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Proning Pillows for Intensive Care Unit (ICU): Comparison of Chest and Pelvis Interface Pressure Distributions Between a Novel Proning Pillow System and Standard Pillows in Healthy Subjects

Primary Purpose

Pressure Ulcer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Proning Pillow System
Sponsored by
Liverpool University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pressure Ulcer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Work for Liverpool University Hospital NHS Foundation Trust
  • Participant is willing and able to give informed consent for participation in the study.
  • Agree to have weight, height, chest and waist measurements taken
  • Agree to the study protocol
  • Aged 18 years or above.

Exclusion Criteria:

  • Presentation of skin lesions
  • Absence of any limb
  • Female participant who is pregnant
  • Have a lower back problem
  • Pain or injury in shoulders or arms
  • History of conditions that would make it difficult to lie prone, such as pressure injury or surgery within six months leading up to the study
  • Any conditions that significantly affect movement and sensation such as diabetes or mobility limitations

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Proning

    Arm Description

    Proned on standard and proning pillows

    Outcomes

    Primary Outcome Measures

    Chest and pelvis interface pressures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 23, 2021
    Last Updated
    December 7, 2021
    Sponsor
    Liverpool University Hospitals NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05149989
    Brief Title
    Proning Pillows for Intensive Care Unit (ICU): Comparison of Chest and Pelvis Interface Pressure Distributions Between a Novel Proning Pillow System and Standard Pillows in Healthy Subjects
    Official Title
    Proning Pillows for Intensive Care Unit (ICU): Comparison of Chest and Pelvis Interface Pressure Distributions Between a Novel Proning Pillow System and Standard Pillows in Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    March 2022 (Anticipated)
    Study Completion Date
    March 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Liverpool University Hospitals NHS Foundation Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    During the COVID-19 pandemic, intensive care units (ICUs) across the country have been inundated with increasing numbers of COVID patients. Hypoxic patients in ICU require mechanical ventilation and this can be improved by proning these patients to improve oxygenation and prevent ventilator-induced lung injury. Standard practice is to use standard hospital pillows to support the pelvis and chest of the patient while they are proned. These pillows do not provide much support to the patients and often need to be adjusted due to the patient 'sinking' into them. Prolonged pronation also leads to pressure sores in these anatomical locations which burden the Trust financially and also cause distress to patients. A new proning pillow system was developed by Dr Sashika Selladurai and manufactured for the ICU in Aintree hospital which is made from polyurethane memory foam designed to relieve pressure on the patients and prevent pressure sores that often occur during prolonged proning. The pillow system is also designed to withstand the load of heavier patients and reduce the risk of 'sinking' into the pillows when proned for long periods of time. The aim of the study is to compare the performance of the new proning pillow system with standard pillows, particularly in relation to the risk of pressure sores, by evaluating differences in chest and pelvis interface pressures between the two pillow types. This will be done by having healthy NHS staff lie on the pillows in the prone position for a short period of time while recording the pressure distribution on the pillows using pressure mats placed between them and the pillows. This will help understand the relative risk of pressure sores developing when the new pillow system is used. It is hypothesised that the new pillow system does not increase the risk of pressure sores developing. The new proning pillow system is a Class 1 CE marked medical device. The proning pillow system consists of a chest pillow and a pelvis pillow made from memory foam designed to reduce contact pressures and peak interface pressures in patients and allow patients to be placed in neutral position for ventilation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pressure Ulcer

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Proning
    Arm Type
    Experimental
    Arm Description
    Proned on standard and proning pillows
    Intervention Type
    Device
    Intervention Name(s)
    Proning Pillow System
    Intervention Description
    Participants will be asked to lie on the proning pillows in prone position for no more than 5 minutes. Each participant will then be asked to lie on standard hospital pillows for no more than 5 minutes.
    Primary Outcome Measure Information:
    Title
    Chest and pelvis interface pressures
    Time Frame
    10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Work for Liverpool University Hospital NHS Foundation Trust Participant is willing and able to give informed consent for participation in the study. Agree to have weight, height, chest and waist measurements taken Agree to the study protocol Aged 18 years or above. Exclusion Criteria: Presentation of skin lesions Absence of any limb Female participant who is pregnant Have a lower back problem Pain or injury in shoulders or arms History of conditions that would make it difficult to lie prone, such as pressure injury or surgery within six months leading up to the study Any conditions that significantly affect movement and sensation such as diabetes or mobility limitations

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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