InfectionNCT05521009
Comparison of Adhesive and Non-adhesive Endotracheal Tube Holder Applied
A study of Infection and Intensive Care, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Mechanical ventilation is the continuation of respiratory function from outside by means of special devices until adequate oxygenation is provided by the patient's own respiratory functions in patients whose oxygenation is not sufficient for any reason. . Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Infection, Intensive Care, Nurses Role
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2023to 19 Aug 2024
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age, Patients connected to MV, with endotracheal tube, Patients without intraoral damage patients Patients staying with the tube for three days
Who cannot join
- Patients whose tube is removed, Patients who died without a second microbiological swab sample Patients who changed without a second microbiological swab sample
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Adhesive and Non-adhesive Endotracheal Tube Holder Applied in Intensive Care in Terms of Bacterial Colonization
Mechanical ventilation is the continuation of respiratory function from outside by means of special devices until adequate oxygenation is provided by the patient's own respiratory functions in patients whose oxygenation is not sufficient for any reason. . Mechanical ventilation support is provided to patients with respiratory distress with a medical device called an endotracheal tube (ET) inserted through the mouth or nose. Endotracheal intubation is the most common access route for invasive mechanical ventilation (MV) in critical care areas such as the intensive care unit. As in the intensive care unit, as the tube insertion time increases, it becomes very important to fix the tube so that it does not come out. One of the most important and most common complications after ET placement is unplanned extubation. Correct tube detection is the best way to prevent unplanned extubation. In current clinical practice, there are several methods for securing ETs, including adhesive or cloth tapes and endotracheal tube attachment devices. Although there are many types of endotracheal tube holders today, the use of bandages or tapes is still the most commonly used method. Different endotracheal tube fixation techniques used have different advantages and complications. Skin injury and allergy due to adhesive tapes, which are frequently used in the detection of ET, are complications that can be seen in every patient and age group. Endotracheal tube fixation methods may increase the risk of infection due to the material from which they are produced.We planned this study to determine whether the endotracheal tube fixation tie or the gauze fixation from my tube fixation materials contains pathogens, and if so, the pathogen hosting rates.
Read the detailed description
Mechanical ventilation is the continuation of respiratory function from outside by means of special devices until adequate oxygenation is provided by the patient's own respiratory functions in patients whose oxygenation is not sufficient for any reason. Today, mechanical ventilation is used for various purposes in different environments such as the operating room, intensive care, emergency room and home. Mechanical ventilation support is provided to patients with respiratory distress with a medical device called an endotracheal tube (ET) inserted through the mouth or nose. Endotracheal intubation is the most common access route for invasive mechanical ventilation (MV) in critical care areas such as the intensive care unit. Laryngeal trauma, bronchospasm, hypotension, hypoxemia, airway perforation, and vertebral trauma during endotracheal intubation. many potential complications such as colon injury can be seen. As in the intensive care unit, as the tube insertion time increases, it becomes very important to fix the tube so that it does not dislodge. One of the most important and most common complications after ET placement is unplanned extubation. Correct tube detection is the best way to prevent unplanned extubation. In current clinical practice, there are several methods for securing ETs, including adhesive or cloth tapes and endotracheal tube attachment devices. Although there are many types of endotracheal tube holders today, the use of bandages or tapes remains the most commonly used method. Poor detection of ET may lead to misalignment, slippage, trauma to the airways, or accidental extubation. Excessive pressure of ET detection on facial tissue may cause permanent skin and mucosal damage. Different endotracheal tube fixation techniques used have different advantages and complications. Skin injury and allergy due to adhesive tapes, which are frequently used in the detection of ET, are complications that can be seen in every patient and age group.
There are studies in the literature showing that endotracheal tube fixation methods may increase the risk of infection in relation to the material from which they are produced. In the literature review, it is stated that as a result of the contamination of the adhesive tape with oral secretions in the detection of ET, it prepares an environment for the proliferation of pathogenic microorganisms and increases the risk of infection. ET adhesive tapes cover the mouth in a way that makes oral hygiene difficult due to its wide width. From time to time, the sticky part is left open, which creates an environment prone to infection as a result of the adhesion of unwanted substances such as infection and hair. The evidence is that pathogens are present on existing adhesive tape, and many researchers have found that the adhesive tape is contaminated outside of its original packaging. On the other hand, cotton tapes when tied horizontally (traditionally) cause increased secretions to be absorbed and may therefore harbor infection.
