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)

Lessening the Big Squeeze: The Effect of the Trunk Release on Interface Pressures of Individuals Seated in a High Fowler's Positions

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.

Study Overview

• Status: Completed
• Conditions: Elderly
• Intervention / Treatment: Procedure: The Big Squeeze

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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital - Banfield Pavilion
    • Vancouver, British Columbia, Canada, V6P 1S1
      • George Pearson Centre
    • Vancouver, British Columbia, Canada, V6P 6E8
      • Dogwood Lodge
    • Vancouver, British Columbia, Canada, V6T 2B5
      • University of British Columbia Hospital - Purdy Pavilion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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 randomization/ allocation envelope.	Procedure: The Big Squeeze; Trunk release as per MSIP protocol. Standing at the foot of the bed, facing the subject, Experimenter A grasps both ends of the flat sheet to pull the trunk forward and away from the mattress surface. As the trunk release procedure is performed, Experimenter A checks to verify that the laser beam shines through to the opposite wall to confirm that the shoulders have cleared the mattress.
No Intervention: Control group; Experimenter A reminds the subject to remain immobile. For both intervention and control group. After the five-minute period, experimenter A calls experimenter B to return. Experimenter B takes a pressure reading, measures the trunk displacement, obtains spirometry readings, and takes a measure of discomfort.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Ventilation as measured by a increase or decrease in slow vital capacity.	after 13 minutes of the treatment
Comfort as measured by a horizontal numeric scale with word anchors combined with the Wong-Baker faces scale (Appendix D).	after 13 minutes of the treatment
A displacement of the trunk as it extends up towards the head of the bed.	after 13 minutes of the treatment

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Guylaine Desharnais, Vancouver Coastal Health; Study Director: William C. Miller, University of British Columbia; Study Director: Jeanette A. Boily, Vancouver Coastal Health; Study Director: Pat Camp, Vancouver Coastal Health

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: August 14, 2009
• First Submitted That Met QC Criteria: August 17, 2009
• First Posted (Estimate): August 18, 2009

Study Record Updates

• Last Update Posted (Estimate): November 23, 2011
• Last Update Submitted That Met QC Criteria: November 21, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: ventilation; Randomized control trial; pressure mapping; High Fowler's position; bed; slow vital capacity; older adult population; 65 years and older
• Other Study ID Numbers: H09-01370