Critically Ill Adults Ventilated >24 Hours in Intensive CareTEAMNCT01674608
TEAM: Trial of Early Activity and Mobilization
An observational study of Critically Ill Adults Ventilated >24 Hours in Intensive Care, run by Australian and New Zealand Intensive Care Research Centre at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Adults Ventilated >24 Hours in Intensive Care
- How many people
- 192 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care unit patients
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read more
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.
- Keywords
- intensive care, mobilization, rehabilitation, critical care
What is being measured
The primary outcome is the main question the study is designed to answer.
Best level of activity in ICU
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
Measured: ICU stay (average 7 days)
Dosage of the best level of activity
The time spent performing the best level of activity and the number of times it is achieved
Measured: Intensive care unit stay (average 7 days)
Time to standing in ICU
The number of days in ICU before a patient can stand
Measured: Intensive care stay (average 7 days)
Secondary outcomes (9)
Best level of activity at hospital discharge
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
Measured: Hospital stay (median days 14)
Time to first sit out of bed
The number of days until the patient can sit out of bed
Measured: ICU stay (average 7 days)
Barriers to mobilisation
Factors that may have been a barrier to mobilizing patients in the ICU
Measured: Intensive care unit stay (average 7 days)
Mobilization related adverse events
Adverse events that occured during patient mobilization such as an unplanned extubation or a fall to the floor
Measured: Intensive care unit stay (average 7 days)
Time to first physiotherapy
The number of days in intensive care before the patient was reviewed by a physiotherapist
Measured: Intensive care unit stay (average 7 days)
Mechanical ventilation free days
The number of mechanical ventilation free days to day 28
Measured: 28 days
Intensive care unit free days
The number of days the patient spent out of ICU to day 28 (if dead = 0)
Measured: Day 28
90 day mortality
The mortality at day 90
Measured: 90 days
Health related quality of life at 6 months
Health related quality of life reported via telephone interview at 6 months using the EuroQoL EQ5D
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critically Ill Adults Ventilated >24 Hours in Intensive CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Intensive Care Foundation, Australia
- Responsible party
- Sponsor
- Investigators
- Carol Hodgson, PhD, Study chair, ANZIC-RCSteve Webb, MD, Study director, ANZICS CTGRinaldo Bellomo, MD, Study director, ANZIC-RCMegan Harrold, PhD Candidate, Principal investigator, Royal Perth HospitalSusan Berney, PhD, Principal investigator, Austin HealthHeidi Buhr, RN, Principal investigator, Royal Prince Alfred Hospital, Sydney, AustraliaManoj Saxena, MD, Principal investigator, St. George's Hospital, LondonPaul Young, MD, Principal investigator, Wellington Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674608
- Sponsor's protocol ID
- ICF
- Acronym
- TEAM
- Status last verified
- May 2015
- First submitted
- 14 Aug 2012
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
TEAM Study Investigators; Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, Harrold M, Higgins A, Presneill J, Saxena M, Skinner E, Young P, Webb S. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care. 2015 Feb 26;19(1):81. doi: 10.1186/s13054-015-0765-4.
PubMed 25715872Tipping CJ, Bailey MJ, Bellomo R, Berney S, Buhr H, Denehy L, Harrold M, Holland A, Higgins AM, Iwashyna TJ, Needham D, Presneill J, Saxena M, Skinner EH, Webb S, Young P, Zanni J, Hodgson CL. The ICU Mobility Scale Has Construct and Predictive Validity and Is Responsive. A Multicenter Observational Study. Ann Am Thorac Soc. 2016 Jun;13(6):887-93. doi: 10.1513/AnnalsATS.201510-717OC.
PubMed 27015233
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEAM: An Multi-centre Observational Study of Early Activity and Mobilization in Australia and New Zealand
- ClinicalTrials.gov ID
- NCT01674608
- Acronym / sponsor ID
- TEAM / ICF
- Keywords
- intensive care, mobilization, rehabilitation, critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- Intensive Care Foundation, Australia
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care unit patients
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- Age less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Best level of activity in ICU
Time frame: 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
Dosage of the best level of activity
Time frame: Intensive care unit stay (average 7 days)
The time spent performing the best level of activity and the number of times it is achieved
Time to standing in ICU
Time frame: Intensive care stay (average 7 days)
The number of days in ICU before a patient can stand
9 secondary outcomes
Best level of activity at hospital discharge
Time frame: Hospital stay (median days 14)
Time to first sit out of bed
Time frame: ICU stay (average 7 days)
Barriers to mobilisation
Time frame: Intensive care unit stay (average 7 days)
Mobilization related adverse events
Time frame: Intensive care unit stay (average 7 days)
Time to first physiotherapy
Time frame: Intensive care unit stay (average 7 days)
Mechanical ventilation free days
Time frame: 28 days
Intensive care unit free days
Time frame: Day 28
90 day mortality
Time frame: 90 days
Health related quality of life at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Results publication: PubMed 25715872TEAM Study Investigators; Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, Harrold M, Higgins A, Presneill J, Saxena M, Skinner E, Young P, Webb S. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care. 2015 Feb 26;19(1):81. doi: 10.1186/s13054-015-0765-4.
- Derived from this study: PubMed 27015233Tipping CJ, Bailey MJ, Bellomo R, Berney S, Buhr H, Denehy L, Harrold M, Holland A, Higgins AM, Iwashyna TJ, Needham D, Presneill J, Saxena M, Skinner EH, Webb S, Young P, Zanni J, Hodgson CL. The ICU Mobility Scale Has Construct and Predictive Validity and Is Responsive. A Multicenter Observational Study. Ann Am Thorac Soc. 2016 Jun;13(6):887-93. doi: 10.1513/AnnalsATS.201510-717OC.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Hodgson, PhD study chair
ANZIC-RC
Steve Webb, MD study director
ANZICS CTG
Rinaldo Bellomo, MD study director
ANZIC-RC
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill Adults Ventilated >24 Hours in Intensive Care, run by Australian and New Zealand Intensive Care Research Centre at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best level of activity in ICU (time frame: ICU stay (average 7 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01674608, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015; AzTrials last refreshed its copy on 6 Nov 2026.