Immobility and Weakness Associated With Long Intensive Care Unit StaysNCT01295541
Early Progressive Mobility in the CVICU: Assessing Current Status
An observational study of Immobility and Weakness Associated With Long Intensive Care Unit Stays, run by Hill-Rom at 1 site in United States.
Trial summary
The current study is proposed to assess the frequency and type of progressive mobility procedures currently performed in the CVICU The study will evaluate the type and frequency of progressive mobility orders, whether or not progressive mobility steps are being taken by the nursing teams, define what steps patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immobility and Weakness Associated With Long Intensive Care Unit Stays
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2010
- 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: The study population will consist of patients admitted to the CV-Intensive Care Unit.
Who may be able to join
- Patient is ≥ 18 years old.
- Patient has been admitted to the ICU for less than 3 days prior to study enrollment
- Patients require mechanical ventilation for >48 hours
Who cannot join
- Mobilization is contraindicated by Patient's condition. Such as hip fractures or other injury that would impede standing posture.
- Patient weighs less than 70 pounds or more than 440 pounds
- Mobilization is contraindicated by patient's condition or physician's orders exist that prevent the patient from participating in the mobility protocol.
- Patient was unable to walk or stand without assistance prior to ICU admission.
- Patient was cognitively unable to follow verbal commands prior to ICU admission.
- Patients current diagnosis includes acute stroke with neurologic impairment
Show all 9Show fewer
- Patient's current diagnosis includes drug overdose.
- Patient has "Do not resuscitate" orders and/or is at an end stage terminal disease state.
- Patient requires a specialty bed or mattress.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Central Georgia
Macon, Georgia, 31201
About this study
The current study is proposed to assess the frequency and type of progressive mobility procedures currently performed in the CVICU The study will evaluate the type and frequency of progressive mobility orders, whether or not progressive mobility steps are being taken by the nursing teams, define what steps patients are receiving, and record time to first weight bearing. Other outcome measures will be the days of required mechanical ventilation, and current ICU length of stay and cost to treat.
Read the detailed description
This will be a descriptive 4 month study of standard care practice. Patients who meet the inclusion / exclusion criteria for study will be enrolled (Waiver of informed consent is requested) and followed for a maximum of 28 days. The type and frequency of progressive mobility orders, whether or not progressive mobility steps are being taken by the nursing teams, define what steps patients are receiving, and record time to first weight bearing will be recorded. Weight bearing will be defined as standing for at least 1 minute. ICU LOS, Ventilator Days will be assessed at ICU discharge for study patients. Barriers to PM procedures will also be assessed.
- Keywords
- ICU LOS, Progressive Mobility, Deconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 4 months of observation | CVICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
First OOB
The ICU day that the patient is able to stand for at least 1 minute will be assessed.
Measured: Days
Secondary outcomes (2)
ICU LOS
Length of stay will be measured
Measured: Days
Type and Frequency of PM orders
The type and frequency of Progressive mobility orders will be assessed
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immobility and Weakness Associated With Long Intensive Care Unit StaysStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Leslie Culpepper, MSN, RN, Principal investigator, The Medical Cneter of Central Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295541
- Sponsor's protocol ID
- CR-2009-05a
- Status last verified
- Feb 2011
- First submitted
- 6 Jul 2010
- Last updated
- 14 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Progressive Mobility in the CVICU: Assessing Current Status
- ClinicalTrials.gov ID
- NCT01295541
- Acronym / sponsor ID
- CR-2009-05a
- Keywords
- ICU LOS, Progressive Mobility, Deconditioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Feb 2011 (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 current study is proposed to assess the frequency and type of progressive mobility procedures currently performed in the CVICU The study will evaluate the type and frequency of progressive mobility orders, whether or not progressive mobility steps are being taken by the nursing teams, define what steps patients are receiving, and record time to first weight bearing. Other outcome measures will be the days of required mechanical ventilation, and current ICU length of stay and cost to treat.
Detailed description
This will be a descriptive 4 month study of standard care practice. Patients who meet the inclusion / exclusion criteria for study will be enrolled (Waiver of informed consent is requested) and followed for a maximum of 28 days. The type and frequency of progressive mobility orders, whether or not progressive mobility steps are being taken by the nursing teams, define what steps patients are receiving, and record time to first weight bearing will be recorded. Weight bearing will be defined as standing for at least 1 minute. ICU LOS, Ventilator Days will be assessed at ICU discharge for study patients. Barriers to PM procedures will also be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4 months of observation | – | –CVICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients admitted to the CV-Intensive Care Unit.
Key inclusion criteria (3 listed)
- Patient is ≥ 18 years old.
- Patient has been admitted to the ICU for less than 3 days prior to study enrollment
- Patients require mechanical ventilation for >48 hours
Key exclusion criteria (9 listed)
- Mobilization is contraindicated by Patient's condition. Such as hip fractures or other injury that would impede standing posture.
- Patient weighs less than 70 pounds or more than 440 pounds
- Mobilization is contraindicated by patient's condition or physician's orders exist that prevent the patient from participating in the mobility protocol.
- Patient was unable to walk or stand without assistance prior to ICU admission.
- Patient was cognitively unable to follow verbal commands prior to ICU admission.
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
First OOB
Time frame: Days
The ICU day that the patient is able to stand for at least 1 minute will be assessed.
2 secondary outcomes
ICU LOS
Time frame: Days
Type and Frequency of PM orders
Time frame: Daily
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 14 Feb 2011.
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.
Leslie Culpepper, MSN, RN principal investigator
The Medical Cneter of Central Georgia
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 Immobility and Weakness Associated With Long Intensive Care Unit Stays, run by Hill-Rom 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 3 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 14 Feb 2011. 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?
First OOB (time frame: Days). 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 14 Feb 2011.