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Community acquired pneumonia, in particular when requiring oxygen therapy because of acute hypoxemic respiratory failure and meeting acute respiratory distress syndrome (ARDS) criteria frequently leads to tracheal intubation and poor outcome.
Among invasively mechanically ventilated patients with ARDS and presenting a PaO2/FiO2 ratio (arterial partial pressure of oxygen to inspired fraction of oxygen) of less than 150 mmHg, the prone position significantly reduces mortality and represents standard care (Guérin 2013). Among non-intubated COVID-19 patients, a subtype of viral community acquired pneumonia, a recent study showed that awake prone positioning reduces the composite outcome of intubation or death among patients requiring nasal high flow therapy. Furthermore, it favored weaning of nasal high flow therapy.
Prone position in patients with non-COVID ARDS treated with high nasal flow was evaluated in 20 patients with predominantly viral pneumonia (Ding 2020) and was associated with improved oxygenation.
Coordinating investigator hypothesize that prone positioning of patients suffering non-COVID community acquired pneumonia and undergoing nasal high flow therapy can significantly improve outcome by reducing the need for intubation and associated therapies such as sedation and muscle relaxation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prone position group | Experimental | patients will be invited and assisted to prone as long as possible every day. The goal is to achieve at least 8h in the prone position per 24h period, with 3-6 prone sessions. |
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| Control group | No Intervention | Usual care including nasal high flow therapy adapted for a SpO2 of 92-95%. No prone positioning. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prone position | Other | depending on tolerance, the objective is to spend as much time as possible, up to 16h and beyond, in prone position per period of 24 hours. For each session the patients will be encouraged to stay as long as possible in the prone position (i.e. ideally 4-8 hours each session). |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation within 28 days of randomization | Analyzed in a competing risk framework with death and intensive care unit discharge taken into account as competing events. | From randomization to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient comfort before the first prone session, using a visual analogue scale. | A scale from 0 to 10, where 0 means total discomfort and 10 means optimal comfort. | From randomization to 6 hours |
| Patient comfort during the first prone session, using a visual analogue scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephan EHRMANN | Contact | 2.47.47.38.55 | +33 | stephanehrmann@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Stephan EHRMANN | University Hospital, Tours | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive care, University Hospital, Amiens | Not yet recruiting | Amiens | France |
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|
A scale from 0 to 10, where 0 means total discomfort and 10 means optimal comfort. |
| From randomization to day 1 |
| Patient comfort after the first prone session, using a visual analogue scale. | A scale from 0 to 10, where 0 means total discomfort and 10 means optimal comfort. | From randomization to day 1 |
| Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) before the first prone session for patients in the intervention group. | From randomization to 6 hours |
| Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) during the first prone session for patients in the intervention group. | From randomization to day 1 |
| Oxygenation (PaO2/FiO2 ratio and ROX index [ratio of SpO2/FiO2 to respiratory rate, Roca 2019]) after the first prone session for patients in the intervention group. | From randomization to day 1 |
| Daily patient comfort comparison between groups from day 1 to day 3, using a visual analogue scale. | From day 1 to day 3 |
| Oxygenation (PaO2/FiO2 ratio and ROX index) daily comparison between groups from day 1 to day 3. | From day 1 to day 3 |
| Time to treatment escalation to non-invasive ventilation or continuous positive airway pressure (CPAP) with intubation or death as competing events (up to day 28 or intensive care unit discharge whichever occurs first). | From randomization to day 28 or intensive care unit discharge whichever occurs first |
| Time to successful weaning of nasal high flow with intubation or death as competing events (up to day 28 or intensive care unit discharge whichever occurs first). | From randomization to day 28 or intensive care unit discharge whichever occurs first |
| Time to intensive care unit discharge and time to hospital discharge (up to day 28). | From randomization to day 28 |
| Mortality | From randomization to day 90 |
| Mortality | From randomization to day 28 or intensive care unit and hospital discharge |
| Nursing workload: time spent in the patient room by nursing staff during the 24 hours post randomization in both groups | measured as person.hours | From randomization to 24 hours post randomization |
| Evolution of patient's quality of life | using the EQ-5D-5L questionnaire. The response is given on 5-point scales (1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: extreme problems or total inability) | At 90 days |
| Evolution of patient's quality of life | using the EQ-5D-5L questionnaire. The response is given on 5-point scales (1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: extreme problems or total inability) | At 5 years |
