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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)

21. November 2011 aktualisiert von: University of British Columbia

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

129

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

65 Jahre und älter (Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verfahren: 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.
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Ventilation as measured by a increase or decrease in slow vital capacity.
Zeitfenster: 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).
Zeitfenster: 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.
Zeitfenster: after 13 minutes of the treatment
after 13 minutes of the treatment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of British Columbia

Ermittler

  • Hauptermittler: Guylaine Desharnais, Vancouver Coastal Health
  • Studienleiter: William C. Miller, University of British Columbia
  • Studienleiter: Jeanette A. Boily, Vancouver Coastal Health
  • Studienleiter: Pat Camp, Vancouver Coastal Health

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2009

Primärer Abschluss (Tatsächlich)

1. April 2011

Studienabschluss (Tatsächlich)

1. April 2011

Studienanmeldedaten

Zuerst eingereicht

14. August 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. August 2009

Zuerst gepostet (Schätzen)

18. August 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

23. November 2011

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. November 2011

Zuletzt verifiziert

1. November 2011

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • H09-01370

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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