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)

NCT00961012 | Completed DMC

• 1 other identifier: H09-01370
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 4

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.

Conditions

Elderly

Keywords

Randomized control trial; pressure mapping; High Fowler's position; bed; ventilation; slow vital capacity; older adult population; 65 years and older

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

The Big Squeeze PROCEDURE

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.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (4)

Vancouver General Hospital - Banfield Pavilion

Vancouver, British Columbia, V5Z 1M9, Canada

Location

George Pearson Centre

Vancouver, British Columbia, V6P 1S1, Canada

Location

Dogwood Lodge

Vancouver, British Columbia, V6P 6E8, Canada

Location

University of British Columbia Hospital - Purdy Pavilion

Vancouver, British Columbia, V6T 2B5, Canada

Location

MeSH Terms

Conditions

Bornholm Eye Disease; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guylaine Desharnais

  Vancouver Coastal Health

  PRINCIPAL INVESTIGATOR

• William C. Miller

  University of British Columbia

  STUDY DIRECTOR

• Jeanette A. Boily

  Vancouver Coastal Health

  STUDY DIRECTOR

• Pat Camp

  Vancouver Coastal Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 18, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 23, 2011

Record last verified: 2011-11

Locations

CA (4)