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Positioning Duration and Pressure Injury Risk (PIP-ICU)

S

SEMA ŞAHİNER

Status

Invitation-only

Conditions

Risk Assessment
Pressure Injury

Treatments

Behavioral: Position Change - 2 Hours
Behavioral: Position Change - 1 Hour

Study type

Interventional

Funder types

Other

Identifiers

NCT07355439
2024-SBB-0140

Details and patient eligibility

About

This research aims to investigate the effect of positioning times on the risk of pressure injury in critically ill patients.

Full description

Pressure injuries, considered an indicator of quality of care, remain a significant concern today. They are a health problem that reduces the patient's quality of life, complicates the treatment process, and significantly increases costs. Immobility is one of the main risk factors for pressure injury development. In healthy individuals, discomfort occurs in an area subjected to pressure for a long enough period to cause ischemia, and the person changes their position via the afferent sensorimotor feedback system. Fewer than 20 movements per night significantly increase the risk of ulcer development. The factor causing ulcer formation is the inability of the individual to relieve the pressure applied to the tissue. Patients with limited mobility cannot change their body position on their own, and tissue perfusion is impaired in pressure-exposed areas, facilitating ulcer formation. Both the intensity and duration of pressure affect the effect. High pressure causes pressure to build up quickly, while the longer the pressure, the greater the risk of pressure buildup. In individuals at high risk of pressure injuries, frequent position changes are a primary policy for preventing pressure injuries. Experimental studies show that irreversible ischemia occurs when pressure is applied continuously for two hours or longer. The best method for reducing pressure in patients is repositioning. The literature indicates that while pressure injuries cannot be completely prevented, their incidence can be significantly reduced through evidence-based practices, particularly through assessment of at-risk patients, appropriate early nursing interventions, and preventive measures. Advances in the early detection of pressure injuries have been reported in the literature and primarily involve measuring inflammatory markers in anatomical regions to capture the first signs of tissue damage.

Enrollment

82 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • - If the patient is conscious, they must volunteer to participate in the study.
  • For unconscious patients, a first-degree relative (mother, father, spouse, child) must agree to participate in the study.
  • The patient's dependency level score on the Barthel Activities of Daily Living Index must be 90 or below (moderately dependent, severely dependent, completely dependent).
  • The patient must not have developed a pressure injury.
  • The patient must be meeting their daily calorie needs as determined by the nutrition team.
  • There must be no contraindications to turning the patient to any side.
  • Patients who are at low risk according to the pressure injury scale (15 points or above according to the Braden Risk Assessment Scale).
  • The patient must not have an acute neurological problem.
  • Patients with a GCS score above 7.

Exclusion criteria

  • - If the patient is conscious, they do not consent to participate in the study.
  • For unconscious patients, their first-degree relative does not consent to participate in the study.
  • Patients with a Barthel Activities of Daily Living Index score above 90 (mildly dependent, fully independent).
  • The patient has an existing pressure injury.
  • The patient is not meeting their daily calorie needs as determined by the nutrition team.
  • There is a contraindication to turning the patient to any side.
  • Patients with moderate to high risk according to the pressure injury scale (score below 15 according to the Braden Risk Assessment Scale).
  • The patient has an acute neurological problem.
  • Patients with a GCS score of 7 or below.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

82 participants in 2 patient groups

experimental group
Experimental group
Description:
Position changes will be implemented at 1-hour intervals.
Treatment:
Behavioral: Position Change - 1 Hour
control group
Active Comparator group
Description:
Position changes will be implemented at 2-hour intervals.
Treatment:
Behavioral: Position Change - 2 Hours

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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