Respiratory FailureNCT01777035
Early Mobilization in the ICU
A study testing early PT OT in people with Respiratory Failure, run by University of Chicago at 1 site in United States.
Trial summary
To study all ICU patients with an independent baseline functional status , who experience a critical illness requiring intubation and mechanical ventilation evaluating long-term cognitive and executive function and long term cost effectiveness in survivors who required mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- early PT OT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2011to 14 Jan 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intubated and MV > 24, < 96 hours
- Baseline Barthel Index Functional Score > 70, functional at home
Who cannot join
- Rapidly changing neurological conditions (e.g. stroke)
- Cardiac arrest as cause for respiratory failure
- Elevated intracranial pressure
- Pregnancy (due to inability to provide continuous fetal monitoring)
- Terminal condition (life expectancy < 6 months)
- Traumatic brain injury, multiple limb fractures, pelvic fractures,
- Severe chronic pain syndrome on admission
Trial locations and contacts
1 site in 1 country.
About this study
To study all ICU patients with an independent baseline functional status , who experience a critical illness requiring intubation and mechanical ventilation evaluating long-term cognitive and executive function and long term cost effectiveness in survivors who required mechanical ventilation.
Read the detailed description
Immediate mobilization of mechanically ventilated (MV) ICU patients is not part of usual care in the U.S. or internationally. Our previous work supports that early mobilization through physical and occupational therapy for ICU patients on the ventilator can help them experience less delirium, spend less time in the ICU and hospital, and become more independent when they leave. To advance our knowledge in this area, large longitudinal studies are needed to understand the long-term physical, cognitive and mental health status of survivors and to test how specific ICU therapies may affect these outcomes.
- Conditions
- Respiratory Failure
- Being tested
- early PT OT
- Keywords
- mechanical ventilation, physical therapy, occupational therapy, ICU acquired weakness, critical illness myopathy
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early PT OTOther
- Passive range of motion (ROM) in pts who remain unresponsive despite sedative interruption.
- active assisted ROM in supine position.
- treatment is advanced to bed mobility activities
- sitting balance activities followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks.
- progression to transfer training, and finally pre-gait training and ambulation.
- progression of activities dependent on patient tolerance and stability
- therapy sessions continue on a daily basis throughout hospital stay until return to prior level of function or is discharged.
| Study group | Role | What they receive |
|---|---|---|
| Early physical therapy(PT) occupational therapy (OT) | Experimental | Early PT OT assessments begin on first day of study. Therapy delivered by a team consisting of physical and occupational therapists and coordinated with daily sedative interruption Receives: Other: early PT OT |
| standard care | No intervention | PT OT delivered as ordered by the primary ICU team |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of cognitive impairment
Measured: within the first 30 days after ICU admission
presence of cognitive impairment
Measured: up to 1 year post discharge
Secondary outcomes (3)
cognitive test score
includes variables
- orientation
- attention
- memory
- reasoning
- executive function
Measured: up to 1 year post discharge
institution free days
number of days not requiring inpatient admission
Measured: up to 1 yr post discharge
Insulin Resistance
Measuring insulin resistance and glycemic control in patients who are still mechanically ventilated on third day of enrollment in the study
Measured: day 3 of mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study start19 Jul 2011
- Primary completion14 Jan 2022
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John P Kress, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777035
- Sponsor's protocol ID
- 11-0218
- Status last verified
- Feb 2022
- First submitted
- 16 Jan 2013
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Patel BK, Wolfe KS, Patel SB, Dugan KC, Esbrook CL, Pawlik AJ, Stulberg M, Kemple C, Teele M, Zeleny E, Hedeker D, Pohlman AS, Arora VM, Hall JB, Kress JP. Effect of early mobilisation on long-term cognitive impairment in critical illness in the USA: a randomised controlled trial. Lancet Respir Med. 2023 Jun;11(6):563-572. doi: 10.1016/S2213-2600(22)00489-1. Epub 2023 Jan 21.
PubMed 36693400Wolfe KS, Patel BK, MacKenzie EL, Giovanni SP, Pohlman AS, Churpek MM, Hall JB, Kress JP. Impact of Vasoactive Medications on ICU-Acquired Weakness in Mechanically Ventilated Patients. Chest. 2018 Oct;154(4):781-787. doi: 10.1016/j.chest.2018.07.016. Epub 2018 Sep 11.
