Pragmatic Investigation of Volume Targeted Ventilation-1

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pragmatic Investigation of Volume Targeted Ventilation-1 (PIVOT-1)

Conditions
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Respiratory Failure, Ventilator Lung, Acute Respiratory Distress Syndrome (ARDS)

Intervention / Treatment
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* Procedure: mode of mechanical ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Before-and-after trial design of adaptive pressure control and assist volume control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adaptive Pressure Control<br>The Adaptive Pressure Control arm is the baseline mode/protocol for medical intensive care unit mechanical ventilation | Procedure: mode of mechanical ventilation<br>* 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.<br>|
| Active Comparator: Assist Volume Control<br>The assist volume control arm is the new protocol that will be implemented and tested for feasibility | Procedure: mode of mechanical ventilation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients receiving Assist Volume Control | 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 | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assist volume control duration | A secondary feasibility outcome will be >70% of ventilated time on Assist Volume Control during the first 24 hours of mechanical ventilation. | 24 hours | 
| Percentage of mode crossover | A secondary feasibility outcome will include <10% crossover to the alternative mode | 2 weeks | 
| exhaled tidal volume | exhaled tidal volume will be compared between modes using data extracted from the critical care data capsule. | 2 weeks | 
| Number of ventilator free days | vent free days will be compared between the modes using data from the critical care data analytics platform | 28 days | 
| intensive care length of stay | intensive care unit length of stay will be compared between the modes using data from the critical care data analytics platform | 28 days |