Pressure Ulcer
Conditions
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.
Interventions
DEVICEProning Pillow System
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.
Sponsors
Liverpool University Hospitals NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Chest and Pelvis Interface Pressures | 10 minutes | The maximum values of pressure measured by the two pressure mats, one placed in the chest region and on in the pelvis region, measured in mmHg. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Proning Proned on standard and proning pillows
Proning Pillow System: 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. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Proning | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 50 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 50 Participants | — |
| Sex: Female, Male Female | 30 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Peak Chest and Pelvis Interface Pressures
The maximum values of pressure measured by the two pressure mats, one placed in the chest region and on in the pelvis region, measured in mmHg.
Time frame: 10 minutes
Population: Population was analysed in two separate groups: male (20) and female (30)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Proning | Peak Chest and Pelvis Interface Pressures | Peak pressure: proning pillow, pelvis, healthy males | 70.4 mmHg |
| Proning | Peak Chest and Pelvis Interface Pressures | Peak pressure: standard pillow, pelvis, healthy males | 40.2 mmHg |
| Proning | Peak Chest and Pelvis Interface Pressures | Peak pressure: proning pillow, pelvis, overweight males | 96.3 mmHg |
| Proning | Peak Chest and Pelvis Interface Pressures | Peak pressure: standard pillow, pelvis, overweight males | 47.1 mmHg |
| Proning | Peak Chest and Pelvis Interface Pressures | Peak pressure: proning pillow, pelvis, healthy females | 86.0 mmHg |
| Proning | Peak Chest and Pelvis Interface Pressures | Peak pressure: standard pillow, pelvis, healthy females | 45.5 mmHg |
| Proning | Peak Chest and Pelvis Interface Pressures | Peak pressure: proning pillow, pelvis, overweight females | 84.4 mmHg |
| Proning | Peak Chest and Pelvis Interface Pressures | Peak pressure: standard pillow, pelvis, overweight females | 45.0 mmHg |
| Proning | Peak Chest and Pelvis Interface Pressures | Peak pressure: proning pillow, chest, male | 88.1 mmHg |
| Proning | Peak Chest and Pelvis Interface Pressures | Peak pressure: standard pillow, chest, male | 71.5 mmHg |
| Proning | Peak Chest and Pelvis Interface Pressures | Peak pressure: proning pillow, chest, female | 69.6 mmHg |
| Proning | Peak Chest and Pelvis Interface Pressures | Peak pressure: standard pillow, chest, female | 64.3 mmHg |