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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00961012
First received: August 14, 2009
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

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.

Condition Intervention
Elderly
Procedure: The Big Squeeze

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Lessening the Big Squeeze: The Effect of the Trunk Release on Interface Pressures of Individuals Seated in a High Fowler's Positions

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ventilation as measured by a increase or decrease in slow vital capacity. [ Time Frame: after 13 minutes of the treatment ] [ Designated as safety issue: No ]
  • Comfort as measured by a horizontal numeric scale with word anchors combined with the Wong-Baker faces scale (Appendix D). [ Time Frame: after 13 minutes of the treatment ] [ Designated as safety issue: No ]
  • A displacement of the trunk as it extends up towards the head of the bed. [ Time Frame: after 13 minutes of the treatment ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: September 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00961012

Locations
Canada, British Columbia
Vancouver General Hospital - Banfield Pavilion
Vancouver, British Columbia, Canada, V5Z 1M9
University of British Columbia Hospital - Purdy Pavilion
Vancouver, British Columbia, Canada, V6T 2B5
George Pearson Centre
Vancouver, British Columbia, Canada, V6P 1S1
Dogwood Lodge
Vancouver, British Columbia, Canada, V6P 6E8
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Guylaine Desharnais Vancouver Coastal Health Authority
Study Director: William C. Miller University of British Columbia
Study Director: Jeanette A. Boily Vancouver Coastal Health Authority
Study Director: Pat Camp Vancouver Coastal Health Authority
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00961012     History of Changes
Other Study ID Numbers: H09-01370
Study First Received: August 14, 2009
Last Updated: November 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Randomized control trial
pressure mapping
High Fowler's position
bed
ventilation
slow vital capacity
older adult population
65 years and older

ClinicalTrials.gov processed this record on April 17, 2014