There are currently 3 tube fixation materials in of researches hospital. The first of these is fixation with a sticking tape, the second is fixation with gauze, and the third is commercial cotton tube ties. The sticking tape is not preferred for long-term tube fixation, since its stickiness is lost by getting wet due to the secretion in the mouth of the patients in the intensive care unit. Fixation with gauze is more time consuming in terms of use and requires the use of a cutting tool such as a scalpel to cut the lace, and it is not preferred because it may cause damage and injuries to the tube. Commercial fastening ties, which are easier to use but have adhesive tape at the contact point with the tube, are used in the institution. The pathogen harboring risk that applies to adhesive tapes may also apply to these fixing materials. In addition, as the cares get dirty, the tube fixation material is changed by the nurses and oral care is provided. Each time the fixings are opened, some adhesive tape remains on the tube and a rough surface forms on the tube over time. It is known that pathogen hosting rates are high on rough floors. Choosing the appropriate fixation material in terms of patient safety and performing their care correctly are among the important responsibilities of the intensive care nurse. This study was planned to compare the pathogen harboring rates of endotracheal tube fixation tie and gauze fixation, which are tube fixation materials.
- Conditions
- Infection, Intensive Care, Nurses Role, Patient Care
- Being tested
- Control grup, sticky tube holder
- Keywords
- intensive care, endotracheal tüp, endotracheal tube fixation, infektion, nursing care
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control grup, sticky tube holderOther
Also called adhesive tube holder
In patients using adhesive tube holders and non-adhesive tube holders, it will be investigated whether there is bacterial growth on the tube.
| Study group | Role | What they receive |
|---|---|---|
| endotracheal tube fixation | Experimental | Tube fixation will be performed using a bandage in one of the groups. The patients identified with the bandage will form the control group of the study. The group of the patients to be included in the groups will be determined by drawing lots. Except for the different fixation material, no different application will be made to the patients in oral care. As soon as the patients are intubated, a swab will be taken twice, from the outer surface of the endotracheal tube from the fixation distance, and from the same area 3 days after intubation Receives: Other: Control grup, sticky tube holder |
| Enfection | Experimental | Tube fixation will be performed with adhesive tube fixation material to one of the groups. In which group the patients to be included in the groups will be will be determined by drawing lots. Except for the different fixation material, no different application will be made to the patients in oral care. As soon as the patients are intubated, a swab will be taken twice, from the outer surface of the endotracheal tube from the fixation distance, and from the same area 3 days after intubation. Receives: Other: Control grup, sticky tube holder |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiological parameter
After endotracheal intubation, the level of the tube must be maintained so that the tube does not become dislodged. If the tube enters the lungs too much or goes out, it prevents the patient from breathing. For this reason, it will be recorded that the tube stops at the distance it is inserted.
Measured: 6 mounts
Secondary outcomes (1)
physiological parameter
Pathogen formation associated with fixation material around the endotracheal tube may increase the patient's risk of developing ventilator-associated pneumonia. The presence of potential and the amount of pathogen will be determined by microbiological examination of the tube fixation material area.
Measured: 6 mounts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start7 Feb 2023
- Primary completion10 Feb 2023
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zuhal Gülsoy, Cumhuriyet University
- Investigators
- zuhal gulsoy, Principal investigator, Nurse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521009
- Sponsor's protocol ID
- CU
- Status last verified
- Oct 2024
- First submitted
- 24 Aug 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harris PN, Ashhurst-Smith C, Berenger SJ, Shoobert A, Ferguson JK. Adhesive tape in the health care setting: another high-risk fomite? Med J Aust. 2012 Jan 16;196(1):34. doi: 10.5694/mja11.11211. No abstract available.
