Early MobilizationNCT02804516
Recognition and Management of Early Mobilization in ICUs : Practice Patterns in China
A study testing the nurse did early mobilization and the nurse do not do early mobilization in people with Early Mobilization, run by Southeast University, China.
Trial summary
Despite evidence to support early mobilization（EM）for critically ill patients,current status in Chinese ICUs is unknown.Understanding current practice patterns and challenges is essential to inform future research and strategies. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Early Mobilization
- What is being tested?
- the nurse did early mobilization and the nurse do not do early mobilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Aug 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- pediatric ICUs
Trial locations and contacts
No sites are listed yet.
About this study
Despite evidence to support early mobilization（EM）for critically ill patients,current status in Chinese ICUs is unknown.Understanding current practice patterns and challenges is essential to inform future research and strategies.
Read the detailed description
Practice guideline recommend EM in ICU,feasibility, safety and efficacy are confirmed by evidence-based data.However,the prevalence of EM in ICU patients is still low.Moreover,most of the prevalence studies come from developed countries, such as: Australia and New England the United States and Europe. Many ICUs in non-western countries are suffering from a lack of medical resources including health care personnel and medical equipment.
A retrospective observational study.To access the implementation of Chinese intensive care units and hospitals to early mobilization.Secondary objectives were to evaluate structure and process parameters of Chinese hospitals that were associated with implementation.
- Conditions
- Early Mobilization
- Being tested
- the nurse did early mobilization, the nurse do not do early mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the nurse did early mobilizationBehavioural
the nurses know and do what is the early mobilization in ICU
the nurse do not do early mobilizationBehavioural
the nurses do not know and do what is the early mobilization in ICU
| Study group | Role | What they receive |
|---|---|---|
| the nurse did early mobilization | Experimental | the nurses know and do what is the early mobilization in ICU Receives: Behavioral: the nurse did early mobilization |
| the nurse do not do early mobilization | Experimental | the nurses do not know and do what is the early mobilization in ICU Receives: Behavioral: the nurse do not do early mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
the implementation rates for early mobility
the application of physical activity within the first 2 to 5 days of critically illness or injury
Measured: within the first 2 to 5 days of critically illness or injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early MobilizationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804516
- Sponsor's protocol ID
- 218.94.112.98/Login.aspx
- Status last verified
- Jun 2016
- First submitted
- 10 Jun 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recognition and Management of Early Mobilization in ICUs : Practice Patterns in China
- ClinicalTrials.gov ID
- NCT02804516
- Acronym / sponsor ID
- 218.94.112.98/Login.aspx
- Conditions
- Early Mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Aug 2016 (estimated)
- First posted
- 17 Jun 2016 (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.
Despite evidence to support early mobilization（EM）for critically ill patients,current status in Chinese ICUs is unknown.Understanding current practice patterns and challenges is essential to inform future research and strategies.
Detailed description
Practice guideline recommend EM in ICU,feasibility, safety and efficacy are confirmed by evidence-based data.However,the prevalence of EM in ICU patients is still low.Moreover,most of the prevalence studies come from developed countries, such as: Australia and New England the United States and Europe. Many ICUs in non-western countries are suffering from a lack of medical resources including health care personnel and medical equipment.
A retrospective observational study.To access the implementation of Chinese intensive care units and hospitals to early mobilization.Secondary objectives were to evaluate structure and process parameters of Chinese hospitals that were associated with implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the nurse did early mobilization | Experimental | Behavioral: the nurse did early mobilizationthe nurses know and do what is the early mobilization in ICU |
| the nurse do not do early mobilization | Experimental | Behavioral: the nurse do not do early mobilizationthe nurses do not know and do what is the early mobilization in ICU |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- pediatric ICUs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the nurse did early mobilizationthe nurses know and do what is the early mobilization in ICU | Behavioural | the nurse did early mobilization |
| the nurse do not do early mobilizationthe nurses do not know and do what is the early mobilization in ICU | Behavioural | the nurse do not do early mobilization |
Primary outcome
the implementation rates for early mobility
Time frame: within the first 2 to 5 days of critically illness or injury
the application of physical activity within the first 2 to 5 days of critically illness or injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing the nurse did early mobilization and the nurse do not do early mobilization in people with Early Mobilization, run by Southeast University, China.
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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun Pan, Dr (+862583262550, panchun1982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the implementation rates for early mobility (time frame: within the first 2 to 5 days of critically illness or injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2016.