Respiratory FailurePIVOT-1NCT03909854

Pragmatic Investigation of Volume Targeted Ventilation-1

A study testing mode of mechanical ventilation in people with Respiratory Failure and Acute Respiratory Distress Syndrome (ARDS), run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS), Ventilator Lung
What is being tested?: mode of mechanical ventilation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 139 participants
Where: 1 siteUnited States
Study dates: 9 Sep 2019to 20 Feb 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Acute Respiratory Failure requiring mechanical ventilation medical intensive care unit admission

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Pragmatic Investigation of Volume Targeted Ventilation-1 (PIVOT-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.

Read the 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.

Conditions: Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS), Ventilator Lung
Being tested: mode of mechanical ventilation
Medical subject headings: Respiratory Insufficiency, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mode of mechanical ventilationProcedure or surgery
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.

Study groups in NCT03909854
Study group	Role	What they receive
Adaptive Pressure Control	Active comparator	The Adaptive Pressure Control arm is the baseline mode/protocol for medical intensive care unit mechanical ventilation Receives: Procedure: mode of mechanical ventilation
Assist Volume Control	Active comparator	The assist volume control arm is the new protocol that will be implemented and tested for feasibility Receives: Procedure: mode of mechanical ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 1 hour

Secondary outcomes (5)

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.
Measured: 24 hours
Percentage of mode crossover
A secondary feasibility outcome will include <10% crossover to the alternative mode
Measured: 2 weeks
exhaled tidal volume
exhaled tidal volume will be compared between modes using data extracted from the critical care data capsule.
Measured: 2 weeks
Number of ventilator free days
vent free days will be compared between the modes using data from the critical care data analytics platform
Measured: 28 days
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
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 201920 Feb 2020

First posted10 Apr 2019
Study start9 Sep 2019
Primary completion12 Nov 2019
Study completion20 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Respiratory FailureStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Before-and-after trial design of adaptive pressure control and assist volume control
Masking: None (open label)
Enrolment: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03909854
Sponsor's protocol ID: IRB00055128
Acronym: PIVOT-1
Status last verified: Jan 2023
First submitted: 8 Apr 2019
Last updated: 7 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 23631814
Mireles-Cabodevila E, Chatburn RL. Work of breathing in adaptive pressure control continuous mandatory ventilation. Respir Care. 2009 Nov;54(11):1467-72.
PubMed 19863830
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.
PubMed 23963122
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.
PubMed 10793162
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.
PubMed 27898439
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.
PubMed 17417981
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.
PubMed 27598383
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.
PubMed 16318643
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.
PubMed 27786562
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.
PubMed 30357256
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.
PubMed 24811940
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.
PubMed 29485925
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.
PubMed 30779528
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.
PubMed 19664226
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.
PubMed 28549929

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Respiratory Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pragmatic Investigation of Volume Targeted Ventilation-1 (PIVOT-1)
ClinicalTrials.gov ID: NCT03909854
Acronym / sponsor ID: PIVOT-1 / IRB00055128
Conditions: Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS), Ventilator Lung
Study type: Interventional
Recruitment status: Completed
Enrolment: 139 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: 9 Sep 2019 (actual)
Primary completion: 12 Nov 2019 (actual)
Study completion: 20 Feb 2020 (actual)
First posted: 10 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: Before-and-after trial design of adaptive pressure control and assist volume control

Arm	Type	Receives
Adaptive Pressure Control	Active comparator	Procedure: mode of mechanical ventilationThe Adaptive Pressure Control arm is the baseline mode/protocol for medical intensive care unit mechanical ventilation
Assist Volume Control	Active comparator	Procedure: mode of mechanical ventilationThe assist volume control arm is the new protocol that will be implemented and tested for feasibility

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Acute Respiratory Failure requiring mechanical ventilation medical intensive care unit admission

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mode of mechanical ventilationAdaptive 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.	Procedure or surgery	Adaptive Pressure Control, Assist Volume Control

Primary outcome

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

5 secondary outcomes

assist volume control duration
Time frame: 24 hours
Percentage of mode crossover
Time frame: 2 weeks
exhaled tidal volume
Time frame: 2 weeks
Number of ventilator free days
Time frame: 28 days
intensive care length of stay
Time frame: 28 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
Background: PubMed 23631814Esteban 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.
Background: PubMed 19863830Mireles-Cabodevila E, Chatburn RL. Work of breathing in adaptive pressure control continuous mandatory ventilation. Respir Care. 2009 Nov;54(11):1467-72.
Background: PubMed 23963122Wunsch 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.
Background: PubMed 10793162Acute 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.
Background: PubMed 27898439Shah 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.
Background: PubMed 17417981Branson 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.
Background: PubMed 27598383Figueroa-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.
Background: PubMed 16318643Kallet 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.
Background: PubMed 27786562Yoshida 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.
Background: PubMed 30357256Writing 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.
Background: PubMed 24811940Serpa 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.
Background: PubMed 29485925Semler 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kevin Gibbs, MD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients receiving Assist Volume Control (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03909854, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.