PubMed 22256926Landsperger JS, Byram JM, Lloyd BD, Rice TW; Pragmatic Critical Care Research Group. The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial. Crit Care. 2019 May 7;23(1):161. doi: 10.1186/s13054-019-2440-7.
PubMed 31064406
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adhesive and Non-adhesive Endotracheal Tube Holder Applied in Intensive Care in Terms of Bacterial Colonization
- ClinicalTrials.gov ID
- NCT05521009
- Acronym / sponsor ID
- CU
- Conditions
- Infection, Intensive Care, Nurses Role, Patient Care
- Keywords
- intensive care, endotracheal tüp, endotracheal tube fixation, infektion, nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 30 Aug 2022 (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.
Mechanical ventilation is the continuation of respiratory function from outside by means of special devices until adequate oxygenation is provided by the patient's own respiratory functions in patients whose oxygenation is not sufficient for any reason. . Mechanical ventilation support is provided to patients with respiratory distress with a medical device called an endotracheal tube (ET) inserted through the mouth or nose. Endotracheal intubation is the most common access route for invasive mechanical ventilation (MV) in critical care areas such as the intensive care unit. As in the intensive care unit, as the tube insertion time increases, it becomes very important to fix the tube so that it does not come out. One of the most important and most common complications after ET placement is unplanned extubation. Correct tube detection is the best way to prevent unplanned extubation. In current clinical practice, there are several methods for securing ETs, including adhesive or cloth tapes and endotracheal tube attachment devices. Although there are many types of endotracheal tube holders today, the use of bandages or tapes is still the most commonly used method. Different endotracheal tube fixation techniques used have different advantages and complications. Skin injury and allergy due to adhesive tapes, which are frequently used in the detection of ET, are complications that can be seen in every patient and age group. Endotracheal tube fixation methods may increase the risk of infection due to the material from which they are produced.We planned this study to determine whether the endotracheal tube fixation tie or the gauze fixation from my tube fixation materials contains pathogens, and if so, the pathogen hosting rates.
Detailed description
Mechanical ventilation is the continuation of respiratory function from outside by means of special devices until adequate oxygenation is provided by the patient's own respiratory functions in patients whose oxygenation is not sufficient for any reason. Today, mechanical ventilation is used for various purposes in different environments such as the operating room, intensive care, emergency room and home. Mechanical ventilation support is provided to patients with respiratory distress with a medical device called an endotracheal tube (ET) inserted through the mouth or nose. Endotracheal intubation is the most common access route for invasive mechanical ventilation (MV) in critical care areas such as the intensive care unit. Laryngeal trauma, bronchospasm, hypotension, hypoxemia, airway perforation, and vertebral trauma during endotracheal intubation. many potential complications such as colon injury can be seen. As in the intensive care unit, as the tube insertion time increases, it becomes very important to fix the tube so that it does not dislodge. One of the most important and most common complications after ET placement is unplanned extubation. Correct tube detection is the best way to prevent unplanned extubation. In current clinical practice, there are several methods for securing ETs, including adhesive or cloth tapes and endotracheal tube attachment devices. Although there are many types of endotracheal tube holders today, the use of bandages or tapes remains the most commonly used method. Poor detection of ET may lead to misalignment, slippage, trauma to the airways, or accidental extubation. Excessive pressure of ET detection on facial tissue may cause permanent skin and mucosal damage. Different endotracheal tube fixation techniques used have different advantages and complications. Skin injury and allergy due to adhesive tapes, which are frequently used in the detection of ET, are complications that can be seen in every patient and age group.
There are studies in the literature showing that endotracheal tube fixation methods may increase the risk of infection in relation to the material from which they are produced. In the literature review, it is stated that as a result of the contamination of the adhesive tape with oral secretions in the detection of ET, it prepares an environment for the proliferation of pathogenic microorganisms and increases the risk of infection. ET adhesive tapes cover the mouth in a way that makes oral hygiene difficult due to its wide width. From time to time, the sticky part is left open, which creates an environment prone to infection as a result of the adhesion of unwanted substances such as infection and hair. The evidence is that pathogens are present on existing adhesive tape, and many researchers have found that the adhesive tape is contaminated outside of its original packaging. On the other hand, cotton tapes when tied horizontally (traditionally) cause increased secretions to be absorbed and may therefore harbor infection.
