Covid19DeCOPONCT04543760
Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to COVID-19
A study testing Prone position and Supine position in people with Covid19, run by Hospital St. Joseph, Marseille, France at 4 sites in France.
Trial summary
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Prone position and Supine position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Oct 2020to 14 Mar 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years,
- Admitted to ICU within 72 hours,
- Having confirmed or highly suspected COVID-19 infection (positive RT-PCR and/or computed tomography),
- Having acute hypoxemic respiratory failure with a [PaO2/FiO2] ratio between 100 mmHg and 300 mmHg,
- Having given free and informed written consent,
- Being affiliated with or benefiting from a social security scheme.
Who cannot join
- Unable to achieve a prone position for mobility reasons,
- Unable to achieve a prone position due to agitation whatever the cause,
- With clinical occlusive syndrome in order to limit the risk of inhalation,
- Having a contraindication to the use of the esophageal catheter,
- Having signs of respiratory distress or disturbance of consciousness requiring intubation within the next hours,
- Having hypercapnia indicating the use of non-invasive ventilation (PaO2> 50 mmHg),
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- Having severe hypoxemia defined by PaO2 / FiO2 <100mmHg,
- Ongoing pregnancy or breastfeeding,
- Subject to a measure for the protection of justice.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hopital Européen
Marseille, 13003
Hopital La Timone
Marseille, 13005
Hopital Saint Joseph
Marseille, 13008
Hopital Nord
Marseille, 13915
About this study
Official title: Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to Sars-covid-2: a Randomized Crossover Trial.
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality.
Prone positioning (PP) is a recommended strategy for patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation.
Early PP combined with High Flow Oxygen Therapy may benefit spontaneous breathing patients with AHRF due to COVID-19 as recently reported in Jiangsu.
Our hypothesis is that early PP combined with High Flow Oxygen Therapy in patients with AHRF due to COVID-19 improves oxygenation.
- Conditions
- Covid19
- Being tested
- Prone position, Supine 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.
Prone positionOther
prone positioning in spontaneous ventilation
Supine positionOther
supine positiong in spontaneous ventilation
| Study group | Role | What they receive |
|---|---|---|
| [PP sequence 1] - Wash-out - [SP sequence 2] | Other | Not described Receives: Other: Prone position; Other: Supine position |
| [SP sequence 1] - Wash-out - [PP sequence 2] | Other | Not described Receives: Other: Prone position; Other: Supine position |
What is being measured
The primary outcome is the main question the study is designed to answer.
[PaO2 / FiO2] ratio
Oxygenation will be evaluated by the [PaO2 / FiO2] ratio, measured at the beginning (baseline) and at the end of each 2h-sequence by arterial gasometry. The values of this ratio in PP and SP will be compared with each other.
Measured: 6 hours
Secondary outcomes (6)
ΔPeso measured using an esophageal balloon catheter
ΔPeso (cm H2O): defined at each inspiratory cycle as the difference between the esophageal pressure at the end of expiration and at the end of inspiration.
Measured: 6 hours
Concentration of CO2 at the end of expiration (EtCO2, mmHg)
Capnometry measurements by breathing on a mouthpiece connected to an online analyzer.
The measurements will be made on a 2 min recording (analysis of the curves over a period of 1 min) at the end of each sequence (PP or SP) and compared with each other.
