ARDS, HumanARISENCT04612608
Assessing the Role of Inclined Positioning in Acute Respiratory Distress Syndrome Patients Recovery
A study testing upright bed in people with ARDS, Human, run by Peter Morris at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of intermittent, nearly vertical, patient positioning in a specialized upright bed, on outcomes of mechanically ventilated patients with acute respiratory distress syndrome (ARDS) who are in the ICU. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS, Human
- What is being tested?
- upright bed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2021to 1 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Berlin criteria ARDS
Who cannot join
- ARDS greater than 72 hours
- Neurologic disease known to prolong weaning
- Pregnancy
- Known diagnosis of pulmonary fibrosis
- Implanted cardiac pacer/defibrillator
- prisoner
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effect of intermittent, nearly vertical, patient positioning in a specialized upright bed, on outcomes of mechanically ventilated patients with acute respiratory distress syndrome (ARDS) who are in the ICU.
Read the detailed description
The purpose of this study is to determine the effect of intermittent, nearly vertical, patient positioning in a specialized upright bed, on outcomes of mechanically ventilated patients with acute respiratory distress syndrome (ARDS) who are in the ICU. This study is a prospective, non-blinded, feasibility, randomized study of ARDS patients, who will be randomized into two treatment groups. One treatment arm will deliver scheduled sessions of upright bed positioning (study intervention), while the other treatment arm receives routine bed position care (care provided exclusively with the bed in the supine position). ICU Practitioners know that positional changes improve clinical outcomes when turning patients from supine to prone (back to belly); however, other positional changes including upright positioning are far less studied. It is well known that in ARDS patients who become proned, an improvement in aeration occurs in the dorsal lung regions (prone positioning has been shown to reduce ARDS mortality). Thus the investigators predict that in this study, the upright positioning holds the potential to further recruit collapsed lung areas. Augmentation of aerated lung while in the upright position is expected to increase the highest value measured per ventilator day of the respiratory system compliance in the upright bed position arm, in a greater fashion than the highest value measured per ventilator day of daily total respiratory system compliance for the usual care arm.
- Conditions
- ARDS, Human
- Being tested
- upright bed
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upright bedProcedure or surgery
moving the bed into an upright position
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual Care |
| Intervention | Active comparator | Intervention arm Receives: Procedure: upright bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
highest value per day of mechanical ventilation of total respiratory system compliance
total respiratory system compliance measured 4x daily for each day of mechanical ventilation
Measured: from the day of randomization, every day of mechanical ventilation until death or liberation from mechanical ventilation up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start26 May 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention arm will undergo a protocol of 4x per day bed elevation to 60 degrees for 30 minutes.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Morris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Morris, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612608
- Sponsor's protocol ID
- 60328
- Acronym
- ARISE
- Status last verified
- Apr 2022
- First submitted
- 6 Oct 2020
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will plan to make individual participant data (IPD) available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Role of Inclined Positioning in Acute Respiratory Distress Syndrome Patients Recovery
- ClinicalTrials.gov ID
- NCT04612608
- Acronym / sponsor ID
- ARISE / 60328
- Conditions
- ARDS, Human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Peter MorrisUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 3 Nov 2020 (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 purpose of this study is to determine the effect of intermittent, nearly vertical, patient positioning in a specialized upright bed, on outcomes of mechanically ventilated patients with acute respiratory distress syndrome (ARDS) who are in the ICU.
Detailed description
The purpose of this study is to determine the effect of intermittent, nearly vertical, patient positioning in a specialized upright bed, on outcomes of mechanically ventilated patients with acute respiratory distress syndrome (ARDS) who are in the ICU. This study is a prospective, non-blinded, feasibility, randomized study of ARDS patients, who will be randomized into two treatment groups. One treatment arm will deliver scheduled sessions of upright bed positioning (study intervention), while the other treatment arm receives routine bed position care (care provided exclusively with the bed in the supine position). ICU Practitioners know that positional changes improve clinical outcomes when turning patients from supine to prone (back to belly); however, other positional changes including upright positioning are far less studied. It is well known that in ARDS patients who become proned, an improvement in aeration occurs in the dorsal lung regions (prone positioning has been shown to reduce ARDS mortality). Thus the investigators predict that in this study, the upright positioning holds the potential to further recruit collapsed lung areas. Augmentation of aerated lung while in the upright position is expected to increase the highest value measured per ventilator day of the respiratory system compliance in the upright bed position arm, in a greater fashion than the highest value measured per ventilator day of daily total respiratory system compliance for the usual care arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention arm will undergo a protocol of 4x per day bed elevation to 60 degrees for 30 minutes.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual Care |
| Intervention | Active comparator | Procedure: upright bedIntervention arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Berlin criteria ARDS
Key exclusion criteria (6 listed)
- ARDS greater than 72 hours
- Neurologic disease known to prolong weaning
- Pregnancy
- Known diagnosis of pulmonary fibrosis
- Implanted cardiac pacer/defibrillator
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 |
|---|---|---|
| upright bedmoving the bed into an upright position | Procedure or surgery | Intervention |
Primary outcome
highest value per day of mechanical ventilation of total respiratory system compliance
Time frame: from the day of randomization, every day of mechanical ventilation until death or liberation from mechanical ventilation up to day 28
total respiratory system compliance measured 4x daily for each day 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 12 Apr 2022.
- Individual participant dataSharing planned: Yes. Investigators will plan to make individual participant data (IPD) available to other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upright bed in people with ARDS, Human, run by Peter Morris 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 6 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 12 Apr 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?
highest value per day of mechanical ventilation of total respiratory system compliance (time frame: from the day of randomization, every day of mechanical ventilation until death or liberation from mechanical ventilation up to day 28). 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 12 Apr 2022.