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.
Visão geral do estudo
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
British Columbia
-
Vancouver, British Columbia, Canadá, V5Z 1M9
- Vancouver General Hospital - Banfield Pavilion
-
Vancouver, British Columbia, Canadá, V6P 1S1
- George Pearson Centre
-
Vancouver, British Columbia, Canadá, V6P 6E8
- Dogwood Lodge
-
Vancouver, British Columbia, Canadá, V6T 2B5
- University of British Columbia Hospital - Purdy Pavilion
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
|
Sem intervenção: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
|---|
|
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.
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Ventilation as measured by a increase or decrease in slow vital capacity.
Prazo: after 13 minutes of the treatment
|
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).
Prazo: after 13 minutes of the treatment
|
after 13 minutes of the treatment
|
|
A displacement of the trunk as it extends up towards the head of the bed.
Prazo: after 13 minutes of the treatment
|
after 13 minutes of the treatment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Guylaine Desharnais, Vancouver Coastal Health
- Diretor de estudo: William C. Miller, University of British Columbia
- Diretor de estudo: Jeanette A. Boily, Vancouver Coastal Health
- Diretor de estudo: Pat Camp, Vancouver Coastal Health
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- H09-01370
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .