ISRCTN - ISRCTN96064657: Effects of unconsciousness during spinal immobilization on tissue-interface pressures

Plain English Summary

Background and study aims
Victims of a serious accident such as an car crash are often transported to the hospital on a rigid spineboard. A spineboard is a rigid device designed to protect the spine when spinal injury is suspected. Because it is very uncomfortable and even painful to lie on a rigid spineboard, we developed a softer type of spineboard. It is important to know if the spine and other body parts are sufficiently supported by the device. One way to test this is by looking at the contact the body makes with the device by using a pressure mapping mat. We have already done this in healthy, awake volunteers. Now we want to test the support in anaesthetised patients to see how the device would support an unconscious or paralyzed patient. Because lying on a device may also influence blood supply to the skin, we also look at the skin at the back of the patient.

Who can participate?
Men and women aged 18 or older undergoing abdominal wall herniation repair under general anaesthetic at our Day Surgery facility.

What does the study involve?
If you decide to participate in this study, before the surgery you will be asked to describe any pain (other than that related to the abdominal wall herniation) on a scale of 0 (no pain) to 10 (worst imaginable pain). Also, your back will be assessed for any redness and a photo will be taken of your back. After you are put under general anaesthetic, you will be randomly allocated to be placed on one of the two spineboards being investigated. The spineboard is equipped with a special pressure mapping mat, which continuously registers the pressure between the body and the spineboard. After the surgery, when you are transferred from the spineboard to a bed from the recovery department, you will be rolled onto your side and your back will be judged for redness and a photo will be taken. Two hours after the end of the surgery, when the anaesthetic has worn off, you will be asked to describe any pain and your back will be assessed for any redness. Awake healthy volunteers will also be placed on each spineboard for 15 minutes, with an interval between the devices of 5 minutes, while pressures are recorded continuously.

What are the possible benefits and risks of participating?
There are no benefits for the patients participating in this study but future victims of a serious accident may benefit from the results obtained in this study. The risks are the development of passing redness of the back and passing pain in the back.

Where is the study run from?
The study is run from the Maastricht University Medical Center in Maastricht, Netherlands.

When is the study starting and how long is it expected to run for?
The study ran from February 2008 to February 2010.

Who is funding the study?
Maastricht University Medical Center (Netherlands).

Who is the main contact?
Prof Peter Brink
p.brink@mumc.nl

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Brink

ORCID ID

Contact details

P. Debyelaan 25
Maastricht
6229HX
Netherlands
p.brink@mumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ToetsingOnline NL 18313.068.0

Study information

Scientific title

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

Acronym

Study hypothesis

This study investigates the hypothesis that when lying on a rigid spineboard, unconsciousness results in higher tissue-interface pressure compared to the awake status. Our second hypothesis is that there is no difference in tissue-interface pressure between anaesthetized and awake status when lying on the soft-layered long spineboard.

Ethics approval

The Medical Research Ethics Committee of the Maastricht University Medical Center, ref. MEC 07-2-050

Study design

Single-center prospective randomized single-blinded comparative study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Spinal immobilization in unconscious patients

Intervention

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, Meerssen, The Netherlands). After induction of anesthesia, patients are randomly assigned to one of the two devices. The pressure-mapping mat is placed on the device and the patient is then placed on the device. Pressure is recorded during the entire surgery. Before, directly after and 2 hours after surgery the back is visually inspected for redness. Before and 2 hours after surgery the patient is asked to judge pain on a VAS scale with 0=no pain and 10=worst possible pain. The control group consists of awake healthy volunteers who are randomly put on each device for 15 minutes, with an interval between the devices of 5 minutes, while tissue-interface pressures are recorded continuously.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

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 outcome measures

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.

Overall trial start date

15/02/2008

Overall trial end date

15/02/2010

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

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

Recruitment start date

15/02/2008

Recruitment end date

15/02/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

P. Debyelaan 25
Maastricht
6229HX
Netherlands

Sponsor information

Organisation

Maastricht University Medical Center (Netherlands)

Sponsor details

Department - Network Acute Care Limburg
P. Debyelaan 25
Maastricht
6229HX
Netherlands
netwerkacutezorglimburg@mumc.nl