Awake PROne Positioning in PatientS With Acute Hypoxemic Respiratory Failure in Germany - A Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Germany
University Medical Center Hamburg-Eppendorf
RECRUITING
Hamburg
Contact Information
Primary
Kevin Roedl, MD
k.roedl@uke.de
+49 40 7410 35315
Backup
Dominik Jarczak, MD
d.jarczak@uke.de
+49 40 7410 35315
Time Frame
Start Date: 2025-04-11
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 342
Treatments
Active_comparator: Awake prone positioning
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 24h). It is further strongly recommended that one APP session should last at least 3 hours. (...) For more information please see the protocol.
No_intervention: Standard supine/semi-recumbent positioning
Patients randomized to the control arm will receive standard positioning at the discretion of the treating team but excluding APP. Control group patients will remain in their natural choice of position, which is anticipated to favour a supine, semi-recumbent position. The use of awake prone positioning as a so-called rescue intervention is discouraged in the control group and recorded as a protocol violation.~If patients have to be tracheal intubated and mechanically ventilated treatment should follow current ARDS guidelines. This includes PP in patients with mild to severe ARDS if PaO2/FiO2 is below 150 mmHg.
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital Tuebingen, Charite University, Berlin, Germany, Asklepios Klinikum Harburg
Leads: Universitätsklinikum Hamburg-Eppendorf

This content was sourced from clinicaltrials.gov