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EFFECT OF ENDOTRACHEAL TUBE DETECTION ON PRESSURE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05142579
Recruitment Status : Completed
First Posted : December 2, 2021
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Alev Genç, Marmara University Pendik Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Pressure Injury Other: ENDOTRAKEAL TUBE HOLDER Other: BANDAGE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: EFFECT OF TWO DIFFERENT ENDOTRACHEAL TUBE DETECTION ON PRESSURE WOUND FORMATION IN INTENSIVE CARE UNIT: A RANDOMIZED CONTROLLED STUDY
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : November 1, 2020
Actual Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ENDOTRACHEAL TUBE HOLDER
Endotracheal tube holder was used for endotracheal tube detection of patients in this group.
Other: ENDOTRAKEAL 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.

Active Comparator: BANDAGE
The bandage was used for endotracheal tube detection of patients in this group.
Other: BANDAGE
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.




Primary Outcome Measures :
  1. BANDAGE [ 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. ]
    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

  2. ENDOTRACHEAL TUBE HOLDER [ 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. ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05142579


Locations
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Turkey
Marmara University Training and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Marmara University Pendik Training and Research Hospital
Investigators
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Principal Investigator: TÜLİN YILDIZ, PhD Namik Kemal University
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Responsible Party: Alev Genç, M.Sc NURSE, Marmara University Pendik Training and Research Hospital
ClinicalTrials.gov Identifier: NCT05142579    
Other Study ID Numbers: Marmara EAH-ALEV GENÇ
First Posted: December 2, 2021    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alev Genç, Marmara University Pendik Training and Research Hospital:
Endotracheal Tube
Endotracheal Tube Holder
Bandage
Intensive Care Unit
Pressure Wound
Additional relevant MeSH terms:
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Crush Injuries
Wounds and Injuries