Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy

Official title

Awake Prone Positioning of Patients Suffering Community Acquired Pneumonia Requiring Nasal High Flow Therapy, Excluding COVID-19

Overview

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.

Interventions

• Other Prone position
  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).

Primary outcome measures

• Intubation within 28 days of randomization [Time frame: From randomization to day 28]

Secondary outcome measures (12)

• Patient comfort before the first prone session, using a visual analogue scale. [Time frame: From randomization to 6 hours]
• Patient comfort during the first prone session, using a visual analogue scale. [Time frame: From randomization to day 1]
• Patient comfort after the first prone session, using a visual analogue scale. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: From randomization to day 1]
• Daily patient comfort comparison between groups from day 1 to day 3, using a visual analogue scale. [Time frame: From day 1 to day 3]
• Oxygenation (PaO2/FiO2 ratio and ROX index) daily comparison between groups from day 1 to day 3. [Time frame: 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). [Time frame: 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). [Time frame: 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). [Time frame: From randomization to day 28]
• Mortality [Time frame: From randomization to day 90]

Eligibility criteria

Inclusion criteria

• Adult patients admitted to an intensive care unit or intermediate care unit
• Suspicion of community acquired pneumonia (at least one of the 3 criteria): fever, cough, purulent expectoration
• And abnormalities suggestive of pneumonia by chest X-ray or CT-scan
• PaO2/FiO2 ratio <300 mmHg (or equivalent SpO2/FiO2 i.e. < 315 mmHg) under a minimum gas flow of 30 L/min.
• Person affiliated to a French social security system or equivalent
• Informed consent.

Exclusion criteria

• Positive SARS-COV2 test within the last 30 days
• Indication for immediate intubation
• Patients for whom a "do not intubate" decision has been made
• Chest trauma or other contraindication to prone position
• Patients with formal indication for non-invasive ventilation: exacerbation of chronic obstructive pulmonary disease, acute cardiogenic pulmonary oedema.
• Pregnant or breastfeeding woman
• Subjects who are under legal protection measure
• More than 8h awake prone positioning prior to inclusion
• More than 48h since intensive care unit or intermediate care unit admission.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 38 centers

• Intensive care, University Hospital, Amiens — Amiens
• Intensive care, University Hospital, Angers — Angers
• Intensive care, University Hospital, Argenteuil — Argenteuil
• Intensive care, University Hospital, Belfort — Belfort
• Intensive care, University Hospital, Besancon — Besançon
• Intensive care, University Hospital, Bethune — Béthune
• Intensive care, University Hospital, Blois — Blois
• Intensive care, University Hospital, Bordeaux — Bordeaux
• … and 30 more centers

Identifiers

NCT: NCT06966310 · DR230003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