Covid19NCT04641182
Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure
An observational study of Covid19 and Ards, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The aim of this observational study is to evaluate the physiological and clinical effects of prone position in awake patients with respiratory failure due to COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Ards, Respiratory Failure
- What is being tested?
- Prone position
- How many people
- 66 participants
- Where
- 1 siteChile
- Study dates
- 6 Jul 2020to 16 Sep 2020
- How long will I take part?
- 28 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized COVID-19 adult patients with acute respiratory failure
Who may be able to join
- Hospitalized patients with confirmed or suspected COVID-19 pneumonia requiring more than 3 liters per minute of supplemental oxygen or a Fraction of Inspired Oxygen (FIO2) over 35% to keep Pulse Oximetry Saturation (SpO2) over 90%
- Treating physician indicated prone position as instructed by the institutional protocol
- Patient capable of changing position with minimal help from the personnel
Who cannot join
- Patient requiring immediate intubation
- Patient requiring non-invasive mechanical ventilation
- Respiratory Rate > 40, signs of respiratory fatigue or unconsciousness with inability to protect the airway
- PaCO2 > 50mmHg
- Hemodynamic instability (defined by Heart Rate > 120, Systolic Pressure < 90mmHg, Mean Arterial Pressure < 60mmHg or requiring vasopressor support)
- Obesity with BMI > 40 (Body Mass Index: weight in kilograms and height in meters will be combined to attain BMI in kg/m2)
Show all 9Show fewer
- Persistent vomiting
- Facial or thoracic trauma or recent surgery contraindicating the prone position
- Pregnancy > 20 weeks
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clinico Red de Salud UC - Christus
Santiago, Santiago Metropolitan
About this study
Official title: Observational Study of Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure
The aim of this observational study is to evaluate the physiological and clinical effects of prone position in awake patients with respiratory failure due to COVID-19.
Read the detailed description
The purpose of this study is to investigate the role of prone positioning in SARS-CoV-2 infected patients that are not intubated. Prone patient placement during invasive mechanical ventilation is a widespread practice in the management of severe ARDS. However, few attempts have been made to implement the prone position in patients that spontaneously ventilate with supplemental oxygen. Considering that it is a procedure that does not require additional equipment and does not represent an additional cost for its implementation, it becomes a valuable tool in the context of COVID-19 where intubation is associated with high mortality. The investigators will analyze a cohort of patients with COVID-19 and respiratory failure managed with prone position as indicated by the attending physician and register physiological variables and clinical outcomes (intubation and death).
- Conditions
- Covid19, Ards, Respiratory Failure
- Being tested
- Prone position
- Medical subject headings
- COVID-19, Acute Lung Injury, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positionOther
Prone position as indicated by the treating physician as specified in the institutional protocol
| Study group | Role | What they receive |
|---|---|---|
| Prone position | Prone position per institutional protocol and as indicated by the treating physician Receives: Other: Prone position | |
| No prone position | The control group will not be in prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic failure
Defined by death or intubation or use of non-invasive ventilation
Measured: At 14 days
Mortality
Number of patients that die
Measured: At day 28
Length of hospital stay
Number of days spent by the patients at the hospital
Measured: At 28 days
Days requiring high flow nasal oxygen
Number of days the patients require high flow nasal oxygen therapy
Measured: At 28 days
Days requiring supplemental oxygen
Number of days the patients require supplementary oxygen
Measured: At 28 days
Displacement of invasive devices during position changes
Unintentional displacement or removal of Invasive devices including : central and peripheric vascular catheters, urinary catheter and chest tubes
Measured: At 28 days
Occurrence of pressure ulcers on the anterior surface of the body
Number of patients that develope pressure ulcers on the anterior surface of the body
Measured: At 28 days
Secondary outcomes (4)
Respiratory superinfection
Certified by a respiratory tract sample and culture
Measured: At 28 days
Delirium
Defined by the Confusion Assessment Method (CAM)
Measured: At 28 days
Caloric intake
Daily number of ingested calories (in kilocalories) by the patients is recorded
Measured: At 28 days
Proteic intake
Daily number of ingested proteins (in grams) by the patients is recorded
Measured: At 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start6 Jul 2020
- Primary completion16 Aug 2020
- Study completion16 Sep 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.
