Clinical trial NCT00961012: The Big Squeeze (Lessening the Big Squeeze: The Effect of the Trunk Release on Interface Pressures of Individuals Seated in a High Fowler's Positions)
Official title: Lessening the Big Squeeze: The Effect of the Trunk Release on Interface Pressures of Individuals Seated in a High Fowler's Positions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Keywords: Randomized control trial
pressure mapping
High Fowler's position
bed
ventilation
slow vital capacity
older adult population
65 years and older
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2009-08-18
Enrollment: 129
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Older adults with a disability tend to spend greater periods of time in bed each day and often over a mealtime. To make it safe for them to eat in bed, the patient is placed in a high Fowler's position. This means that the head and the foot of the bed are raised to sit the person up.

Sitting up in bed increases pressure over the buttocks which can lead to the development of a pressure ulcer. The purpose of this study is to evaluate the impact of the positional change called "the trunk release" on pressure over the buttocks, on breathing and on comfort.

Primary Hypothesis - Performing the trunk release with an older adult population at low risk for pressure ulcer will result in a 5mmHg decrease in the peak pressure index over the sacral-coccygeal area as measured by the peak pressure index using a Force Sensitive Applications (FSA) Pressure Mapping System.

Secondary Hypotheses - Performing the trunk release with an older adult population at low risk for pressure ulcer will result in:

* Improved ventilation as measured by a 0.5 liter increase in slow vital capacity.
* Greater comfort as measured by a two point change on a horizontal numeric scale with word anchors combined with the Wong-Baker faces scale (Appendix D).
* A four-centimetre displacement of the trunk as it extends up towards the head of the bed.

Detailed description: Two research assistants will conduct the study. Experimenter A assists with recruitment of subjects, sets up the test environment and performs the trunk release. Experimenter B acts as the primary data collector and will be kept blind to the purpose of the study.

The randomized allocation indicates if the subject is in the intervention or control group. Experimenter A sets up the study hospital bed fitted with a visco-elastic foam mattress, a fitted sheet, a flat sheet and the torso pressure-sensing mat. For standardization, the mat is aligned with markers set on the bed frame. Subjects will wear hospital pajamas over undergarments. Experimenter B records height, weight, age and gender. Subject is seated in a chair and is instructed in the spirometry maneuver. Once the subject is comfortable with the maneuver, Experimenter A asks the subject to lie supine with their body centered on the bed and with their hands resting on their abdomen. Experimenter A reminds the subject to remain completely immobile for the duration of data collection. Experimenter B takes a baseline measure of discomfort as per protocol. Experimenter A places the subject in the High Fowler's position by raising the foot of the bed to its highest position, 50 degrees, and the head of the bed to its highest position, 60 degrees. Experimenter A sets the timer for 8 minutes as per pressure mapping protocol. For more stable values, a "settling time" of 8 minutes is required to factor in creep of the pressure mapping sensors and mattress. Experimenter A aims the laser beam to the top of the scapulae where the subject's shoulder meets the mattress surface. Experimenter B initiates a FSA file with the subject's number, takes a pressure reading once 8 minutes is up, measures the trunk displacement, obtains spirometry readings as per protocol, and takes a measure of discomfort. Experimenter B leaves the room, Experimenter A sets the timer for 5 minutes and opens the allocation envelope.

The Principal Investigator will conduct random spot checks to ensure consistency in set-up.

Eligibility criteria: Inclusion Criteria:

* 65 years or older
* Residents, families, friends and volunteers of Vancouver Community Residential facilities
* Able to understand and follow instructions
* At low risk for bed sores

Exclusion Criteria:

* None

Primary outcomes:
measure: Performing trunk release with older adults at low risk for pressure ulcer results in 5mmHg decrease in peak pressure index over the sacral-coccygeal area measured by peak pressure index using Force Sensitive Applications Pressure Mapping System.
Secondary outcomes:
measure: Ventilation as measured by a increase or decrease in slow vital capacity.
timeFrame: after 13 minutes of the treatment
measure: Comfort as measured by a horizontal numeric scale with word anchors combined with the Wong-Baker faces scale (Appendix D).
timeFrame: after 13 minutes of the treatment
measure: A displacement of the trunk as it extends up towards the head of the bed.
timeFrame: after 13 minutes of the treatment
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital - Banfield Pavilion
state: British Columbia
city: Vancouver
country: Canada
facility: George Pearson Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Dogwood Lodge
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia Hospital - Purdy Pavilion
state: British Columbia
Study officials:
affiliation: Vancouver Coastal Health
name: Guylaine Desharnais
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: William C. Miller
role: STUDY_DIRECTOR
affiliation: Vancouver Coastal Health
name: Jeanette A. Boily
role: STUDY_DIRECTOR
affiliation: Vancouver Coastal Health
name: Pat Camp
role: STUDY_DIRECTOR
References: