Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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.

Panoramica dello studio

Tipo di studio

Osservativo

Iscrizione (Effettivo)

192

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Victoria
      • Melbourne, Victoria, Australia, 3104
        • The Alfred
      • Wellington, Nuova Zelanda
        • Wellington Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Intensive care unit patients

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Coorte
  • Prospettive temporali: Prospettiva

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Best level of activity in ICU
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Intensive care stay (average 7 days)
The number of days in ICU before a patient can stand
Intensive care stay (average 7 days)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Best level of activity at hospital discharge
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 28 days
The number of mechanical ventilation free days to day 28
28 days
Intensive care unit free days
Lasso di tempo: Day 28
The number of days the patient spent out of ICU to day 28 (if dead = 0)
Day 28
90 day mortality
Lasso di tempo: 90 days
The mortality at day 90
90 days
Health related quality of life at 6 months
Lasso di tempo: 6 months
Health related quality of life reported via telephone interview at 6 months using the EuroQoL EQ5D
6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2012

Completamento primario (Effettivo)

1 marzo 2014

Completamento dello studio (Effettivo)

1 marzo 2014

Date di iscrizione allo studio

Primo inviato

14 agosto 2012

Primo inviato che soddisfa i criteri di controllo qualità

27 agosto 2012

Primo Inserito (Stima)

29 agosto 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

6 maggio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 maggio 2015

Ultimo verificato

1 maggio 2015

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • ICF

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

3
Sottoscrivi