- More trials run by Pontificia Universidad Catolica de ChileThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641182
- Sponsor's protocol ID
- 0001
- Status last verified
- Nov 2020
- First submitted
- 12 Sep 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT04641182
- Acronym / sponsor ID
- 0001
- Conditions
- Covid19, Ards, Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 16 Aug 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 23 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 aim of this observational study is to evaluate the physiological and clinical effects of prone position in awake patients with respiratory failure due to COVID-19.
Detailed description
The purpose of this study is to investigate the role of prone positioning in SARS-CoV-2 infected patients that are not intubated. Prone patient placement during invasive mechanical ventilation is a widespread practice in the management of severe ARDS. However, few attempts have been made to implement the prone position in patients that spontaneously ventilate with supplemental oxygen. Considering that it is a procedure that does not require additional equipment and does not represent an additional cost for its implementation, it becomes a valuable tool in the context of COVID-19 where intubation is associated with high mortality. The investigators will analyze a cohort of patients with COVID-19 and respiratory failure managed with prone position as indicated by the attending physician and register physiological variables and clinical outcomes (intubation and death).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone position | – | Other: Prone positionProne position per institutional protocol and as indicated by the treating physician |
| No prone position | – | –The control group will not be in prone position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized COVID-19 adult patients with acute respiratory failure
Key inclusion criteria (3 listed)
- Hospitalized patients with confirmed or suspected COVID-19 pneumonia requiring more than 3 liters per minute of supplemental oxygen or a Fraction of Inspired Oxygen (FIO2) over 35% to keep Pulse Oximetry Saturation (SpO2) over 90%
- Treating physician indicated prone position as instructed by the institutional protocol
- Patient capable of changing position with minimal help from the personnel
Key exclusion criteria (9 listed)
- Patient requiring immediate intubation
- Patient requiring non-invasive mechanical ventilation
- Respiratory Rate > 40, signs of respiratory fatigue or unconsciousness with inability to protect the airway
- PaCO2 > 50mmHg
- Hemodynamic instability (defined by Heart Rate > 120, Systolic Pressure < 90mmHg, Mean Arterial Pressure < 60mmHg or requiring vasopressor support)
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 |
|---|---|---|
| Prone positionProne position as indicated by the treating physician as specified in the institutional protocol | Other | Prone position |
Primary outcome
Therapeutic failure
Time frame: At 14 days
Defined by death or intubation or use of non-invasive ventilation
Mortality
Time frame: At day 28
Number of patients that die
Length of hospital stay
Time frame: At 28 days
Number of days spent by the patients at the hospital
Days requiring high flow nasal oxygen
Time frame: At 28 days
Number of days the patients require high flow nasal oxygen therapy
Days requiring supplemental oxygen
Time frame: At 28 days
Number of days the patients require supplementary oxygen
Displacement of invasive devices during position changes
Time frame: At 28 days
Unintentional displacement or removal of Invasive devices including : central and peripheric vascular catheters, urinary catheter and chest tubes
Occurrence of pressure ulcers on the anterior surface of the body
Time frame: At 28 days
Number of patients that develope pressure ulcers on the anterior surface of the body
4 secondary outcomes
Respiratory superinfection
Time frame: At 28 days
Delirium
Time frame: At 28 days
Caloric intake
Time frame: At 28 days
Proteic intake
Time frame: At 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 23 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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 and Ards, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 3 inclusion and 9 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 23 Nov 2020. 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 Chile. 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?
Therapeutic failure (time frame: At 14 days). The study lists 7 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 23 Nov 2020.