University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
Location status: Recruiting
Location contact
Dominik Jarczak, MD
CONTACT
Kevin Roedl, MD
CONTACT
NCT Number: NCT06931938
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
Location status: Recruiting
Dominik Jarczak, MD
CONTACT
Kevin Roedl, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: 28 days
Tracheal intubation and/or all-cause death
Contact information is provided by the study sponsor or research team.
Dominik Jarczak, MD
CONTACT
Kevin Roedl, MD
CONTACT
Universitätsklinikum Hamburg-Eppendorf
Other
Awake PROne Positioning in PatientS With Acute Hypoxemic Respiratory Failure in Germany - A Randomized Controlled Study
Acronym: PROSA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07607080
Acute Hypoxemic Respiratory Failure, Respiration Disorders
Barcelona, Catalonia, Spain
View Trial DetailsNCT06921655
Acute Hypoxemic Respiratory Failure, Mechanical Ventilation Complication
Trento, Italy
View Trial DetailsNCT07175194
Acute Hypoxemic Respiratory Failure, Pathologic Processes
Milan, Italy
View Trial DetailsNCT06501118
Acute Hypoxemic Respiratory Failure, Acute Hypoxic Respiratory Failure
Aurora, Colorado, United States
View Trial Details