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Effects of unconsciousness during spinal immobilization on tissue-interface pressures

Effects of unconsciousness during spinal immobilization on tissue-interface pressures: a randomized controlled trial comparing a standard rigid spineboard with a newly developed soft-layered long spineboard

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN96064657
Enrollment
30
Registered
2014-04-24
Start date
2008-02-15
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Spinal immobilization in unconscious patients Injury, Occupational Diseases, Poisoning

Interventions

Two different support devices designed for prehospital trauma care are tested: a standard long spineboard (Ferno-Washington, Wilmington, OH), and a prototype soft-layered long spineboard (Technovas, M

Sponsors

Maastricht University Medical Center (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18 or older 2. Enlisted for abdominal wall herniation repair under general aneasthetics at our Day Surgery facility 3. Expected surgery duration of less than two hours

Exclusion criteria

Exclusion criteria: History of pressure ulcers, pain other than related to the abdominal wall herniation

Design outcomes

Primary

MeasureTime frame
Tissue-interface pressures in mmHg, as measured by an Xsensor 9612 pressure mapping mat. Tissue-interface pressures are measured continuously for the whole time the patient lies on the device. Analyses are done on average tissue-interface pressures during the first minute, 15th minute and last minute of the measurement.

Secondary

MeasureTime frame
1. Redness of the back. This is visually judged prior to surgery, when the patient is in the waiting room of the Day Surgery facility; and directly after surgery when the patient is transferred from the device to the recovery bed. At both time points a photo is taken for judgement by the second judge. 2. Pain is assessed when the patient is in the waiting room of the Day Surgery facility, and 2 hours after surgery, using a 10-point VAS with 0=no pain and 10=worst pain imaginable. Specifically the patient is asked to judge pain on the scapulae, upper back, lower back, buttocks and heels. The patient is asked to disregard any pain from the abdominal wall herniation or from the surgery.

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026