| Safety: skin lesions, lines dislodgement, central line infection, vomiting, (up to day 28 or intensive care unit discharge whichever occurs first). | From randomization to day 28 or intensive care unit discharge whichever occurs first). |
| Intensive care, University Hospital, Angers | Not yet recruiting | Angers | France |
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| Intensive care, University Hospital, Argenteuil | Not yet recruiting | Argenteuil | France |
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| Intensive care, University Hospital, Belfort | Not yet recruiting | Belfort | France |
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| Intensive care, University Hospital, Besancon | Not yet recruiting | Besançon | France |
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| Intensive care, University Hospital, Bethune | Not yet recruiting | Béthune | France |
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| Intensive care, University Hospital, Blois | Not yet recruiting | Blois | France |
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| Intensive care, University Hospital, Bordeaux | Not yet recruiting | Bordeaux | France |
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| Intensive care, University Hospital, Bourg en Bresse | Not yet recruiting | Bourg-en-Bresse | France |
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| Intensive care, University Hospital, Bourges | Recruiting | Bourges | France |
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| Intensive care, University Hospital, Brest | Not yet recruiting | Brest | France |
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| Intensive care, University Hospital, Colombes | Not yet recruiting | Colombes | France |
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| Intensive care, University Hospital, Dieppe | Not yet recruiting | Dieppe | France |
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| Intensive care, University Hospital, Dijon | Recruiting | Dijon | France |
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| Intensive care, University Hospital, Dreux | Not yet recruiting | Dreux | France |
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| Intensive care, University Hospital, Garches | Not yet recruiting | Garche | France |
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| Intensive care, University Hospital, Grenoble | Not yet recruiting | Grenoble | France |
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| Intensive care, University Hospital, La Roche sur Yon | Recruiting | La Roche-sur-Yon | France |
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| Intensive care, University Hospital, Le Mans | Recruiting | Le Mans | France |
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| Intensive care, University Hospital, Lens | Recruiting | Lens | France |
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| Intensive care, University Hospital, Lille | Not yet recruiting | Lille | France |
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| Intensive care, University Hospital, Lorient | Not yet recruiting | Lorient | France |
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| Intensive care, University Hospital, Lyon | Not yet recruiting | Lyon | France |
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| Intensive care, University Hospital, Lyon | Not yet recruiting | Lyon | France |
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| Intensive care, University Hospital, Morlaix | Recruiting | Morlaix | France |
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| Intensive care, University Hospital, Nantes | Recruiting | Nantes | France |
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| Intensive care, University Hospital, Nice | Not yet recruiting | Nice | France |
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| Intensive care, University Hospital, Nice | Not yet recruiting | Nice | France |
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| Intensive care, University Hospital, Orléans | Not yet recruiting | Orléans | France |
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| Intensive care, University Hospital, Cochin | Not yet recruiting | Paris | France |
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| Intensive care, University Hospital, Tenon | Not yet recruiting | Paris | France |
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| Intensive care, University Hospital, Poitiers | Recruiting | Poitiers | France |
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| Intensive care, University Hospital, Rouen | Not yet recruiting | Rouen | France |
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| Intensive care, University Hospital, Saint Brieuc | Recruiting | Saint-Brieuc | France |
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| Intensive care, University Hospital, Saint Nazaire | Recruiting | Saint-Nazaire | France |
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| Intensive care, University Hospital, Strasbourg | Not yet recruiting | Strasbourg | France |
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| Intensive care, University Hospital, Strasbourg | Not yet recruiting | Strasbourg | France |
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| Intensive care, University Hospital, Tours | Recruiting | Tours | France |
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| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016684 | Prone Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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