Acute Hypoxemic Respiratory Failure
Conditions
Brief summary
Prone positioning has shown beneficial effects in intubated patients with severe respiratory failure and positive effects in awake patients with COVID-19 pneumonia. Conclusive evidence for patients with AHRF without COVID-19 is still missing. The investigators hypothesis that awake prone position in patients with AHRF is superior to standard supine/semi-recumbent position in terms of reducing the rate of tracheal intubation and/or all-cause death within 28 days after randomization.
Detailed description
Prone positioning has shown beneficial effects in intubated patients with severe respiratory failure and positive effects in awake patients with COVID-19 pneumonia. Since the pandemic the rate of awake prone positioning has increased and became a standard medical therapy in ICUs worldwide. Conclusive evidence for patients with AHRF without COVID-19 is still missing. The investigators hypothesize that awake prone position in patients with AHRF is superior to standard supine/semi-recumbent position in terms of reducing the rate of tracheal intubation and/or all-cause death within 28 days after randomization. Furthermore, the investigators aim to assess safety and tolerability of awake prone positioning in patients with acute hypoxic respiratory failure due to pneumonia on the ICU.
Interventions
The clinical intervention in the Intervention Group is Awake Prone Positioning, a standard therapy in intensive care units worldwide in ARDS care. The intervention should not be started later than 24 hours after randomization. An earlier start, as soon as possible, after randomization is strongly recommended. In patients in the intervention group standard Awake Prone Positioning for at least 10 hours/day for a length of 72 hours should be applied. The reach the targeted 10 hours / day (per 24 hours), it is strongly recommended to use blocks of a longer time period (e.g. multiple 3-5 hours blocks) within the 24h period to reach the anticipated APP goal. It is recommended that the APP therapy within the targeted intervention for 10 hours/day (per 24 h period) is not interrupted for more than 2 hours till reaching the goal of 10 hours / day (per 24 h). It is further strongly recommended that one APP session should last at least 3 hours. (...) For more information please see the protol.
Sponsors
Charite University, Berlin, Germany
Asklepios Klinikum Harburg
University Hospital Tuebingen
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The focus of this trial is to treat patients with respiratory failure. The inclusion criteria are selected accordingly. Patients meeting all of the criteria listed below will be included in the study: * Patients in the intensive care unit * High possibility of Pneumonia (community-acquired pneumonia or hospital-acquired pneumo-nia) either diagnosed by chest x-ray or computed tomography or clinically diagnosed at least with one of the following signs * Appearance of purulent secretions or changes in characteristics (color, odor, quantity, consistency) * Cough or dyspnea or tachypnea * Evocative auscultation * Presence of acute hypoxemic respiratory failure (PaO2/FIO2 ≤ 300 mmHg or SpO2/FiO2 ≤ 315)
Exclusion criteria
* Patients are excluded from the study if any of the following criteria are met at screening or before ran-domization, a detailed list is shown in the study manual: * Age below 18 * Pregnant woman * Patient is unlikely/unable to awake prone positioning, or to be compliant as indicated by the treating team * Prolonged need (≥ 4 days) for HFNO, NIV or CPAP before study inclusion * Urgent need for endotracheal intubation * Invasive Mechanical Ventilation * Shock o Defined as need for vasopressor ≥ 0.4 mcg/kg/min to maintain a mean blood pressure of ≥ 65 mmHg or systolic blood pressure ≥ 90 mmHg * Participation in another clinical interventional trial in the last 3 months * Previous Participation in the PROSA Trial * Long-term oxygenation therapy (LTOT) or continuous positive airway pressure (CPAP) therapy before hospital admission * Treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tracheal intubation and/or all-cause death | 28 days | Tracheal intubation and/or all-cause death |
Countries
Germany
Contacts
Primary ContactKevin Roedl, MD
Backup ContactDominik Jarczak, MD
Outcome results
None listed