Early Mobilization of Mechanically Ventilated PatientsNCT03329924
ICU Liberation: Does Enhanced Patient Mobilization Improve Outcomes?
An observational study of Early Mobilization of Mechanically Ventilated Patients, run by Bassett Healthcare at 1 site in United States.
Trial summary
The hypothesis of this study is that an early mobilization program coupled with organizational efforts to implement the ABCDEF bundle will increase the rate of ICU patient mobilization and decrease the ICU length of stay, but will not significantly affect patient mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Mobilization of Mechanically Ventilated Patients
- What is being tested?
- Activity level measurement by accelerometer
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 1 Jan 2023
- 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: Patients in a rural mixed surgical and medical ICU requiring mechanical ventilation will be included in this study
Who may be able to join
- - Patients in a rural mixed surgical and medical ICU requiring mechanical ventilation
Who cannot join
- age less than 18
- Pregnant patients
- Cardiac surgery patients
- "boarding" patients in the ICU
- Patients expected to be extubated in less than 24 total hours (e.g. combative trauma patient intubated in order to complete workup),
- Patients unable to walk prior to admission
- Patients without limbs
- Patients with an unstable spinal injury.
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis of this study is that an early mobilization program coupled with organizational efforts to implement the ABCDEF bundle will increase the rate of ICU patient mobilization and decrease the ICU length of stay, but will not significantly affect patient mortality. Mobilization efforts will be done to improve patient care and the study will allow for measurement of the effects of implementation of this effort. The early mobilization program is being instituted as standard of care. The study will measure the actual degree of change in patients' activity level and to evaluate the effect of the program on outcome measures such as length of stay.
Read the detailed description
The purpose of this study is to study implementation efficacy of an early mobilization program in a rural mixed surgical and medical ICU.
The aim of the study is to test whether a program of early mobilization training along with ongoing ABCEDF bundle implementation will change the following:
- early mobilization of ventilated patients in the ICU measured using accelerometer data as a primary measure along with other nurse reported data from the EMR
- ICU length of stay
- other clinical variable outlined in the design section
This study will have a pre- and post-implementation design. Baseline activity levels of eligible patients will be collected prospectively for approximately 3 months while staff is being trained and the details of the early mobilization program are being finalized. All eligible patients will wear an accelerometer while in the ICU. Length of ICU stay, total hospitalization, discharge disposition, and the occurrence of certain hospital-acquired complications will also be recorded as part of the baseline/current practice data. There will be a pause in data collection as the early mobilization program is incorporated into standard practice.
Data collection will resume approximately one month after the implementation of the program.
All eligible patients will wear an accelerometer to measure activity level while in the ICU. Length of ICU stay, total hospitalization, discharge disposition, and the occurrence of certain hospital-acquired complications will also be recorded. Other variables to be assessed include: ICU staffing costs, overall hospitalization costs, rate of patient falls, rate of staff injuries, level of exercise tolerance achieved by time of discharge.
- Being tested
- Activity level measurement by accelerometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity level measurement by accelerometerOther
Eligible patients will wear an accelerometer to measure activity levels while in the ICU.
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation cohort | These patients are being exposed to the current standard of care, which does include some early mobilization practices, but not a formalized program. Receives: Other: Activity level measurement by accelerometer | |
| post-implementation cohort | These patients will have been exposed to the fully executed early mobilization program. Receives: Other: Activity level measurement by accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity level
activity level during a patient's ICU admission will be measured by accelerometer
Measured: one week
Secondary outcomes (2)
Length of ICU admission
the amount of time spent as as an admitted patient to the ICU will be measured
Measured: one week
length of total hospitalization
the total amount of time spent as an inpatient for this episode of care will be measured
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Dec 2017
- Primary completion1 Dec 2020
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Mobilization of Mechanically Ventilated PatientsStudies 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bassett Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Riesenfeld, Bassett Healthcare
- Investigators
- Erik riesenfeld, MD, Principal investigator, Bassett Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329924
- Sponsor's protocol ID
- 2084
- Status last verified
- Mar 2023
- First submitted
- 31 Oct 2017
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Liberation: Does Enhanced Patient Mobilization Improve Outcomes?
