Status:
WITHDRAWN
Repeated Measures Trial of Temporary Automated Manual Ventilation Versus Noninvasive Oxygenation or Conventional Vent
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Respiratory Failure
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The COVID-19 pandemic has led to a potential shortage of life-saving mechanical ventilators. The purpose of this study is to determine whether a novel simpler to device, the automated bag-valve-mask (...
Detailed Description
This study will be performed in the emergency department and ICU's of Massachusetts General Hospital (MGH). Thirty patients requiring mechanical ventilation will be enrolled. The design is a case seri...
Eligibility Criteria
Inclusion
- Patient may be diagnosed with Covid-19 based on clinical presentation and available laboratory studies including specific Covid-19 testing.
- Patient with imminent respiratory failure or status post respiratory failure receiving mechanical ventilation, or requiring mechanical ventilation for airway protection or other cause.
- Evidence of no pulmonary disease, or mild to moderate ARDS based on:
- fraction of inspired oxygen (FiO2) ≤ 60% with arterial oxygen saturation \> 90%
- positive end expiratory pressure (PEEP) ≤ 12 cm H20
- Using an adaptive trial design, the first 10 patients must require mechanical ventilation for reasons other than COVID-19 infection such as airway protection due to overdose, seizure, stroke, or trauma. The next 10 patients may have COVID-19 infection, but must demonstrate lung compliance ≥ 40 ml/cm H2O. If these 10 patients demonstrate a satisfactory course associated with treatment, then the final 10 patients may have lung compliance ≥ 30 ml/cm H2O. Satisfactory treatment course will include, at a minimum: oxygen saturation \> 90%, with PEEP ≤ 12 cm H2O.
Exclusion
- Lack of informed consent from patient, if deemed having capacity, or from surrogate if not
- Too medically unstable to participate in study per treating clinician
- Patients requiring more than one vasopressor medication for blood pressure support
- Age \> 65 years
- Clinical evidence of acute coronary syndrome (ACS) including angina, or ECG evidence of acute ischemia or dysrhythmia
- Chronic lung disease including chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, or pulmonary hypertension
- Gross laboratory abnormalities including, when available: liver function tests (LFT) \> 5x normal, C-reactive protein (CRP) \> 200 mg/L, ferritin \> 2000 µg/L, creatine phosphokinase (CPK) \> 3x normal, D-Dimer \> 2500 ng/ml
- Previously enrolled subject
- Children
- Pregnant women
- Estimated body mass index (BMI) greater than 30
- Prisoners
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04369274
Start Date
August 1 2022
End Date
November 1 2023
Last Update
March 15 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.