Comparison of Adhesive and Non-adhesive Endotracheal Tube Holder Applied

NCT ID: NCT05521009

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2024-08-19

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

endotracheal tube fixation

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

Group Type: EXPERIMENTAL

Control grup, sticky tube holder

Intervention Type: OTHER

In patients using adhesive tube holders and non-adhesive tube holders, it will be investigated whether there is bacterial growth on the tube.

Enfection

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.

Group Type: EXPERIMENTAL

Control grup, sticky tube holder

Intervention Type: OTHER

In patients using adhesive tube holders and non-adhesive tube holders, it will be investigated whether there is bacterial growth on the tube.

Interventions

Control grup, sticky 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.

Intervention Type: OTHER

Other Intervention Names

adhesive tube holder

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Patients whose tube is removed, Patients who died without a second microbiological swab sample Patients who changed without a second microbiological swab sample

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

Zuhal Gülsoy

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zuhal gulsoy

Role: PRINCIPAL_INVESTIGATOR

Nurse

Locations

Cumhuriyet University

Sivas, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 22256926 (View on PubMed)

Landsperger 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.

Reference Type: BACKGROUND

PMID: 31064406 (View on PubMed)

Related Links

http://www.apsf.org/newsletters/html/2011/winter/10_ivtape.htm

Related Info

Other Identifiers

CU

Identifier Type: -

Identifier Source: org_study_id