Measured: 6 hours
Intensity of dyspnea
assessed by the visual analogue scale for dyspnea (collected at the beginning and at the end of each 2h sequence; the values at the end of each sequence will be compared with each other): 0 = no breathlessness to 10 = worst breathlessness possible
Measured: 6 hours
Tolerance of the technique
measured by the visual analogue scale for pain (collected at the beginning and at the end of each 2h-sequence; the values at the end of each sequence will be compared with each other): 0 = no pain to 10 = worst pain possible
Measured: 6 hours
Tolerance of the technique
measured by the visual analogue scale for discomfort (collected at the beginning and at the end of each 2h-sequence; the values at the end of each sequence will be compared with each other): 0 = no discomfort to 10 = worst discomfort possible
Measured: 6 hours
The occurrence of side effects due to PP
Oxygen desaturation (SaO2 <90%), occurrence of hemodynamic instability (Systolic blood pressure <80 mmHg or heart rate >120 mmHg for >1 minute), accidental withdrawal of venous catheter central or peripheral, accidental withdrawal of arterial catheter, accidental withdrawal of urinary catheter.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Oct 2020
- Primary completion15 Jan 2021
- Study completion14 Mar 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel LEHINGUE, M.D, Principal investigator, Hopital Saint Joseph Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543760
- Sponsor's protocol ID
- 2020-04-03
- Acronym
- DeCOPO
- Status last verified
- Mar 2022
- First submitted
- 8 Sep 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to Sars-covid-2: a Randomized Crossover Trial.
- ClinicalTrials.gov ID
- NCT04543760
- Acronym / sponsor ID
- DeCOPO / 2020-04-03
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 14 Mar 2021 (actual)
- First posted
- 10 Sep 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 main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality.
Prone positioning (PP) is a recommended strategy for patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation.
Early PP combined with High Flow Oxygen Therapy may benefit spontaneous breathing patients with AHRF due to COVID-19 as recently reported in Jiangsu.
Our hypothesis is that early PP combined with High Flow Oxygen Therapy in patients with AHRF due to COVID-19 improves oxygenation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [PP sequence 1] - Wash-out - [SP sequence 2] | Other | Other: Prone position, Other: Supine position |
| [SP sequence 1] - Wash-out - [PP sequence 2] | Other | Other: Prone position, Other: Supine position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 years,
- Admitted to ICU within 72 hours,
- Having confirmed or highly suspected COVID-19 infection (positive RT-PCR and/or computed tomography),
- Having acute hypoxemic respiratory failure with a [PaO2/FiO2] ratio between 100 mmHg and 300 mmHg,
- Having given free and informed written consent,
Key exclusion criteria (9 listed)
- Unable to achieve a prone position for mobility reasons,
- Unable to achieve a prone position due to agitation whatever the cause,
- With clinical occlusive syndrome in order to limit the risk of inhalation,
- Having a contraindication to the use of the esophageal catheter,
- Having signs of respiratory distress or disturbance of consciousness requiring intubation within the next hours,
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 positioning in spontaneous ventilation | Other | [PP sequence 1] - Wash-out - [SP sequence 2], [SP sequence 1] - Wash-out - [PP sequence 2] |
| Supine positionsupine positiong in spontaneous ventilation | Other | [PP sequence 1] - Wash-out - [SP sequence 2], [SP sequence 1] - Wash-out - [PP sequence 2] |
Primary outcome
[PaO2 / FiO2] ratio
Time frame: 6 hours
Oxygenation will be evaluated by the [PaO2 / FiO2] ratio, measured at the beginning (baseline) and at the end of each 2h-sequence by arterial gasometry. The values of this ratio in PP and SP will be compared with each other.
6 secondary outcomes
ΔPeso measured using an esophageal balloon catheter
Time frame: 6 hours
Concentration of CO2 at the end of expiration (EtCO2, mmHg)
Time frame: 6 hours
Intensity of dyspnea
Time frame: 6 hours
Tolerance of the technique
Time frame: 6 hours
Tolerance of the technique
Time frame: 6 hours
The occurrence of side effects due to PP
Time frame: 6 hours
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 22 Mar 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures, and appendices).
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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.
Samuel LEHINGUE, M.D principal investigator
Hopital Saint Joseph Marseille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone position and Supine position in people with Covid19, run by Hospital St. Joseph, Marseille, France at 4 sites in France.
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 6 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 22 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 4 sites in France. 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?
[PaO2 / FiO2] ratio (time frame: 6 hours). 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 22 Mar 2022.