Comparison of Adhesive and Non-adhesive Endotracheal Tube Holder Applied
1 other identifier
interventional
32
1 country
1
Brief 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. . 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
August 30, 2022
CompletedStudy Start
First participant enrolled
February 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2024
CompletedOctober 18, 2024
October 1, 2024
3 days
August 24, 2022
October 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 mounts
Secondary Outcomes (1)
physiological parameter
6 mounts
Study Arms (2)
endotracheal tube fixation
EXPERIMENTALTube 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
EXPERIMENTALTube 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.
Interventions
In patients using adhesive tube holders and non-adhesive tube holders, it will be investigated whether there is bacterial growth on the tube.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients whose tube is removed, Patients who died without a second microbiological swab sample Patients who changed without a second microbiological swab sample
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cumhuriyet University
Sivas, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 22256926BACKGROUNDLandsperger 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.
PMID: 31064406BACKGROUND
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
zuhal gulsoy
Nurse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
August 24, 2022
First Posted
August 30, 2022
Study Start
February 7, 2023
Primary Completion
February 10, 2023
Study Completion
August 19, 2024
Last Updated
October 18, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share