NCT03909854

Pragmatic Investigation of Volume Targeted Ventilation-1

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Failure
• Acute Respiratory Distress Syndrome (ARDS)
• Ventilator Lung

Interventions

Type	Name	Description
PROCEDURE	mode 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.

Timeline

• Start date: 2019-09-09
• Primary completion: 2019-11-12
• Completion: 2020-02-20
• First posted: 2019-04-10
• Last updated: 2023-07-07

Locations

1 site across 1 country: United States