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Clinical Trials/NCT03909854
NCT03909854
Completed
Not Applicable

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

Wake Forest University Health Sciences1 site in 1 country139 target enrollmentSeptember 9, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Wake Forest University Health Sciences
Enrollment
139
Locations
1
Primary Endpoint
Percentage of patients receiving Assist Volume Control
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 9, 2019
End Date
February 20, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Percentage of patients receiving Assist Volume Control

Time Frame: 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 Outcomes

  • exhaled tidal volume(2 weeks)
  • intensive care length of stay(28 days)
  • assist volume control duration(24 hours)
  • Number of ventilator free days(28 days)
  • Percentage of mode crossover(2 weeks)

Study Sites (1)

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