PubMed 30217640
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mobilization in the ICU
- ClinicalTrials.gov ID
- NCT01777035
- Acronym / sponsor ID
- 11-0218
- Conditions
- Respiratory Failure
- Keywords
- mechanical ventilation, physical therapy, occupational therapy, ICU acquired weakness, critical illness myopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 19 Jul 2011 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 28 Jan 2013 (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.
To study all ICU patients with an independent baseline functional status , who experience a critical illness requiring intubation and mechanical ventilation evaluating long-term cognitive and executive function and long term cost effectiveness in survivors who required mechanical ventilation.
Detailed description
Immediate mobilization of mechanically ventilated (MV) ICU patients is not part of usual care in the U.S. or internationally. Our previous work supports that early mobilization through physical and occupational therapy for ICU patients on the ventilator can help them experience less delirium, spend less time in the ICU and hospital, and become more independent when they leave. To advance our knowledge in this area, large longitudinal studies are needed to understand the long-term physical, cognitive and mental health status of survivors and to test how specific ICU therapies may affect these outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early physical therapy(PT) occupational therapy (OT) | Experimental | Other: early PT OTEarly PT OT assessments begin on first day of study. Therapy delivered by a team consisting of physical and occupational therapists and coordinated with daily sedative interruption |
| standard care | No intervention | –PT OT delivered as ordered by the primary ICU team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Intubated and MV > 24, < 96 hours
- Baseline Barthel Index Functional Score > 70, functional at home
Key exclusion criteria (7 listed)
- Rapidly changing neurological conditions (e.g. stroke)
- Cardiac arrest as cause for respiratory failure
- Elevated intracranial pressure
- Pregnancy (due to inability to provide continuous fetal monitoring)
- Terminal condition (life expectancy < 6 months)
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 |
|---|---|---|
| early PT OT1. Passive range of motion (ROM) in pts who remain unresponsive despite sedative interruption. 2. active assisted ROM in supine position. 3. treatment is advanced to bed mobility activities 4. sitting balance activities followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks. 5. progression to transfer training, and finally pre-gait training and ambulation. 6. progression of activities dependent on patient tolerance and stability 7. therapy sessions continue on a daily basis throughout hospital stay until return to prior level of function or is discharged. | Other | Early physical therapy(PT) occupational therapy (OT) |
Primary outcome
presence of cognitive impairment
Time frame: within the first 30 days after ICU admission
presence of cognitive impairment
Time frame: up to 1 year post discharge
3 secondary outcomes
cognitive test score
Time frame: up to 1 year post discharge
institution free days
Time frame: up to 1 yr post discharge
Insulin Resistance
Time frame: day 3 of mechanical ventilation
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 21 Feb 2022.
- Derived from this study: PubMed 36693400Patel BK, Wolfe KS, Patel SB, Dugan KC, Esbrook CL, Pawlik AJ, Stulberg M, Kemple C, Teele M, Zeleny E, Hedeker D, Pohlman AS, Arora VM, Hall JB, Kress JP. Effect of early mobilisation on long-term cognitive impairment in critical illness in the USA: a randomised controlled trial. Lancet Respir Med. 2023 Jun;11(6):563-572. doi: 10.1016/S2213-2600(22)00489-1. Epub 2023 Jan 21.
- Derived from this study: PubMed 30217640Wolfe KS, Patel BK, MacKenzie EL, Giovanni SP, Pohlman AS, Churpek MM, Hall JB, Kress JP. Impact of Vasoactive Medications on ICU-Acquired Weakness in Mechanically Ventilated Patients. Chest. 2018 Oct;154(4):781-787. doi: 10.1016/j.chest.2018.07.016. Epub 2018 Sep 11.
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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.
John P Kress, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early PT OT in people with Respiratory Failure, run by University of Chicago 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 2 inclusion and 7 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 21 Feb 2022. 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?
presence of cognitive impairment (time frame: within the first 30 days after ICU admission). The study lists 2 primary outcomes in all. 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 NCT01777035, which also lists 2 linked publications.
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 21 Feb 2022.