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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [PP sequence 1] - Wash-out - [SP sequence 2] | Other |
| |
| [SP sequence 1] - Wash-out - [PP sequence 2] | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prone position | Other | prone positioning in spontaneous ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| [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. | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 hours |
| Concentration of CO2 at the end of expiration (EtCO2, mmHg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel LEHINGUE, M.D | Hopital Saint Joseph Marseille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Européen | Marseille | 13003 | France | |||
| Hopital La Timone |
Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures, and appendices).
beginning 3 months and ending 2 years following article publication
The data will be shared with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
The proposal should be directed to the PI, Dr Lehingue.
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| Supine position | Other | supine positiong in spontaneous ventilation |
|
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. |
| 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 | 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 | 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 | 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. | 6 hours |
| Marseille |
| 13005 |
| France |
| Hopital Saint Joseph | Marseille | 13008 | France |
| Hopital Nord | Marseille | 13915 | France |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016684 | Prone Position |
| D016683 | Supine Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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