ARDSNCT04581811
Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS)
A study testing Prolonged Proned Positioning and Traditional Proning Arm in people with ARDS and Covid19, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Prone positioning is one of the few therapies known to improve mortality in ARDS. Traditionally, patients are proned for 16 hours per 24 hour period. Some retrospective data suggests improvement may persist beyond 16 hours. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- ARDS, Covid19, Acute Hypoxemic Respiratory Failure
- What is being tested?
- Prolonged Proned Positioning and Traditional Proning Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2020to 20 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive COVID test Endotracheal Intubation P:F <150 within 1hours of inclusion on at least 60% FiO2, 10cmH20 PEEP Treating physician plans to implement prone positioning imminently Housed in the UAB MICU.
Who cannot join
- Pre-existing treatment limitation (e.g. DNR order) Prisoner Pregnant Female Children (<18 years old) Respiratory Failure felt to be caused primarily by something other than COVID-19 Mechanical ventilation for >48 hours prior to initiation of prone positioning Contraindication to proning Physician discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS): A Pilot Study
Prone positioning is one of the few therapies known to improve mortality in ARDS. Traditionally, patients are proned for 16 hours per 24 hour period. Some retrospective data suggests improvement may persist beyond 16 hours. We aim to perform a pilot study comparing traditional prone positioning to prolonged prone positioning in patients with COVID-induced ARDS.
- Conditions
- ARDS, Covid19, Acute Hypoxemic Respiratory Failure
- Being tested
- Prolonged Proned Positioning, Traditional Proning Arm
- Medical subject headings
- COVID-19, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Proned PositioningOther
Patients will be placed in the prone position for 24 hours followed by 8 hours supine for consecutive periods for the duration of the study period
Traditional Proning ArmOther
Patients will be placed in the prone position for 16 hours followed by 8 hours supine for consecutive periods for the duration of the study period
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Proning Arm | Experimental | Patients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study Receives: Other: Prolonged Proned Positioning |
| Traditional Proning Arm | Active comparator | Patients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study Receives: Other: Traditional Proning Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration in Prone Position
Time spent in the prone position of hours eligible for prone positioning
Measured: 96 hours
Secondary outcomes (11)
Change in P:F Ratio
Change in PaO2 on ABG to FiO2 ratio from immediately prior to initiation of prone positioning to end of study period
Measured: End of supine session on day 4
Change in Drive Pressure
Change in drive pressure from immediately prior to initiation of prone positioning to end of the study period
Measured: End of supine session on day 4
Unplanned Extubations
Number of unplanned extubations
Measured: End of supine session on day 4
Pressure Ulcers
Number of patients with pressure ulcers
Measured: End of supine session on day 4
Line Displacement
Number of displaced central venous line or arterial line
Measured: End of supine session on day 4
Vent Free Days
Number of days free from mechanical ventilation
Measured: 30 days
Mortality
Mortality at 30 days
Measured: 30 days
Rescue Interventions
Patients in which new initiation of inhaled pulmonary vasodilators, ECMO
Measured: 96 hours
Tracheostomy
Number of patients who have placement of tracheostomy
Measured: 30 days
ICU Free Days
Number of days not in ICU
Measured: 30 days
S:F Ratio
Ratio of SpO2 to FiO2
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start10 Nov 2020
- Primary completion20 Mar 2021
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Page, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581811
- Sponsor's protocol ID
- IRB-300005979
- Status last verified
- Mar 2022
- First submitted
- 7 Oct 2020
- Last updated
- 31 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Page DB, Vijaykumar K, Russell DW, Gandotra S, Chiles JW, Whitson MR, Dransfield MT. Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome: A Randomized Pilot Clinical Trial. Ann Am Thorac Soc. 2022 Apr;19(4):685-687. doi: 10.1513/AnnalsATS.202104-498RL. No abstract available.
PubMed 34491885
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS): A Pilot Study
- ClinicalTrials.gov ID
- NCT04581811
- Acronym / sponsor ID
- IRB-300005979
- Conditions
- ARDS, Covid19, Acute Hypoxemic Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Posted 31 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prone positioning is one of the few therapies known to improve mortality in ARDS. Traditionally, patients are proned for 16 hours per 24 hour period. Some retrospective data suggests improvement may persist beyond 16 hours. We aim to perform a pilot study comparing traditional prone positioning to prolonged prone positioning in patients with COVID-induced ARDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Proning Arm | Experimental | Other: Prolonged Proned PositioningPatients will receive 24 hours in the prone position followed by 8 hours in the supine position for the duration of the study |
| Traditional Proning Arm | Active comparator | Other: Traditional Proning ArmPatients will receive standard 16 hour prone positioning followed by 8 hours in the supine position for the duration of the study |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Positive COVID test Endotracheal Intubation P:F <150 within 1hours of inclusion on at least 60% FiO2, 10cmH20 PEEP Treating physician plans to implement prone positioning imminently Housed in the UAB MICU.
Key exclusion criteria (1 listed)
- Pre-existing treatment limitation (e.g. DNR order) Prisoner Pregnant Female Children (<18 years old) Respiratory Failure felt to be caused primarily by something other than COVID-19 Mechanical ventilation for >48 hours prior to initiation of prone positioning Contraindication to proning Physician discretion
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 |
|---|---|---|
| Prolonged Proned PositioningPatients will be placed in the prone position for 24 hours followed by 8 hours supine for consecutive periods for the duration of the study period | Other | Prolonged Proning Arm |
| Traditional Proning ArmPatients will be placed in the prone position for 16 hours followed by 8 hours supine for consecutive periods for the duration of the study period | Other | Traditional Proning Arm |
Primary outcome
Duration in Prone Position
Time frame: 96 hours
Time spent in the prone position of hours eligible for prone positioning
11 secondary outcomes
Change in P:F Ratio
Time frame: End of supine session on day 4
Change in Drive Pressure
Time frame: End of supine session on day 4
Unplanned Extubations
Time frame: End of supine session on day 4
Pressure Ulcers
Time frame: End of supine session on day 4
Line Displacement
Time frame: End of supine session on day 4
Vent Free Days
Time frame: 30 days
Mortality
Time frame: 30 days
Rescue Interventions
Time frame: 96 hours
Tracheostomy
Time frame: 30 days
ICU Free Days
Time frame: 30 days
S:F Ratio
Time frame: 96 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34491885Page DB, Vijaykumar K, Russell DW, Gandotra S, Chiles JW, Whitson MR, Dransfield MT. Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome: A Randomized Pilot Clinical Trial. Ann Am Thorac Soc. 2022 Apr;19(4):685-687. doi: 10.1513/AnnalsATS.202104-498RL. No abstract available.
- Individual participant dataSharing planned: No
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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 Prolonged Proned Positioning and Traditional Proning Arm in people with ARDS and Covid19, run by University of Alabama at Birmingham 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 1 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 31 Mar 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?
Yes. Results are posted in the registry (first posted 31 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Duration in Prone Position (time frame: 96 hours). 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 NCT04581811, which also lists 1 linked publication.
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 31 Mar 2022.