NCT05142579

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

March 30, 2021

Last Update Submit

November 19, 2021

Conditions

Keywords

Endotracheal TubeEndotracheal Tube HolderBandageIntensive Care UnitPressure Wound

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

  • 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

    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.

Study Arms (2)

ENDOTRACHEAL TUBE HOLDER

EXPERIMENTAL

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

Other: ENDOTRAKEAL TUBE HOLDER

BANDAGE

ACTIVE COMPARATOR

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

Other: BANDAGE

Interventions

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.

ENDOTRACHEAL TUBE HOLDER
BANDAGEOTHER

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.

BANDAGE

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Bandages

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • TÜLİN YILDIZ, PhD

    Namik Kemal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.Sc NURSE

Study Record Dates

First Submitted

March 30, 2021

First Posted

December 2, 2021

Study Start

July 1, 2020

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

December 2, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations