Status:
UNKNOWN
Prone Positioning and Spontaneous Breathing
Lead Sponsor:
Osaka University
Collaborating Sponsors:
Hospital Rebagliati
Conditions:
Critical Illness
ARDS
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Spontaneous breathing during mechanical ventilation has been recommended in patients with ARDS and is currently used. in part because oxygenation is better and there is a lower risk of diaphragm dysfu...
Detailed Description
The multi-center feasibility study will enroll 12 adult ARDS patients from the Intensive Care Units (ICUs) in Japan and Peru. Informed consent will be obtained from the patient or legally authorized s...
Eligibility Criteria
Inclusion
- Patients ≧ 18 years old
- Patients with moderate-to-severe ARDS as per the Berlin definition
- Patients with esophageal balloon manometry
- Patients planned to turn to prone positioning, based on the attending physician's decisions
Exclusion
- Contraindication for prone positioning, referring to a previous randomized clinical trial
- Intracranial pressure \>30 mm Hg or cerebral perfusion pressure \<60 mmHg
- Massive hemoptysis requiring an immediate surgical or interventional radiology procedure
- Tracheal surgery or sternotomy during the previous 15 days
- Serious facial trauma or facial surgery during the previous 15 days
- Cardiac pacemaker inserted in the last 2 days
- Unstable spine, femur, or pelvic fractures
- Major hemodynamic instability:
- Mean arterial pressure lower than 60 mm Hg despite adequate fluid resuscitation and two vasopressors or increase of vasopressor dose by 30% in the previous 6 hours.
- Contraindication to EIT electrode placement Burns, chest wall bandaging limiting electrode placement, pacemaker
- Clinical judgement of the attending physician against proning and/or spontaneous breathing
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03768154
Start Date
March 1 2019
End Date
March 31 2021
Last Update
May 15 2020
Active Locations (1)
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1
Osaka University Hospital
Suita, Osaka, Japan, 565-0871