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
About this trial
This is an interventional other trial for Pressure Ulcer
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
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
NCT ID
NCT05149989
First Posted
November 23, 2021
Last Updated
December 7, 2021
Sponsor
Liverpool University Hospitals NHS Foundation Trust
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
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
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