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CompletedNCT05142579Updated Dec 2, 2021

EFFECT OF ENDOTRACHEAL TUBE DETECTION ON PRESSURE

An interventional study of ENDOTRAKEAL TUBE HOLDER and BANDAGE in Pressure Injury, sponsored by Marmara University Pendik Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-12-02.

Sponsored by Marmara University Pendik Training and Research Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2020, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pressure Injury

Keywords

  • Endotracheal Tube
  • Endotracheal Tube Holder
  • Bandage
  • Intensive Care Unit
  • Pressure Wound
03

In context

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 395 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

Marmara University Pendik Training and Research Hospital is the lead sponsor of 32 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Must be between the ages of 18-65
  • Must be intubated oratraceal

Exclusion criteria

Exclusion Criteria:

  • Oral pressure wounds
  • Burns on the face
  • Diabetes
  • Facial and neck trauma
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    ENDOTRACHEAL TUBE HOLDER

    Endotracheal tube holder was used for endotracheal tube detection of patients in this group.

    Other: ENDOTRAKEAL TUBE HOLDER

  • Active comparator
    BANDAGE

    The bandage was used for endotracheal tube detection of patients in this group.

    Other: BANDAGE

Interventions

  • OtherENDOTRAKEAL TUBE HOLDER

    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.

  • OtherBANDAGE

    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.

06

What researchers measure

Primary outcomes

  1. 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

    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.

  2. 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

    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.

07

Study locations

1 site
  • Marmara University Training and Research Hospital
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05142579
Lead sponsor
Marmara University Pendik Training and Research Hospital
Responsible party
Alev Genç (M.Sc NURSE, Marmara University Pendik Training and Research Hospital) — Principal investigator
First posted
Dec 2, 2021
Start date
Jul 1, 2020
Primary completion
Nov 1, 2020
Completion
Nov 1, 2020
Last update
Dec 2, 2021

Study contacts

TÜLİN YILDIZ, PhD
principal investigator · Namik Kemal University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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