NCT05521009

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 7, 2023

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2024

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

3 days

First QC Date

August 24, 2022

Last Update Submit

October 16, 2024

Conditions

Keywords

intensive careendotracheal tüpendotracheal tube fixationinfektionnursing care

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

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

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.

Other: Control grup, sticky tube holder

Interventions

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

Also known as: adhesive tube holder
Enfectionendotracheal tube fixation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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: 22256926BACKGROUND
  • 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.

    PMID: 31064406BACKGROUND

Related Links

MeSH Terms

Conditions

Infections

Study Officials

  • zuhal gulsoy

    Nurse

    PRINCIPAL INVESTIGATOR

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

Locations