Intensive Care Unit, Pressure Wound
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDOTRAKEAL TUBE HOLDEROther
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.
BANDAGEOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ENDOTRACHEAL TUBE HOLDER | Experimental | Endotracheal tube holder was used for endotracheal tube detection of patients in this group. Receives: Other: ENDOTRAKEAL TUBE HOLDER |
| BANDAGE | Active comparator | The bandage was used for endotracheal tube detection of patients in this group. Receives: Other: BANDAGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Jul 2020
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alev Genç, Marmara University Pendik Training and Research Hospital
- Investigators
- TÜLİN YILDIZ, PhD, Principal investigator, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142579
- Sponsor's protocol ID
- Marmara EAH-ALEV GENÇ
- Status last verified
- Nov 2021
- First submitted
- 30 Mar 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF TWO DIFFERENT ENDOTRACHEAL TUBE DETECTION ON PRESSURE WOUND FORMATION IN INTENSIVE CARE UNIT: A RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT05142579
- Acronym / sponsor ID
- Marmara EAH-ALEV GENÇ
- Conditions
- Pressure Injury
- Keywords
- Endotracheal Tube, Endotracheal Tube Holder, Bandage, Intensive Care Unit, Pressure Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| ENDOTRACHEAL TUBE HOLDER | Experimental | Other: ENDOTRAKEAL TUBE HOLDEREndotracheal tube holder was used for endotracheal tube detection of patients in this group. |
| BANDAGE | Active comparator | Other: BANDAGEThe bandage was used for endotracheal tube detection of patients in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be between the ages of 18-65
- Must be intubated oratraceal
Key exclusion criteria (4 listed)
- Oral pressure wounds
- Burns on the face
- Diabetes
- Facial and neck trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENDOTRAKEAL TUBE HOLDERDuring 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. | Other | ENDOTRACHEAL TUBE HOLDER |
| BANDAGEOn 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. | Other | BANDAGE |
Primary outcome
BANDAGE
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.
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
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TÜLİN YILDIZ, PhD principal investigator
Namik Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDOTRAKEAL TUBE HOLDER and BANDAGE in people with Pressure Injury, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BANDAGE (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.