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TEAM: Trial of Early Activity and Mobilization (TEAM)

TEAM: An Multi-centre Observational Study of Early Activity and Mobilization in Australia and New Zealand

Patients in the Intensive Care Unit (ICU) traditionally receive bed rest as part of their care. They develop muscle weakness even after only a few days of mechanical ventilation that may prolong their time in ICU and in hospital, but the nature of such weakness is poorly understood.

The weakness that develops in ICU is more substantial than that which would result from bed rest alone and is referred to as ICU acquired weakness (ICUAW). This weakness might be due to the combination of inflammation and immobility. The exact mechanisms leading to the nerve and muscle damage which occurs in critical illness are not yet fully understood and require further investigation. However, it is known that ICUAW has an effect on a patient's ability to breathe without a ventilator, walk and perform simple activities (like washing and toileting) and often results in longer mechanical ventilation time and hence, longer hospital stays than might otherwise be expected. It may also affect a patient's ability to return home after their hospital stay. The recovery period in Australian and New Zealand ICU patients is unknown but a trial from Canada has reported ongoing weakness five years after leaving ICU. Weakness in survivors of intensive care is known to be a substantial problem. It is currently not known whether ICUAW may be avoided or its severity reduced with simple strategies of early exercise in ICU.

There are no data about the level of activity and mobility in critically ill patients in Australian and New Zealand ICUs. These data are urgently required to plan a program of research to test whether increasing the level of mobility and activity in our critically ill patients is safe, feasible and efficacious in terms of reducing the severity of ICUAW and improving patient-centred outcomes. The program of research will first include a study to observe the mobility levels in 25 ICUs across Australia and New Zealand to determine safety, barriers to mobility and what type of activities are undertaken by our patients.

From the observational data we plan to develop a pilot randomised controlled trial of early mobility and activity in intensive care units across Australia and New Zealand. This simple, cost-effective strategy may improve functional ability, decrease time on mechanical ventilation and improve long term outcomes in this patient group. By initiating such a program, ANZ investigators might be able to change future patient outcomes worldwide.

Studie Overzicht

Studietype

Observationeel

Inschrijving (Werkelijk)

192

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Victoria
      • Melbourne, Victoria, Australië, 3104
        • The Alfred
      • Wellington, Nieuw-Zeeland
        • Wellington Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Intensive care unit patients

Beschrijving

Inclusion Criteria:

  • they have received invasive mechanical ventilation for at least 24 hours, and have been in ICU less than 72 hours
  • the treating clinician expects the patient to still be receiving invasive mechanical ventilation in the ICU the day after tomorrow.

Exclusion Criteria:

  • Age less than 18 years old

    • Patient has a proven or suspected acute primary brain process that is likely to result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury after cardiac arrest or asphyxiation.
    • Second or subsequent admission to ICU during a single hospital admission
    • Patient does not speak English
    • Patient has proven or suspected primary myopathic or neurological process associated with prolonged weakness, such as Guillain-Barre syndrome
    • Death is deemed imminent and inevitable
    • Inability to walk without assistance prior to the acute illness that is associated with admission to ICU (use of a cane or walker not an exclusion)
    • Cognitive impairment prior to the acute illness that is associated with admission to ICU (refer data dictionary)
    • Any written "Rest In Bed" or non-weight bearing medical order such as may occur with hip fracture, unstable spine or pelvis, pathological fracture

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Cohort
  • Tijdsperspectieven: Prospectief

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Best level of activity in ICU
Tijdsspanne: ICU stay (average 7 days)

Highest level of activity (11 point scale) including:

unknown nothing (lying in bed, passive stretches) sitting in bed, active exercises in bed moved to chair (via hoist, slide etc but no standing) sitting over edge of bed standing transferring bed to chair marching on spot (at bedside) walking with assistance of 2 or more people walking with assistance of 1 person walking independently with a gait aid walking independently without a gait aid

ICU stay (average 7 days)
Dosage of the best level of activity
Tijdsspanne: Intensive care unit stay (average 7 days)
The time spent performing the best level of activity and the number of times it is achieved
Intensive care unit stay (average 7 days)
Time to standing in ICU
Tijdsspanne: Intensive care stay (average 7 days)
The number of days in ICU before a patient can stand
Intensive care stay (average 7 days)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Best level of activity at hospital discharge
Tijdsspanne: Hospital stay (median days 14)

Highest level of activity (11 point scale) including:

unknown nothing (lying in bed, passive stretches) sitting in bed, active exercises in bed passively moved to chair (pat slide, hoist but no standing) sitting over edge of bed standing transferring bed to chair marching on spot (at bedside) walking with assistance of 2 or more people walking with assistance of 1 person walking independently with a gait aid walking independently without a gait aid

Hospital stay (median days 14)
Time to first sit out of bed
Tijdsspanne: ICU stay (average 7 days)
The number of days until the patient can sit out of bed
ICU stay (average 7 days)
Barriers to mobilisation
Tijdsspanne: Intensive care unit stay (average 7 days)
Factors that may have been a barrier to mobilizing patients in the ICU
Intensive care unit stay (average 7 days)
Mobilization related adverse events
Tijdsspanne: Intensive care unit stay (average 7 days)
Adverse events that occured during patient mobilization such as an unplanned extubation or a fall to the floor
Intensive care unit stay (average 7 days)
Time to first physiotherapy
Tijdsspanne: Intensive care unit stay (average 7 days)
The number of days in intensive care before the patient was reviewed by a physiotherapist
Intensive care unit stay (average 7 days)
Mechanical ventilation free days
Tijdsspanne: 28 days
The number of mechanical ventilation free days to day 28
28 days
Intensive care unit free days
Tijdsspanne: Day 28
The number of days the patient spent out of ICU to day 28 (if dead = 0)
Day 28
90 day mortality
Tijdsspanne: 90 days
The mortality at day 90
90 days
Health related quality of life at 6 months
Tijdsspanne: 6 months
Health related quality of life reported via telephone interview at 6 months using the EuroQoL EQ5D
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie stoel: Carol Hodgson, PhD, ANZIC-RC
  • Studie directeur: Steve Webb, MD, ANZICS CTG
  • Studie directeur: Rinaldo Bellomo, MD, ANZIC-RC
  • Hoofdonderzoeker: Megan Harrold, PhD Candidate, Royal Perth Hospital
  • Hoofdonderzoeker: Heidi Buhr, RN, Royal Prince Alfred Hospital, Sydney, Australia
  • Hoofdonderzoeker: Manoj Saxena, MD, St George Hospital
  • Hoofdonderzoeker: Paul Young, MD, Wellington Hospital
  • Hoofdonderzoeker: Oystein Tronstad, PT, Prince Charles Hospital
  • Hoofdonderzoeker: Neil Orford, MD, Barwon Health

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2012

Primaire voltooiing (Werkelijk)

1 maart 2014

Studie voltooiing (Werkelijk)

1 maart 2014

Studieregistratiedata

Eerst ingediend

14 augustus 2012

Eerst ingediend dat voldeed aan de QC-criteria

27 augustus 2012

Eerst geplaatst (Schatting)

29 augustus 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

6 mei 2015

Laatste update ingediend die voldeed aan QC-criteria

4 mei 2015

Laatst geverifieerd

1 mei 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ICF

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