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Two Points Versus Three Points Turning in Prevention of Bed Sores in Critically Ill Patients

Primary Purpose

Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
patient positioning
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer focused on measuring pressure ulcer, Positioning

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients admitted to critical care medicine department and expected to have long stay

Exclusion Criteria:

  • active or healed bed sores

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    3 point turning

    2 points turning

    Arm Description

    patients nursed by the traditional re-positioning (two hours on back, two hours on right and two hours on left).

    patients nursed on the right and left side sonly in 30ْ avoiding the back

    Outcomes

    Primary Outcome Measures

    pressure ulcer occurence
    incidence

    Secondary Outcome Measures

    Full Information

    First Posted
    June 10, 2015
    Last Updated
    July 5, 2015
    Sponsor
    University of Alexandria
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02479425
    Brief Title
    Two Points Versus Three Points Turning in Prevention of Bed Sores in Critically Ill Patients
    Official Title
    Two Pints Versus Three Points Turning in Prevention of Bed Sores in Critically Ill Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    July 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alexandria

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Several studies were searched the preventive measures of bed sores. Although repositioning is the mainstay in most preventive measures, there is no evidence to recommend specific turning regimen. The aim of this study is to comparative the impact of the two points repositioning in lateral lying position on the right and left versus the traditional three points repositioning on the right, back, and left in the occurrence of bed sores. This study was conducted on 150 patients admitted to the critical care department of Alexandria Main University Hospital after obtaining an informed consent from their relatives. The investigators excluded patients who: have active or healed bed sores. Patients were randomly divided into two groups by allocated randomization: Group 1: traditional three points rotation. Group 2: two points rotation.
    Detailed Description
    Several studies were searched the preventive measures of bed sores. Although repositioning is the mainstay in most preventive measures, there is no evidence to recommend specific turning regimen. Aim of the study: The aim of this study was designed to evaluate the comparative impact of the two points repositioning in lateral lying position on the right and left versus the traditional three points repositioning on the right, back, and left in the occurrence of bed sores. Patients: This study was conducted on 150 patients admitted to the critical care department of Alexandria Main University Hospital after obtaining an informed consent from their relatives. The investigators excluded patients who: have active or healed bed sores. Patients were randomly divided into two groups by allocated randomization: Group 1: traditional three points rotation. Group 2: two points rotation. Methods: The studied patients were subjected to: Complete history taking, physical examination, primary ICU diagnosis, routine laboratory investigation and recording Glasgaw coma scale (GCS), use of sedation, vasopressors and mechanical ventilation Patients in group 1 nursed by traditional protocol [ two hours on the right side in 30 degree lateral position, two hours on the back and two hours on the left side in 30 degree lateral position] Patients in group 2 nursed in lateral position with 30 degree two hours on the right and two hours on the left with elevation of the head of bed by 30 degree in the two groups. both groups were monitored for bed sores incidence, timing and sites of occurence

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pressure Ulcer
    Keywords
    pressure ulcer, Positioning

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    3 point turning
    Arm Type
    Active Comparator
    Arm Description
    patients nursed by the traditional re-positioning (two hours on back, two hours on right and two hours on left).
    Arm Title
    2 points turning
    Arm Type
    Experimental
    Arm Description
    patients nursed on the right and left side sonly in 30ْ avoiding the back
    Intervention Type
    Procedure
    Intervention Name(s)
    patient positioning
    Intervention Description
    positioning patients, every 2 hours, either to standard (right, back, left sides) or only to right and left sides
    Primary Outcome Measure Information:
    Title
    pressure ulcer occurence
    Description
    incidence
    Time Frame
    21 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients admitted to critical care medicine department and expected to have long stay Exclusion Criteria: active or healed bed sores

    12. IPD Sharing Statement

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