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

Wake Forest University (WFU)

Status: Completed

Conditions: Respiratory Failure; Ventilator Lung; Acute Respiratory Distress Syndrome (ARDS)

Treatments: Procedure: mode of mechanical ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03909854

IRB00055128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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139 participants in 2 patient groups

Adaptive Pressure Control

Active Comparator group

Description:

The Adaptive Pressure Control arm is the baseline mode/protocol for medical intensive care unit mechanical ventilation

Treatment:

Procedure: mode of mechanical ventilation

Assist Volume Control

Active Comparator group

Description:

The assist volume control arm is the new protocol that will be implemented and tested for feasibility

Treatment:

Procedure: mode of mechanical ventilation