COVID-19 Acute Respiratory Distress SyndromeNCT05109624
Is Prolonged Period of Prone Position Effective and Safe in Mechanically Ventilated Patients With SARS-COV-2?
A study testing prolonged prone position ventilation in people with COVID-19 Acute Respiratory Distress Syndrome, run by Ain Shams University at 1 site in Egypt.
Trial summary
the aim of the study is to assess safety and efficacy of prone position ventilation beyond the usual 16 hrs in patients with SARS-COV-2 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- prolonged prone position ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 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
- - American Society of Anesthesiologists (ASA) physical status II- III.
- Sex (male and females).
- Age 18 -80 years.
- Sever adult respiratory distress (ARDS) (defined as a PaO2:FiO2 ratio of <150 mm Hg, with a fraction of inspired oxygen (FiO2) of ≥0.6, a positive end expiratory pressure (PEEP) of ≥5 CmH2O, and a tidal volume of 6 ml/Kg of predicted body weight
- mechanical ventilation for less than 36 hours
Who cannot join
- - Contraindication for prone positioning
- increased intracranial tension.
- face trauma or surgery.
- Recent Deep venous thrombosis
- Unstable spine, femur, or pelvic fractures
- Mean arterial pressure < 65 mm Hg
Show all 10Show fewer
- Pregnant women
- Pneumothorax
- Prone positioning before inclusion
- Those returned to supine position before completing the session time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Prolonged Period of Prone Position Effective and Safe in Mechanically Ventilated Patients With SARS-COV-2? A Randomized Clinical Trial
the aim of the study is to assess safety and efficacy of prone position ventilation beyond the usual 16 hrs in patients with SARS-COV-2
- Being tested
- prolonged prone position ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prolonged prone position ventilationProcedure or surgery
patients mechanically ventilated with SARS COV 2 will be subjected to a longer than usual period of prone position ventilation
| Study group | Role | What they receive |
|---|---|---|
| group(A) control group | No intervention | pronation cycles each last for 16 hours every 24 hours |
| group(B) | Active comparator | pronation cycles each last for 24 hours followed by 6 hours supine position Receives: Procedure: prolonged prone position ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of successful weaning
how many patients successfully extubated, hospital survival, ICU stay
Measured: 28 days
Incidence of complications
Incidence of facial edema, pressure wounds, lines disconnections, hemodynamic instability
Measured: 28 days
Secondary outcomes (1)
Efficacy of oxygenation
mean value of change in PaO2/FiO2 ratio and static lung compliance before and after 3 successive proning cycles
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Oct 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 COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Fouad, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109624
- Sponsor's protocol ID
- FMASU R 160 / 2021
- Status last verified
- Feb 2022
- First submitted
- 3 Nov 2021
- Last updated
- 17 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Prolonged Period of Prone Position Effective and Safe in Mechanically Ventilated Patients With SARS-COV-2? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05109624
- Acronym / sponsor ID
- FMASU R 160 / 2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 5 Nov 2021 (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 aim of the study is to assess safety and efficacy of prone position ventilation beyond the usual 16 hrs in patients with SARS-COV-2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group(A) control group | No intervention | –pronation cycles each last for 16 hours every 24 hours |
| group(B) | Active comparator | Procedure: prolonged prone position ventilationpronation cycles each last for 24 hours followed by 6 hours supine position |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - American Society of Anesthesiologists (ASA) physical status II- III.
- Sex (male and females).
- Age 18 -80 years.
- Sever adult respiratory distress (ARDS) (defined as a PaO2:FiO2 ratio of <150 mm Hg, with a fraction of inspired oxygen (FiO2) of ≥0.6, a positive end expiratory pressure (PEEP) of ≥5 CmH2O, and a tidal volume of 6 ml/Kg of predicted body weight
- mechanical ventilation for less than 36 hours
Key exclusion criteria (10 listed)
- - Contraindication for prone positioning
- Those returned to supine position before completing the session time
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 prone position ventilationpatients mechanically ventilated with SARS COV 2 will be subjected to a longer than usual period of prone position ventilation | Procedure or surgery | group(B) |
Primary outcome
rate of successful weaning
Time frame: 28 days
how many patients successfully extubated, hospital survival, ICU stay
Incidence of complications
Time frame: 28 days
Incidence of facial edema, pressure wounds, lines disconnections, hemodynamic instability
1 secondary outcome
Efficacy of oxygenation
Time frame: 28 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 17 Feb 2022.
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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 prone position ventilation in people with COVID-19 Acute Respiratory Distress Syndrome, run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 10 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 17 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 Egypt. 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?
rate of successful weaning (time frame: 28 days). 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?
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 17 Feb 2022.