An interventional study of Proning Pillow System in Pressure Ulcer, sponsored by Liverpool University Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Liverpool University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Other
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.
518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 395 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Liverpool University Hospitals NHS Foundation Trust is the lead sponsor of 60 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Proned on standard and proning pillows
Device: 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.
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
| Milestone | Proning |
|---|---|
| Started | 50 |
| Completed | 50 |
| Not completed | 0 |
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.
| mmHg | Proning |
|---|---|
| Peak pressure: proning pillow, chest, male | 88.1 (77.3 to 99.3) |
| Peak pressure: standard pillow, chest, male | 71.5 (59.0 to 72.2) |
| Peak pressure: proning pillow, chest, female | 69.6 (61.9 to 78.8) |
| Peak pressure: standard pillow, chest, female | 64.3 (59.7 to 74.4) |
| Peak pressure: proning pillow, pelvis, healthy males | 70.4 (53.6 to 84.7) |
| Peak pressure: standard pillow, pelvis, healthy males | 40.2 (35.3 to 44.9) |
| Peak pressure: proning pillow, pelvis, overweight males | 96.3 (82.0 to 107.2) |
| Peak pressure: standard pillow, pelvis, overweight males | 47.1 (39.8 to 54.0) |
| Peak pressure: proning pillow, pelvis, healthy females | 86.0 (68.2 to 94.4) |
| Peak pressure: standard pillow, pelvis, healthy females | 45.5 (36.6 to 53.1) |
| Peak pressure: proning pillow, pelvis, overweight females | 84.4 (68.7 to 94.4) |
| Peak pressure: standard pillow, pelvis, overweight females | 45.0 (40.8 to 50.8) |
Collected over 10 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Proning | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
NHS staff
| Age, Categorical(Participants) | Proning |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 50 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Proning |
|---|---|
| Female | 30 |
| Male | 20 |
| Race and Ethnicity Not Collected(Participants) | Proning |
|---|
| Region of Enrollment(Participants) | Proning |
|---|---|
| United Kingdom | 50 |
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Liverpool University Hospitals NHS Foundation Trust