Pragmatic Investigation of Volume Targeted Ventilation-1

Not Applicable

Completed

• Conditions: Ventilator Lung; Respiratory Failure; Acute Respiratory Distress Syndrome (ARDS)
• Interventions: Procedure: mode of mechanical ventilation

• Registration Number: NCT03909854
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-10
• Study Start: 2019-09-09
• Primary Completion: 2019-11-12
• Study Completion: 2020-02-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-07-05
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

Acute Respiratory Failure requiring mechanical ventilation medical intensive care unit admission

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Exclusion Criteria

chronic mechanical ventilation clinician use of non-volume-targeted ventilation as initial mode

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Assist Volume Control	mode of mechanical ventilation	The assist volume control arm is the new protocol that will be implemented and tested for feasibility
Adaptive Pressure Control	mode of mechanical ventilation	The Adaptive Pressure Control arm is the baseline mode/protocol for medical intensive care unit mechanical ventilation

Primary Outcome Measures

Name	Time	Method
Percentage of patients receiving Assist Volume Control	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 Outcome Measures

Name	Time	Method
exhaled tidal volume	2 weeks	exhaled tidal volume will be compared between modes using data extracted from the critical care data capsule.
intensive care length of stay	28 days	intensive care unit length of stay will be compared between the modes using data from the critical care data analytics platform
assist volume control duration	24 hours	A secondary feasibility outcome will be \>70% of ventilated time on Assist Volume Control during the first 24 hours of mechanical ventilation.
Number of ventilator free days	28 days	vent free days will be compared between the modes using data from the critical care data analytics platform
Percentage of mode crossover	2 weeks	A secondary feasibility outcome will include \<10% crossover to the alternative mode

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States