Critical CarePhase 2NCT00787098
Investigating Modes of Progressive Mobility
A Phase 2 study testing ETM protocol in people with Critical Care and Mechanical Ventilation, run by Hill-Rom.
Trial summary
The purpose of this study is to compare the effects of specific activities with and without an early therapeutic mobility (ETM) protocol among patients who experience three or more days of mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Mechanical Ventilation, Intensive Care
- What is being tested?
- ETM protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Jul 2009
- Phase
- Phase 2
- 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
Who may be able to join
- P:F ratio > 100
- FiO2 < 60% and PEEP less than 10 cmH20
- hemodynamic stability ten minutes after turning (i.e., heart rate (HR) and/or systolic blood pressure (BP) changes less than 20% of baseline)
- baseline (rest) vitals signs of HR 50-110
- mean arterial pressure (MAP) 60-100 mmHg
- peripheral oxygenation saturation (SpO2) greater than 88%
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- Sufficient cognition for progression to levels 2-4 of ETM to assist with out of bed positioning or movement
- a high degree of dependency on others for positioning is acceptable
- there are no exclusions based on gender or minority status.
Who cannot join
- End-stage muscular dystrophy
- myasthenia gravis
- new quadriplegia
- coma
- increased intracranial pressure
- unrepaired hip fracture and multiple lower extremity fractures
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- Patients experiencing active titration of intravenous vasoactive medications (e.g. dopamine, epinephrine, or norepinepherine) will be excluded
- concurrent use of a continuous lateral rotation bed
- patients for high risk of death will also be excluded
- MICU admission following a hospital stay of >9 days in the past months
- age >80 in the presence of 2 or more life-threatening illnesses
- diagnosis of an active stage IV malignancy
- status post cardiac arrest
- diagnosis of intracerebral hemorrhage requiring mechanical ventilation
- subjects over 400 pounds can be excluded from mobilization based on the judgment of the bedside nurse or project manager; if the risk for staff or patient harm from moving a patient with excessive weight is considered likely, mobilization will not occur.
About this study
The purpose of this study is to compare the effects of specific activities with and without an early therapeutic mobility (ETM) protocol among patients who experience three or more days of mechanical ventilation. A second purpose is to examine staff/delivery system and patient factors that influence the initiation and progression of activity with and without an ETM protocol. The hypothesis is that ETM protocols will result in improved patient outcomes.
Read the detailed description
The specific aims of this study are to:
- Compare patient responses to selected modes of therapy (activity) without and with an ETM protocol
- Molecular responses: markers of inflammation interleukin (IL)-6 and IL-10
- Physiological responses: peripheral oxygen saturation, heart rate, blood pressure, new dysrhythmias
- Safety/Unsafe events including pain, fatigue, line or tube dislodgement, fall or near fall
- Determine the associations between duration and level of activity/ETM achieved and outcomes:
- occurrence of delirium
- occurrence of ventilator associated pneumonia
- occurrence of deep vein thrombosis or pulmonary emboli
- occurrence of acquired pressure ulcer
- muscle strength
- number of days mechanically ventilated
- discharge location (after ICU)
- Describe strategies used in the ICU to initiate and implement activity with and without an ETM protocol
- use of personnel such as registered nurses, physical therapists, respiratory therapist and nursing assistants
- use of equipment such as a walker, lift device, belt or bed
- perception of sufficient time and abilities
- Describe patient factors that are associated with implementation of ETM
- Potentially modifiable exemplars: sedation, site of vascular access, physician orders
- Potentially nonmodifiable exemplars: weight, consciousness, hemodynamic instability, terminal condition
This is a prospective, longitudinal, repeated measures study with a control period, run-in period and intervention period. Data will be collected during all three periods for comparison. During the control period, patients will receive standard care. Standard care in this institution does not include a program of progressive or early mobility but does include activities similar to the ETM protocol, implemented at the discretion of the staff. During the run-in period, subjects will receive a mix of standard care and the intervention.
