A Study to Assess Cardiopulmonary Measurements in Acute Respiratory Distress Syndrome (ARDS) Patients with Airway Pressure Release Ventilation
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-010051
Sponsor Protocol Number: 18-010051
About this study
The primary purpose of this study is to measure the transpulmonary driving pressures of patients on airway pressure release ventilation (APRV) during a 1 hour period to assess how the lung responds to the mechanical breath profile of APRV with a time-controlled adaptive ventilation (TCAV) protocol.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients aged 18-85 years old.
- Patients receiving mechanical ventilation for ≤ 72hrs.
- Patients who are expected to be intubated for > 24hrs.
- Patients who meet the Berlin Definition criteria for ARDS:
- Acute onset (< 7days) from inciting event;
- PaO2/FiO2 < 250 with a PEEP ≥ 5mmHg;
- Bilateral pulmonary infiltrates on chest x-ray or CT scan;
- Pulmonary infiltrates not fully explained by cardiac failure or fluid overload;
- Already placed arterial line.
Exclusion Criteria:
- Age younger than 18 years or older than 85 years.
- Pregnant.
- Suspected vasculitic pulmonary hemorrhage.
- Obstructive lung disease (this disease process requires a different protocol on APRV than TCAV).
- Neuromuscular disorders that are known to prolong the need for mechanical ventilation.
- Intracranial hypertension.
- Acute coronary syndrome.
- Pneumothorax, subcutaneous emphysema; pneumomediastinum or pneumatocele.
- Bronchopleural fistula.
- Patients in a moribund state or palliative care only.
- Primary provider will not agree to 3 ABGs or a CXR for the study.
- Inability to tolerate additional sedation/hemodynamically unstable.
- Quadriplegia.
- Tracheostomy and/oir ventilator dependent.
- History of lung transplant.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Benjamin Daxon, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available