search
Back to results

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
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 8, 2019
Last Updated
July 5, 2023
Sponsor
Wake Forest University Health Sciences
search

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
Citations:
PubMed Identifier
23631814
Citation
Esteban A, Frutos-Vivar F, Muriel A, Ferguson ND, Penuelas O, Abraira V, Raymondos K, Rios F, Nin N, Apezteguia C, Violi DA, Thille AW, Brochard L, Gonzalez M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Pelosi P, Soto L, Tomicic V, D'Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bulow HH, Zeggwagh AA, Anzueto A. Evolution of mortality over time in patients receiving mechanical ventilation. Am J Respir Crit Care Med. 2013 Jul 15;188(2):220-30. doi: 10.1164/rccm.201212-2169OC.
Results Reference
background
PubMed Identifier
19863830
Citation
Mireles-Cabodevila E, Chatburn RL. Work of breathing in adaptive pressure control continuous mandatory ventilation. Respir Care. 2009 Nov;54(11):1467-72.
Results Reference
background
PubMed Identifier
23963122
Citation
Wunsch H, Wagner J, Herlim M, Chong DH, Kramer AA, Halpern SD. ICU occupancy and mechanical ventilator use in the United States. Crit Care Med. 2013 Dec;41(12):2712-9. doi: 10.1097/CCM.0b013e318298a139.
Results Reference
background
PubMed Identifier
10793162
Citation
Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
Results Reference
background
PubMed Identifier
27898439
Citation
Shah FA, Girard TD, Yende S. Limiting sedation for patients with acute respiratory distress syndrome - time to wake up. Curr Opin Crit Care. 2017 Feb;23(1):45-51. doi: 10.1097/MCC.0000000000000382.
Results Reference
background
PubMed Identifier
17417981
Citation
Branson RD, Chatburn RL. Controversies in the critical care setting. Should adaptive pressure control modes be utilized for virtually all patients receiving mechanical ventilation? Respir Care. 2007 Apr;52(4):478-85; discussion 485-8.
Results Reference
background
PubMed Identifier
27598383
Citation
Figueroa-Casas JB, Montoya R. Effect of Tidal Volume Size and Its Delivery Mode on Patient-Ventilator Dyssynchrony. Ann Am Thorac Soc. 2016 Dec;13(12):2207-2214. doi: 10.1513/AnnalsATS.201605-362OC.
Results Reference
background
PubMed Identifier
16318643
Citation
Kallet RH, Campbell AR, Dicker RA, Katz JA, Mackersie RC. Work of breathing during lung-protective ventilation in patients with acute lung injury and acute respiratory distress syndrome: a comparison between volume and pressure-regulated breathing modes. Respir Care. 2005 Dec;50(12):1623-31.
Results Reference
background
PubMed Identifier
27786562
Citation
Yoshida T, Fujino Y, Amato MB, Kavanagh BP. Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management. Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. doi: 10.1164/rccm.201604-0748CP.
Results Reference
background
PubMed Identifier
30357256
Citation
Writing Group for the PReVENT Investigators; Simonis FD, Serpa Neto A, Binnekade JM, Braber A, Bruin KCM, Determann RM, Goekoop GJ, Heidt J, Horn J, Innemee G, de Jonge E, Juffermans NP, Spronk PE, Steuten LM, Tuinman PR, de Wilde RBP, Vriends M, Gama de Abreu M, Pelosi P, Schultz MJ. Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without ARDS: A Randomized Clinical Trial. JAMA. 2018 Nov 13;320(18):1872-1880. doi: 10.1001/jama.2018.14280.
Results Reference
background
PubMed Identifier
24811940
Citation
Serpa Neto A, Simonis FD, Barbas CS, Biehl M, Determann RM, Elmer J, Friedman G, Gajic O, Goldstein JN, Horn J, Juffermans NP, Linko R, de Oliveira RP, Sundar S, Talmor D, Wolthuis EK, de Abreu MG, Pelosi P, Schultz MJ. Association between tidal volume size, duration of ventilation, and sedation needs in patients without acute respiratory distress syndrome: an individual patient data meta-analysis. Intensive Care Med. 2014 Jul;40(7):950-7. doi: 10.1007/s00134-014-3318-4. Epub 2014 May 9.
Results Reference
background
PubMed Identifier
29485925
Citation
Semler MW, Self WH, Wanderer JP, Ehrenfeld JM, Wang L, Byrne DW, Stollings JL, Kumar AB, Hughes CG, Hernandez A, Guillamondegui OD, May AK, Weavind L, Casey JD, Siew ED, Shaw AD, Bernard GR, Rice TW; SMART Investigators and the Pragmatic Critical Care Research Group. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):829-839. doi: 10.1056/NEJMoa1711584. Epub 2018 Feb 27.
Results Reference
background
PubMed Identifier
30779528
Citation
Casey JD, Janz DR, Russell DW, Vonderhaar DJ, Joffe AM, Dischert KM, Brown RM, Zouk AN, Gulati S, Heideman BE, Lester MG, Toporek AH, Bentov I, Self WH, Rice TW, Semler MW; PreVent Investigators and the Pragmatic Critical Care Research Group. Bag-Mask Ventilation during Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2019 Feb 28;380(9):811-821. doi: 10.1056/NEJMoa1812405. Epub 2019 Feb 18.
Results Reference
background
PubMed Identifier
19664226
Citation
Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
Results Reference
background
PubMed Identifier
28549929
Citation
Zuidgeest MGP, Goetz I, Groenwold RHH, Irving E, van Thiel GJMW, Grobbee DE; GetReal Work Package 3. Series: Pragmatic trials and real world evidence: Paper 1. Introduction. J Clin Epidemiol. 2017 Aug;88:7-13. doi: 10.1016/j.jclinepi.2016.12.023. Epub 2017 May 24.
Results Reference
background
PubMed Identifier
28716504
Citation
Meinecke AK, Welsing P, Kafatos G, Burke D, Trelle S, Kubin M, Nachbaur G, Egger M, Zuidgeest M; work package 3 of the GetReal consortium. Series: Pragmatic trials and real world evidence: Paper 8. Data collection and management. J Clin Epidemiol. 2017 Nov;91:13-22. doi: 10.1016/j.jclinepi.2017.07.003. Epub 2017 Jul 14.
Results Reference
background
PubMed Identifier
30308549
Citation
Sjoding MW, Gong MN, Haas CF, Iwashyna TJ. Evaluating Delivery of Low Tidal Volume Ventilation in Six ICUs Using Electronic Health Record Data. Crit Care Med. 2019 Jan;47(1):56-61. doi: 10.1097/CCM.0000000000003469.
Results Reference
background

Learn more about this trial

Pragmatic Investigation of Volume Targeted Ventilation-1

We'll reach out to this number within 24 hrs