Acute Respiratory Distress Syndrome (ARDS), Respiratory Failure, Ventilator Lung
Conditions
Brief summary
This proposal will test the feasibility of implementing an assist volume control ventilation protocol in patients receiving mechanical ventilation in the medical intensive care unit. The trial will consist of a before-and-after trial design of block assignment to either adaptive pressure control (baseline) or assist volume control . This is a feasibility study looking at the management of patients in the ventilator.
Detailed description
Over the course of 6 weeks, a before-and-after trial design of adaptive pressure control and assist volume control will be conducted. Pre-trial planning phase: study protocols will be reviewed with key stakeholders (respiratory therapy providers and medical teams) Weeks 1-2: data will be collected on our current adaptive pressure control ventilator protocol. Week 3: The investigators will implement an assist volume control protocol. . Patients already on mechanical ventilation will be converted to assist volume control; however, these patients will not be included in the primary analysis.In accordance with the Consolidated Framework For Implementation Research (CFIR) approach, after 1 week of assist volume control the investigators will engage in quantitative and qualitative feedback with care providers to identify facilitators and barriers of assist volume control implementation. Week 4-6: If the investigators identify substantial barriers, the investigators will pause and alter the protocol. If not, the investigators will continue assist volume control for an additional 2 weeks.
Interventions
PROCEDUREmode of mechanical ventilation
Adaptive Pressure Control mechanical ventilation is a dual controlled mode that is designed to auto-control flow and minimize inspiratory pressure while delivering a provider-determined tidal volume. Assist Volume Control mechanical ventilation is a mode in which the respiratory care provider determines patient tidal volume and flow.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Before-and-after trial design of adaptive pressure control and assist volume control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Acute Respiratory Failure requiring mechanical ventilation medical intensive care unit admission
Exclusion criteria
chronic mechanical ventilation clinician use of non-volume-targeted ventilation as initial mode
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients receiving Assist Volume Control | 1 hour | The primary outcome for the PIVOT-1 pilot is feasibility of Assist Volume Control implementation. We define feasibility in this study as 80% of patients receiving Assist Volume Control within 1 hour of initiation of intensive care unit mechanical ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assist volume control duration | 24 hours | A secondary feasibility outcome will be \>70% of ventilated time on Assist Volume Control during the first 24 hours of mechanical ventilation. |
| Percentage of mode crossover | 2 weeks | A secondary feasibility outcome will include \<10% crossover to the alternative mode |
| exhaled tidal volume | 2 weeks | exhaled tidal volume will be compared between modes using data extracted from the critical care data capsule. |
| Number of ventilator free days | 28 days | vent free days will be compared between the modes using data from the critical care data analytics platform |
| intensive care length of stay | 28 days | intensive care unit length of stay will be compared between the modes using data from the critical care data analytics platform |
Countries
United States
Outcome results
None listed