Skip to content

Exploring tissue reperfusion in two body positions and varied load periods in critically ill patients. (EXTREME II Pressure Study)

In the critically ill adult patient population, what is the impact of severity of illness and body mass index on tissue reperfusion time in the Supine semi-recumbent and Lateral 1/4 turn position at 2.5-hour and 4-hour time intervals?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000333415
Acronym
EXTREME II pressure study
Enrollment
125
Registered
2016-03-15
Start date
2016-05-11
Completion date
2017-07-20
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The research project aims to better understand how pressure injuries occur and to explore blood flow in seriously ill patients in two lying positions used in the intensive care unit (ICU): on the back and on the side, at 2.5-hour and 4-hour time intervals. The body’s ability to carry oxygenated blood to the tissue is tested using non-invasive, pain-free Doppler technology which measures the time taken for the blood flow to return to the small blood vessels in the tissue, near the surface of the skin. The research project will look into the effect patient body mass index (BMI), level of sickness, patient lying position and the effect that length of time in one lying position has on blood flow to the skin for the ICU patients. The patients will be assessed in the first 72-hours of admission, when they are the most ill and skin checks for pressure injuries will be completed 3-4 times per week until the patients leave hospital.

Interventions

Study Procedures 1. Patient suitability will need to be confirmed on the day of data collection with the registered nurse (RN) assigned to the patient, Clinical Nurse Consultant (CNC), the team leader (usually the CNC), Clinical Co-ordinator (CC) and medical staff member allocated to the patient. A suitable time for data collection will be co-ordinated with relevant staff members of the ICU department 2. When the patient is scheduled for repositioning the bedside nurse will set up the laser Dopp

Study Procedures 1. Patient suitability will need to be confirmed on the day of data collection with the registered nurse (RN) assigned to the patient, Clinical Nurse Consultant (CNC), the team leader (usually the CNC), Clinical Co-ordinator (CC) and medical staff member allocated to the patient. A suitable time for data collection will be co-ordinated with relevant staff members of the ICU department 2. When the patient is scheduled for repositioning the bedside nurse will set up the laser Doppler perfusion monitor (LDPM) equipment at the patient bedside. For data collection the patient will be positioned either on their back (supine semi-recumbent position) or side (lateral quarter turn position), as per the routine ICU repositioning schedule. If the patient has been lying on their back, the research nurse and ICU team will position the patient on their side and data collect on the greater trochanter first or vice versa. The research nurse will talk to the patient and ICU team through the data collection process. 3. The research nurse will tape the LDPM to the surface of the sacrum (when positioned on the back) or greater trochanter (when positioned on the side). 4. Once the LDPM is in place a baseline recording will be taken to record the patients normal tissue perfusion (before loading with pressure). 5. After a stable baseline is recorded, the ICU team will complete the repositioning by turning the patient on their back or side. 6. Once the patient is lying in position and the LDPM recording has started, the research nurse will monitor the LDPM recording and the bedside nurse will continue with the patient cares as normal. The patient will remain in the position for 2.5-hours. 7. After 2.5-hours, the patient will be due for repositioning. The research nurse and ICU team will reposition the patient to offload the LDPM and the tissue reperfusion measurements will be recorded. The reperfusion time will be recorded for approximately 10 minutes. The patient’s body weight will be supported with pillows for comfort for the duration of this time. 8. Once data collection has been completed for the first position the above process will be repeated for the second position. The second position will be recorded for a total of 4-hours. 9. After data collection, the patients routine repositioning will continue for the duration of their stay in ICU; the study will only record tissue reperfusion with the LDPM on one occasion. 10. The research nurse will follow up with skin assessments 3-4 times per week to check for PI development until 20 skin checks have been completed or the patient has been discharged from hospital, whichever occurs first. As the data collection is expected to take 7-8 hours and the study only has one LDPM device the study will only be data collecting a maximum of one patient per day. The eligible patient for the data collection will be the most suitable patient in the ICU that meets study criteria. All patient routine cares will be conducted as normal during this time. If the patients’ health situation changes or they need to be moved from the position during data collection, the data collection will then be ceased as the patients care needs come first. Data collection is only conducted if deemed appropriate by the bedside nurse, Clinical Nurse Consultant and ICU medical team. The data collection form will be used to document the data and prompt the nurse to check pillow placement and bed angles are set to the guidelines in the study procedures

Sponsors

Professor Fiona Coyer
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Critically ill patients will be included if they: 1. are over 18 years. 2. are mechanically ventilated. 3. have been admitted to the Intensive care unit within the past 72 hours.

Exclusion criteria

Critically ill patients will be excluded if they: 1. are receiving non-invasive ventilation (NIV). 2. are unable to turn on one or more of the body positions. 3. are managed in isolation under contact or droplet or airborne precautions. 4. have a diagnosis of burn injury with greater than 40% TBSA. 5. have a burn injury located over the sacrum or over both hip regions. 6. are scheduled for a surgical procedure in theatre on the day of data collection. 7. are managed on spinal precautions. 8. have a diagnosis of a pelvic fracture and are unable to turn. 9. are receiving palliative care. 10. are agitated and do not obey commands as determined by medical or nursing clinicians. 11. are deemed to be in too much pain to turn, as determined by medical or nursing clinicians. 12. are haemodynamically unstable, as determined by medical or nursing clinicians.13. are on three other research protocols in intensive care.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026