Clinical trial NCT03909854: Pragmatic Investigation of Volume Targeted Ventilation-1
Official title: Pragmatic Investigation of Volume Targeted Ventilation-1 (PIVOT-1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Acute Respiratory Distress Syndrome (ARDS)
Ventilator Lung
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Before-and-after trial design of adaptive pressure control and assist volume control
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients receiving Assist Volume Control
timeFrame: 1 hour
Secondary outcomes:
measure: assist volume control duration
timeFrame: 24 hours
measure: Percentage of mode crossover
timeFrame: 2 weeks
measure: exhaled tidal volume
timeFrame: 2 weeks
measure: Number of ventilator free days
timeFrame: 28 days
measure: intensive care length of stay
timeFrame: 28 days
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kevin Gibbs, MD
role: PRINCIPAL_INVESTIGATOR
References:
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