Pragmatic Investigation of Volume Targeted Ventilation-1 (PIVOT-1)
Primary Purpose
Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS), Ventilator Lung
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mode of mechanical ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure
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
Sites / Locations
- Wake Forest Baptist Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Adaptive Pressure Control
Assist Volume Control
Arm Description
The Adaptive Pressure Control arm is the baseline mode/protocol for medical intensive care unit mechanical ventilation
The assist volume control arm is the new protocol that will be implemented and tested for feasibility
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Percentage of mode crossover
A secondary feasibility outcome will include <10% crossover to the alternative mode
exhaled tidal volume
exhaled tidal volume will be compared between modes using data extracted from the critical care data capsule.
Number of ventilator free days
vent free days will be compared between the modes using data from the critical care data analytics platform
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
Full Information
NCT ID
NCT03909854
First Posted
April 8, 2019
Last Updated
July 5, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03909854
Brief Title
Pragmatic Investigation of Volume Targeted Ventilation-1
Acronym
PIVOT-1
Official Title
Pragmatic Investigation of Volume Targeted Ventilation-1 (PIVOT-1)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
November 12, 2019 (Actual)
Study Completion Date
February 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS), Ventilator Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Before-and-after trial design of adaptive pressure control and assist volume control
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adaptive Pressure Control
Arm Type
Active Comparator
Arm Description
The Adaptive Pressure Control arm is the baseline mode/protocol for medical intensive care unit mechanical ventilation
Arm Title
Assist Volume Control
Arm Type
Active Comparator
Arm Description
The assist volume control arm is the new protocol that will be implemented and tested for feasibility
Intervention Type
Procedure
Intervention Name(s)
mode of mechanical ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients receiving Assist Volume Control
Description
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
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
assist volume control duration
Description
A secondary feasibility outcome will be >70% of ventilated time on Assist Volume Control during the first 24 hours of mechanical ventilation.
Time Frame
24 hours
Title
Percentage of mode crossover
Description
A secondary feasibility outcome will include <10% crossover to the alternative mode
Time Frame
2 weeks
Title
exhaled tidal volume
Description
exhaled tidal volume will be compared between modes using data extracted from the critical care data capsule.
Time Frame
2 weeks
Title
Number of ventilator free days
Description
vent free days will be compared between the modes using data from the critical care data analytics platform
Time Frame
28 days
Title
intensive care length of stay
Description
intensive care unit length of stay will be compared between the modes using data from the critical care data analytics platform
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Gibbs, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Pragmatic Investigation of Volume Targeted Ventilation-1
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