- ClinicalTrials.gov ID
- NCT03329924
- Acronym / sponsor ID
- 2084
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Bassett HealthcareUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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 hypothesis of this study is that an early mobilization program coupled with organizational efforts to implement the ABCDEF bundle will increase the rate of ICU patient mobilization and decrease the ICU length of stay, but will not significantly affect patient mortality. Mobilization efforts will be done to improve patient care and the study will allow for measurement of the effects of implementation of this effort. The early mobilization program is being instituted as standard of care. The study will measure the actual degree of change in patients' activity level and to evaluate the effect of the program on outcome measures such as length of stay.
Detailed description
The purpose of this study is to study implementation efficacy of an early mobilization program in a rural mixed surgical and medical ICU.
The aim of the study is to test whether a program of early mobilization training along with ongoing ABCEDF bundle implementation will change the following:
- early mobilization of ventilated patients in the ICU measured using accelerometer data as a primary measure along with other nurse reported data from the EMR
- ICU length of stay
- other clinical variable outlined in the design section
This study will have a pre- and post-implementation design. Baseline activity levels of eligible patients will be collected prospectively for approximately 3 months while staff is being trained and the details of the early mobilization program are being finalized. All eligible patients will wear an accelerometer while in the ICU. Length of ICU stay, total hospitalization, discharge disposition, and the occurrence of certain hospital-acquired complications will also be recorded as part of the baseline/current practice data. There will be a pause in data collection as the early mobilization program is incorporated into standard practice.
Data collection will resume approximately one month after the implementation of the program.
All eligible patients will wear an accelerometer to measure activity level while in the ICU. Length of ICU stay, total hospitalization, discharge disposition, and the occurrence of certain hospital-acquired complications will also be recorded. Other variables to be assessed include: ICU staffing costs, overall hospitalization costs, rate of patient falls, rate of staff injuries, level of exercise tolerance achieved by time of discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation cohort | – | Other: Activity level measurement by accelerometerThese patients are being exposed to the current standard of care, which does include some early mobilization practices, but not a formalized program. |
| post-implementation cohort | – | Other: Activity level measurement by accelerometerThese patients will have been exposed to the fully executed early mobilization program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in a rural mixed surgical and medical ICU requiring mechanical ventilation will be included in this study
Key inclusion criteria (1 listed)
- - Patients in a rural mixed surgical and medical ICU requiring mechanical ventilation
Key exclusion criteria (8 listed)
- age less than 18
- Pregnant patients
- Cardiac surgery patients
- "boarding" patients in the ICU
- Patients expected to be extubated in less than 24 total hours (e.g. combative trauma patient intubated in order to complete workup),
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 |
|---|---|---|
| Activity level measurement by accelerometerEligible patients will wear an accelerometer to measure activity levels while in the ICU. | Other | Pre-implementation cohort, post-implementation cohort |
Primary outcome
Activity level
Time frame: one week
activity level during a patient's ICU admission will be measured by accelerometer
2 secondary outcomes
Length of ICU admission
Time frame: one week
length of total hospitalization
Time frame: one month
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 7 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Early Mobilization of Mechanically Ventilated Patients
Recruiting
Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients
Ventilator Dependent
Enrolling by invitationObservational study
The TEAM Long-Term Cohort Study (A Sub-study of TEAM(III))
Critically Ill, Mechanical Ventilation
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.
Erik riesenfeld, MD principal investigator
Bassett Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Mobilization of Mechanically Ventilated Patients, run by Bassett Healthcare at 1 site in United States.
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 1 inclusion and 8 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 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Activity level (time frame: one week). 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 7 Mar 2023.