There are currently 3 tube fixation materials in of researches hospital. The first of these is fixation with a sticking tape, the second is fixation with gauze, and the third is commercial cotton tube ties. The sticking tape is not preferred for long-term tube fixation, since its stickiness is lost by getting wet due to the secretion in the mouth of the patients in the intensive care unit. Fixation with gauze is more time consuming in terms of use and requires the use of a cutting tool such as a scalpel to cut the lace, and it is not preferred because it may cause damage and injuries to the tube. Commercial fastening ties, which are easier to use but have adhesive tape at the contact point with the tube, are used in the institution. The pathogen harboring risk that applies to adhesive tapes may also apply to these fixing materials. In addition, as the cares get dirty, the tube fixation material is changed by the nurses and oral care is provided. Each time the fixings are opened, some adhesive tape remains on the tube and a rough surface forms on the tube over time. It is known that pathogen hosting rates are high on rough floors. Choosing the appropriate fixation material in terms of patient safety and performing their care correctly are among the important responsibilities of the intensive care nurse. This study was planned to compare the pathogen harboring rates of endotracheal tube fixation tie and gauze fixation, which are tube fixation materials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endotracheal tube fixation | Experimental | Other: Control grup, sticky tube holderTube fixation will be performed using a bandage in one of the groups. The patients identified with the bandage will form the control group of the study. The group of the patients to be included in the groups will be determined by drawing lots. Except for the different fixation material, no different application will be made to the patients in oral care. As soon as the patients are intubated, a swab will be taken twice, from the outer surface of the endotracheal tube from the fixation distance, and from the same area 3 days after intubation |
| Enfection | Experimental | Other: Control grup, sticky tube holderTube fixation will be performed with adhesive tube fixation material to one of the groups. In which group the patients to be included in the groups will be will be determined by drawing lots. Except for the different fixation material, no different application will be made to the patients in oral care. As soon as the patients are intubated, a swab will be taken twice, from the outer surface of the endotracheal tube from the fixation distance, and from the same area 3 days after intubation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years of age, Patients connected to MV, with endotracheal tube, Patients without intraoral damage patients Patients staying with the tube for three days
Key exclusion criteria (1 listed)
- Patients whose tube is removed, Patients who died without a second microbiological swab sample Patients who changed without a second microbiological swab sample
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 |
|---|---|---|
| Control grup, sticky tube holderAlso: adhesive tube holderIn patients using adhesive tube holders and non-adhesive tube holders, it will be investigated whether there is bacterial growth on the tube. | Other | Enfection, endotracheal tube fixation |
Primary outcome
physiological parameter
Time frame: 6 mounts
After endotracheal intubation, the level of the tube must be maintained so that the tube does not become dislodged. If the tube enters the lungs too much or goes out, it prevents the patient from breathing. For this reason, it will be recorded that the tube stops at the distance it is inserted.
1 secondary outcome
physiological parameter
Time frame: 6 mounts
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 18 Oct 2024.
- Background: PubMed 22256926Harris PN, Ashhurst-Smith C, Berenger SJ, Shoobert A, Ferguson JK. Adhesive tape in the health care setting: another high-risk fomite? Med J Aust. 2012 Jan 16;196(1):34. doi: 10.5694/mja11.11211. No abstract available.
- Background: PubMed 31064406Landsperger JS, Byram JM, Lloyd BD, Rice TW; Pragmatic Critical Care Research Group. The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial. Crit Care. 2019 May 7;23(1):161. doi: 10.1186/s13054-019-2440-7.
- 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.
zuhal gulsoy principal investigator
Nurse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Infection and Intensive Care, run by Cumhuriyet University 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 1 inclusion and 1 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 18 Oct 2024. 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?
physiological parameter (time frame: 6 mounts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05521009, which also lists 2 linked publications.
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 18 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.