- Being tested
- ETM protocol
- Keywords
- therapeutic mobility, acute care, nursing, inflammatory markers
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETM protocolOther
ETM is 4 levels. Level 1, each receives repositioning from lateral to supine positions at even hours, totaling 60 minutes of activity/positioning over 24 hours. If tolerated, two periods of 20 minutes of supine position with a reverse trendelenberg position of 15-20 degrees will be used to promote orthostasis. Level 2 is turning every 2 hours, positioning in reverse trendelenberg at 15-25 degrees as tolerated, active resistance with ICU staff for 20 minutes daily for a total of 60-80 minutes of activity/positioning daily. At Level 3, 2 times 20 minutes of a sitting are added to active ROM and inbed turning (estimated 80-100 total minutes of activity daily). Sitting is in bed or with non-weightbearing assisted transfer to chair with backrest elevation at 75-90 degrees and legs in a dependent position. Level 3 interventions; minimal weight-bearing. Level 4, weight-bearing transfer to chair and ambulation are added to inbed turning.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | RA begins data collection with chart review for demographic and explanatory variables, collects data for baseline muscle strength. During standard care period, PM will obtain information about the plan for activity for enrolled patients (turning, complete or partial weight-bearing i.e., reverse Trendelenberg positioning, ROM, sitting and walking) through discussion with the direct providers. RA will interview one provider about factors which influence the decision to implement activity or provide bedrest, including the presence of orders for bedrest or physical therapy. If activity is planned, the PM will observe and record the type and duration of activity, drawing serum biomarkers 20 minutes before and 20 minutes after the activity. If no activity is planned or activity duration is less than 10 minutes, serum for only baseline inflammatory biomarkers will be drawn. The RA will collect outcomes data within 24 hours of discharge from the ICU. |
| 2 | Experimental | Identical procedures for date recruitment, consent and data collection will occur. In this phase, the Project Manager will promote the use of the ETM protocol through coaching (e.g., reminding staff of benefits of mobility, identification of available resources, or suggesting cessation of bedrest orders) and by participating in planning at least one 20-minute activity. Receives: Other: ETM protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare immediate molecular and physiological patient responses to activity with responses to an ETM protocol.
Measured: 1, 2, 3, 7, days then weekly
Secondary outcomes (1)
A secondary aim is to identify strategies and conditions that promote or prevent ETM.
Measured: 1, 3, 5, 7, days then weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startNov 2007
- Primary completionApr 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Chris Winkelman, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787098
- Sponsor's protocol ID
- CR-0076
- Status last verified
- Jul 2009
- First submitted
- 6 Nov 2008
- Last updated
- 3 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
PubMed 18596631
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Modes of Progressive Mobility
- ClinicalTrials.gov ID
- NCT00787098
- Acronym / sponsor ID
- CR-0076
- Keywords
- therapeutic mobility, acute care, nursing, inflammatory markers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 7 Nov 2008 (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.
The purpose of this study is to compare the effects of specific activities with and without an early therapeutic mobility (ETM) protocol among patients who experience three or more days of mechanical ventilation. A second purpose is to examine staff/delivery system and patient factors that influence the initiation and progression of activity with and without an ETM protocol. The hypothesis is that ETM protocols will result in improved patient outcomes.
