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NCT Number: NCT03909854

Pragmatic Investigation of Volume Targeted Ventilation-1

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.

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Key information

Conditions

Respiratory Failure Acute Respiratory Distress Syndrome (ARDS) Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Insufficiency Respiratory Tract Diseases Ventilator Lung

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mode of mechanical ventilation

Procedure

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 outcomes

  1. 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

  1. assist volume control duration

    Time frame: 24 hours

    A secondary feasibility outcome will be >70% of ventilated time on Assist Volume Control during the first 24 hours of mechanical ventilation.

  2. Percentage of mode crossover

    Time frame: 2 weeks

    A secondary feasibility outcome will include <10% crossover to the alternative mode

  3. exhaled tidal volume

    Time frame: 2 weeks

    exhaled tidal volume will be compared between modes using data extracted from the critical care data capsule.

  4. Number of ventilator free days

    Time frame: 28 days

    vent free days will be compared between the modes using data from the critical care data analytics platform

  5. intensive care length of stay

    Time frame: 28 days

    intensive care unit length of stay will be compared between the modes using data from the critical care data analytics platform

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Acronym: PIVOT-1

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 10, 2019
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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