Covid19NCT04924816
Awake Prone Position in Patients With COVID-19
An observational study of Covid19, run by Brazilian Institute of Higher Education of Censa at 1 site in Brazil.
Trial summary
Although prone position is widely used in awake patients with COVID-19 associated with supplemental oxygenation, high flow nasal catheter, or noninvasive ventilation, few studies are attesting to its real benefits on physiological variables or intubation rate. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Awake prone position
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Jul 2020to 26 Dec 2020
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a confirmed diagnosis of COVID-19, spontaneously ventilating, dependent on supplemental oxygen.
Who may be able to join
None listed.
Who cannot join
- hemodynamic instability, severe obesity, or who were unable to tolerate and cooperate with the performance of PP
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Luciano M Chicayban
Campos dos Goytacazes, Rio de Janeiro, 28015150
About this study
Official title: Evaluation of the Response to the Awake Prone Position in Patients With COVID-19
Although prone position is widely used in awake patients with COVID-19 associated with supplemental oxygenation, high flow nasal catheter, or noninvasive ventilation, few studies are attesting to its real benefits on physiological variables or intubation rate. Awake patients dependent on supplemental oxygen may have different responses to PP about peripheral oxygen saturation, heart rate, and respiratory rate. Such responses may be permanent, transient, or even absent. We believe that the response to PP can be a predictor of the need for admission to the ICU. This study aimed to evaluate the acute effects of different types of response to the prone position in patients awake with COVID-19.
- Conditions
- Covid19
- Being tested
- Awake prone position
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake prone positionProcedure or surgery
The prone position in awake patients consists of asking the patient to voluntarily change to prone position, in a swimmer's posture
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU admission rate
The criteria defined for admission to the ICU included maintenance of SpO2 below 90% with oxygen flow at 15 L / min, RF greater than 30 incursions per minute, reduced level of consciousness, or clinical signs of persistent increase in respiratory work, such as paradoxical ventilatory pattern.
Measured: Patients were followed up for up to 15 days of hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start12 Jul 2020
- Primary completion21 Aug 2020
- Study completion26 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brazilian Institute of Higher Education of Censa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciano Matos Chicayban, Brazilian Institute of Higher Education of Censa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924816
- Sponsor's protocol ID
- ISECENSA
- Status last verified
- Jun 2021
- First submitted
- 10 Jun 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Response to the Awake Prone Position in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04924816
- Acronym / sponsor ID
- ISECENSA
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Brazilian Institute of Higher Education of CensaUniversity, hospital or other
- Study start
- 12 Jul 2020 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 26 Dec 2020 (actual)
- First posted
- 14 Jun 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.
Although prone position is widely used in awake patients with COVID-19 associated with supplemental oxygenation, high flow nasal catheter, or noninvasive ventilation, few studies are attesting to its real benefits on physiological variables or intubation rate. Awake patients dependent on supplemental oxygen may have different responses to PP about peripheral oxygen saturation, heart rate, and respiratory rate. Such responses may be permanent, transient, or even absent. We believe that the response to PP can be a predictor of the need for admission to the ICU. This study aimed to evaluate the acute effects of different types of response to the prone position in patients awake with COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a confirmed diagnosis of COVID-19, spontaneously ventilating, dependent on supplemental oxygen.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- hemodynamic instability, severe obesity, or who were unable to tolerate and cooperate with the performance of PP
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 |
|---|---|---|
| Awake prone positionThe prone position in awake patients consists of asking the patient to voluntarily change to prone position, in a swimmer's posture | Procedure or surgery | – |
Primary outcome
ICU admission rate
Time frame: Patients were followed up for up to 15 days of hospitalization.
The criteria defined for admission to the ICU included maintenance of SpO2 below 90% with oxygen flow at 15 L / min, RF greater than 30 incursions per minute, reduced level of consciousness, or clinical signs of persistent increase in respiratory work, such as paradoxical ventilatory pattern.
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 14 Jun 2021.
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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?
An observational study of Covid19, run by Brazilian Institute of Higher Education of Censa at 1 site in Brazil.
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 0 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 14 Jun 2021. 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 Brazil. 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?
ICU admission rate (time frame: Patients were followed up for up to 15 days of hospitalization.). 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 14 Jun 2021; AzTrials last refreshed its copy on 6 Nov 2026.