Detailed description
The specific aims of this study are to:
- Compare patient responses to selected modes of therapy (activity) without and with an ETM protocol
- Molecular responses: markers of inflammation interleukin (IL)-6 and IL-10
- Physiological responses: peripheral oxygen saturation, heart rate, blood pressure, new dysrhythmias
- Safety/Unsafe events including pain, fatigue, line or tube dislodgement, fall or near fall
- Determine the associations between duration and level of activity/ETM achieved and outcomes:
- occurrence of delirium
- occurrence of ventilator associated pneumonia
- occurrence of deep vein thrombosis or pulmonary emboli
- occurrence of acquired pressure ulcer
- muscle strength
- number of days mechanically ventilated
- discharge location (after ICU)
- Describe strategies used in the ICU to initiate and implement activity with and without an ETM protocol
- use of personnel such as registered nurses, physical therapists, respiratory therapist and nursing assistants
- use of equipment such as a walker, lift device, belt or bed
- perception of sufficient time and abilities
- Describe patient factors that are associated with implementation of ETM
- Potentially modifiable exemplars: sedation, site of vascular access, physician orders
- Potentially nonmodifiable exemplars: weight, consciousness, hemodynamic instability, terminal condition
This is a prospective, longitudinal, repeated measures study with a control period, run-in period and intervention period. Data will be collected during all three periods for comparison. During the control period, patients will receive standard care. Standard care in this institution does not include a program of progressive or early mobility but does include activities similar to the ETM protocol, implemented at the discretion of the staff. During the run-in period, subjects will receive a mix of standard care and the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –RA begins data collection with chart review for demographic and explanatory variables, collects data for baseline muscle strength. During standard care period, PM will obtain information about the plan for activity for enrolled patients (turning, complete or partial weight-bearing i.e., reverse Trendelenberg positioning, ROM, sitting and walking) through discussion with the direct providers. RA will interview one provider about factors which influence the decision to implement activity or provide bedrest, including the presence of orders for bedrest or physical therapy. If activity is planned, the PM will observe and record the type and duration of activity, drawing serum biomarkers 20 minutes before and 20 minutes after the activity. If no activity is planned or activity duration is less than 10 minutes, serum for only baseline inflammatory biomarkers will be drawn. The RA will collect outcomes data within 24 hours of discharge from the ICU. |
| 2 | Experimental | Other: ETM protocolIdentical procedures for date recruitment, consent and data collection will occur. In this phase, the Project Manager will promote the use of the ETM protocol through coaching (e.g., reminding staff of benefits of mobility, identification of available resources, or suggesting cessation of bedrest orders) and by participating in planning at least one 20-minute activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- P:F ratio > 100
- FiO2 < 60% and PEEP less than 10 cmH20
- hemodynamic stability ten minutes after turning (i.e., heart rate (HR) and/or systolic blood pressure (BP) changes less than 20% of baseline)
- baseline (rest) vitals signs of HR 50-110
- mean arterial pressure (MAP) 60-100 mmHg
Key exclusion criteria (15 listed)
- End-stage muscular dystrophy
- myasthenia gravis
- new quadriplegia
- coma
- increased intracranial pressure
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 |
|---|---|---|
| ETM protocolETM is 4 levels. Level 1, each receives repositioning from lateral to supine positions at even hours, totaling 60 minutes of activity/positioning over 24 hours. If tolerated, two periods of 20 minutes of supine position with a reverse trendelenberg position of 15-20 degrees will be used to promote orthostasis. Level 2 is turning every 2 hours, positioning in reverse trendelenberg at 15-25 degrees as tolerated, active resistance with ICU staff for 20 minutes daily for a total of 60-80 minutes of activity/positioning daily. At Level 3, 2 times 20 minutes of a sitting are added to active ROM and inbed turning (estimated 80-100 total minutes of activity daily). Sitting is in bed or with non-weightbearing assisted transfer to chair with backrest elevation at 75-90 degrees and legs in a dependent position. Level 3 interventions; minimal weight-bearing. Level 4, weight-bearing transfer to chair and ambulation are added to inbed turning. | Other | 2 |
Primary outcome
Compare immediate molecular and physiological patient responses to activity with responses to an ETM protocol.
Time frame: 1, 2, 3, 7, days then weekly
1 secondary outcome
A secondary aim is to identify strategies and conditions that promote or prevent ETM.
Time frame: 1, 3, 5, 7, days then weekly
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 3 Jul 2009.
- Background: PubMed 18596631Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
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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.
Chris Winkelman, PhD principal investigator
Case Western Reserve University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ETM protocol in people with Critical Care and Mechanical Ventilation, run by Hill-Rom.
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 9 inclusion and 15 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 3 Jul 2009. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Compare immediate molecular and physiological patient responses to activity with responses to an ETM protocol. (time frame: 1, 2, 3, 7, days then weekly). 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 NCT00787098, which also lists 1 linked publication.
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 3 Jul 2009.