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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.

연구 개요

연구 유형

관찰

등록 (실제)

192

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Wellington, 뉴질랜드
        • Wellington Hospital
    • Victoria
      • Melbourne, Victoria, 호주, 3104
        • The Alfred

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Intensive care unit patients

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 보병대
  • 시간 관점: 유망한

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Best level of activity in ICU
기간: 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
기간: 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
기간: Intensive care stay (average 7 days)
The number of days in ICU before a patient can stand
Intensive care stay (average 7 days)

2차 결과 측정

결과 측정
측정값 설명
기간
Best level of activity at hospital discharge
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 28 days
The number of mechanical ventilation free days to day 28
28 days
Intensive care unit free days
기간: Day 28
The number of days the patient spent out of ICU to day 28 (if dead = 0)
Day 28
90 day mortality
기간: 90 days
The mortality at day 90
90 days
Health related quality of life at 6 months
기간: 6 months
Health related quality of life reported via telephone interview at 6 months using the EuroQoL EQ5D
6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2012년 7월 1일

기본 완료 (실제)

2014년 3월 1일

연구 완료 (실제)

2014년 3월 1일

연구 등록 날짜

최초 제출

2012년 8월 14일

QC 기준을 충족하는 최초 제출

2012년 8월 27일

처음 게시됨 (추정)

2012년 8월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 5월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 5월 4일

마지막으로 확인됨

2015년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ICF

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

3
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