Respiratory FailureNCT02533622
Holy Name Progressive Mobility in the ICU
An observational study of Respiratory Failure, run by Hill-Rom at 1 site in United States.
Trial summary
Despite the known complications of immobility for ICU patients, compliance to mobility protocols is lacking in many institutions. Significant barriers have been described to compliance to up in chair and weight bearing orders in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2013
- 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: Adult patients admitted to the Medical ICU
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
- Patient has an unstable spinal injury.
- Patient weighs less than 70 pounds or more than 450 pounds
- Mobilization is contraindicated by Patient's condition. Such as hip fractures or other injury that would impede standing posture.
- Patient was unable to walk without assistance prior to ICU admission.
- Patient was cognitively impaired prior to ICU admission.
- Patient has experienced acute stroke with neurologic impairment
Show all 9Show fewer
- Patient's primary diagnosis is drug overdose.
- Patient has Comfort Care Measures/End of Life orders and/or is at an end stage terminal disease state.
- Patient requires a bed other than the standard care bed for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study Of The Impact Of Total Care® Bed System Combined With The Liko Lift to Facilitate Early Progressive Mobility Compliance and Associated Clinical and Financial Outcomes.
Despite the known complications of immobility for ICU patients, compliance to mobility protocols is lacking in many institutions. Significant barriers have been described to compliance to up in chair and weight bearing orders in the ICU. Recent studies indicate that if progressive mobility is performed for acutely ill ICU patients they may have a reduced ICU length of stay, reduced overall hospital length of stay, incur lower hospital costs, and reduce the rate of some medical complications and increase functionality post ICU discharge.
The current protocol seeks to understand whether or not the TotalCare® P500 Bed System and the Liko Lift can remove some of the barriers associated with progressive mobility compliance.
Read the detailed description
This study is designed as a process improvement program to increase compliance to a progressive mobility protocol in an ICU setting. The first part of the study (4-6 months period depending on time required for implementation) will document 1st day of weight bearing as well as the secondary outcome measures of this of progressive mobility protocol as are currently in place in the ICU for patients that meet the inclusion/exclusion criteria. Ease of progressive mobility implementation will be assessed. Appropriate education will be performed as to the importance of progressive mobility.
The second part of the study (4-6 months) will document the same outcomes, however, the progressive mobility protocol will now include a standardized process using the Total Care® P500 Bed System combined with the Liko Lift. During the second study period, patients will progress in a stepped protocol (see section 6.2) beginning with head of bed (HOB) at 30o to initiate orthostatic stress three times daily with increasing time intervals, then increasing HOB angle, time, and finally to standing and bearing weight. The Total Care® P500 Bed System and the Liko Lift will be placed on all participating units for the duration of the second phase of the study.
Compliance to specific outcome measures again will be measured as well as the ease of Progressive Mobility implementation. The total study period will be 8-12 months (allowing time for bed delivery and education).
Patients who meet the inclusion/exclusion criteria for study will be enrolled. Protocol based "up in chair" and "standing" orders will be followed for compliance, and length of actual sitting in full chair or standing. If patients undergo "full chair" in the bed, this will be considered "up in chair." Time/days to first weight bearing, as defined as weight bearing in a standing position for at least 1 minute will be documented. ICU LOS, Ventilator Days will be assessed at ICU discharge for study patients. Nursing satisfaction and ease of PM protocol adherence surveys will be performed after each study period and will assess both standard of care and Total Care® bed/Liko lift systems.
- Conditions
- Respiratory Failure
- Keywords
- progressive mobility
- Medical subject headings
- Respiratory Insufficiency
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 |
|---|---|---|
| Standard of care | Patients admitted to the ICU will receive current standard of care related to mobility | |
| Progressive mobility | patients admitted to the ICU will receive mobility per Progressive Mobility protocol using TotalCare beds and lifts |
What is being measured
The primary outcome is the main question the study is designed to answer.
First out of bed, which is to be defined as the first time that a patient stands whether assisted or not for > 1 minute.
Measured: at ICU discharge (current avg LOS = 6 days)
Secondary outcomes (7)
ICU length of stay
Measured: at ICU discharge (current avg LOS = 6 days)
Days of Mechanical Ventilation assessed as time to extubation. Extubation is to be defined as the time when the ET tube is removed from the airway
Measured: at ICU discharge (current avg LOS = 6 days)
Compliance with, Number and Duration of Up in Chair episodes. Patients will be considered compliant if they complete 100% of prescribed episodes.
Measured: at ICU discharge (current avg LOS = 6 days)
ICU readmission rate (within 30 days)
Measured: at ICU discharge (current avg LOS = 6 days)
Incidence of nosocomial pressure ulcers and change in existing pressure ulcers
Measured: at ICU discharge (current avg LOS = 6 days)
Nursing satisfaction and ease of use for each bed system for the purpose of mobilizing patients
Measured: at ICU discharge (current avg LOS = 6 days)
Financial outcomes will be calculated if any reduction in days / hours of mechanical ventilation and days of ICU admission occur
Measured: at ICU discharge (current avg LOS = 6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startJan 2011
- Primary completionNov 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill-Rom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary J Tracy, RN, MSN, Principal investigator, Holy Name Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533622
- Sponsor's protocol ID
- QI-2010-05
- Status last verified
- Aug 2015
- First submitted
- 22 Mar 2012
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Of The Impact Of Total Care® Bed System Combined With The Liko Lift to Facilitate Early Progressive Mobility Compliance and Associated Clinical and Financial Outcomes.
- ClinicalTrials.gov ID
- NCT02533622
- Acronym / sponsor ID
- QI-2010-05
- Conditions
- Respiratory Failure
- Keywords
- progressive mobility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hill-RomIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 27 Aug 2015 (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 the known complications of immobility for ICU patients, compliance to mobility protocols is lacking in many institutions. Significant barriers have been described to compliance to up in chair and weight bearing orders in the ICU. Recent studies indicate that if progressive mobility is performed for acutely ill ICU patients they may have a reduced ICU length of stay, reduced overall hospital length of stay, incur lower hospital costs, and reduce the rate of some medical complications and increase functionality post ICU discharge.
The current protocol seeks to understand whether or not the TotalCare® P500 Bed System and the Liko Lift can remove some of the barriers associated with progressive mobility compliance.
Detailed description
This study is designed as a process improvement program to increase compliance to a progressive mobility protocol in an ICU setting. The first part of the study (4-6 months period depending on time required for implementation) will document 1st day of weight bearing as well as the secondary outcome measures of this of progressive mobility protocol as are currently in place in the ICU for patients that meet the inclusion/exclusion criteria. Ease of progressive mobility implementation will be assessed. Appropriate education will be performed as to the importance of progressive mobility.
The second part of the study (4-6 months) will document the same outcomes, however, the progressive mobility protocol will now include a standardized process using the Total Care® P500 Bed System combined with the Liko Lift. During the second study period, patients will progress in a stepped protocol (see section 6.2) beginning with head of bed (HOB) at 30o to initiate orthostatic stress three times daily with increasing time intervals, then increasing HOB angle, time, and finally to standing and bearing weight. The Total Care® P500 Bed System and the Liko Lift will be placed on all participating units for the duration of the second phase of the study.
Compliance to specific outcome measures again will be measured as well as the ease of Progressive Mobility implementation. The total study period will be 8-12 months (allowing time for bed delivery and education).
Patients who meet the inclusion/exclusion criteria for study will be enrolled. Protocol based "up in chair" and "standing" orders will be followed for compliance, and length of actual sitting in full chair or standing. If patients undergo "full chair" in the bed, this will be considered "up in chair." Time/days to first weight bearing, as defined as weight bearing in a standing position for at least 1 minute will be documented. ICU LOS, Ventilator Days will be assessed at ICU discharge for study patients. Nursing satisfaction and ease of PM protocol adherence surveys will be performed after each study period and will assess both standard of care and Total Care® bed/Liko lift systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | – | –Patients admitted to the ICU will receive current standard of care related to mobility |
| Progressive mobility | – | –patients admitted to the ICU will receive mobility per Progressive Mobility protocol using TotalCare beds and lifts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the Medical ICU
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)
- Patient has an unstable spinal injury.
- Patient weighs less than 70 pounds or more than 450 pounds
- Mobilization is contraindicated by Patient's condition. Such as hip fractures or other injury that would impede standing posture.
- Patient was unable to walk without assistance prior to ICU admission.
- Patient was cognitively impaired 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 out of bed, which is to be defined as the first time that a patient stands whether assisted or not for > 1 minute.
Time frame: at ICU discharge (current avg LOS = 6 days)
7 secondary outcomes
ICU length of stay
Time frame: at ICU discharge (current avg LOS = 6 days)
Days of Mechanical Ventilation assessed as time to extubation. Extubation is to be defined as the time when the ET tube is removed from the airway
Time frame: at ICU discharge (current avg LOS = 6 days)
Compliance with, Number and Duration of Up in Chair episodes. Patients will be considered compliant if they complete 100% of prescribed episodes.
Time frame: at ICU discharge (current avg LOS = 6 days)
ICU readmission rate (within 30 days)
Time frame: at ICU discharge (current avg LOS = 6 days)
Incidence of nosocomial pressure ulcers and change in existing pressure ulcers
Time frame: at ICU discharge (current avg LOS = 6 days)
Nursing satisfaction and ease of use for each bed system for the purpose of mobilizing patients
Time frame: at ICU discharge (current avg LOS = 6 days)
Financial outcomes will be calculated if any reduction in days / hours of mechanical ventilation and days of ICU admission occur
Time frame: at ICU discharge (current avg LOS = 6 days)
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 27 Aug 2015.
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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.
Mary J Tracy, RN, MSN principal investigator
Holy Name Hospital
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 Respiratory Failure, 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 27 Aug 2015. 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 out of bed, which is to be defined as the first time that a patient stands whether assisted or not for > 1 minute. (time frame: at ICU discharge (current avg LOS = 6 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 27 Aug 2015.