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Assessing Ventilator Safety in Patients on Pressure-Support Ventilation (ASOP)

Primary Purpose

Acute Respiratory Failure, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Viasys Avea Ventilator
Philips Respironics NM3 device
Servo U ventilator
Vyaire SmartCath adult nasogastric tube with Esophageal balloon
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Respiratory Failure focused on measuring Self-induced lung injury, Pressure-support ventilation

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients age ≥18 years with acute respiratory failure receiving invasive mechanical ventilation
  • Managed in pressure-support mode of ventilation

Exclusion Criteria:

  • Actively undergoing a spontaneously awakening trial or SAT
  • Patient or surrogate is unable to provide informed consent
  • Currently pregnant
  • Currently incarcerated
  • Acute exacerbation of an obstructive lung disease
  • Known esophageal varices or any other condition for which the attending physician deems an orogastric catheter to be unsafe
  • Esophageal, gastric or duodenal surgical procedures within the last 6 months

Sites / Locations

  • Duke University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute Respiratory Failure

Arm Description

Patients with acute respiratory failure managed with pressure-support ventilation.

Outcomes

Primary Outcome Measures

Respiratory System Driving Pressure measure by Servo Ventilator (DPrs-servo)
Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation.
Respiratory System Driving Pressure measure by Respironics NM3 device (DPrs-NM3)
Driving pressure in centimeters of water measured with Phillips Respironics NM3 device in pressure-support ventilation.
Airway Occlusion Test (AOC)
Maximum negative airway pressure in centimeters of water during an airway occlusion maneuver.
Respiratory System Driving Pressure measured during volume control breath.
Airway driving pressure in centimeters of water measured with inspiratory hold in volume control/assist control.
Transpulmonary Driving pressure measured during volume control breath.
Transpulmonary driving pressure in centimeters of water measured via esophageal balloon with inspiratory hold in volume control/assist control.

Secondary Outcome Measures

Duration of mechanical ventilation
Number of days receiving mechanical ventilation
Duration of intensive care unit admission
Number of days admitted to intensive care unit
Duration of hospital admission
Number of days admitted to hospital
Ventilator Free Days
Number of days free from mechanical ventilation
In-hospital survival
Survival to discharge

Full Information

First Posted
November 8, 2021
Last Updated
September 11, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05125952
Brief Title
Assessing Ventilator Safety in Patients on Pressure-Support Ventilation
Acronym
ASOP
Official Title
Assessing Ventilator Safety in Patients on Pressure-Support Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation. We will describe the relationship between three different assessment methods for risk of self-induced lung injury and compare them to a gold standard measurement.
Detailed Description
Ventilator-induced lung injury (VILI) is known to cause significant morbidity and mortality in patients with acute respiratory failure. Most studies on VILI have involved the effects of inappropriate (often excessive) mechanical ventilator settings. More recently, it has been noted that similar lung damage can be caused by large, patient generated, uncontrolled tidal volumes and driving pressures, which has been termed "self-induced lung injury," or SILI. Pressure-support ventilation (PSV) is a common mechanical ventilation mode often used in patients with active inspiratory efforts to help reduce patient inspiratory work and improve comfort. PSV effectively allows spontaneously breathing patients to determine their breath flow-rate and breath duration, eliminating flow and cycle dyssynchrony. However, pressure support ventilation does not allow for physicians to control tidal volume or driving pressure. The risk of SILI may thus be increased with PSV. Several different methods have been proposed to address these challenges. However, to date none of these methods have been compared to assess for concordance in their ability to indicate an increased risk of self-induced lung injury. ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury
Keywords
Self-induced lung injury, Pressure-support ventilation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute Respiratory Failure
Arm Type
Experimental
Arm Description
Patients with acute respiratory failure managed with pressure-support ventilation.
Intervention Type
Device
Intervention Name(s)
Viasys Avea Ventilator
Intervention Description
Measuring dynamic airway driving pressure and static airway driving pressure during pressure support breath, and static airway driving pressure during a volume control breath. Measuring airway occlusion pressure during pressure support breath.
Intervention Type
Device
Intervention Name(s)
Philips Respironics NM3 device
Intervention Description
Measuring static airway driving pressure during pressure support breath
Intervention Type
Device
Intervention Name(s)
Servo U ventilator
Intervention Description
Measuring static airway driving pressure and p0.1 during pressure support breath.
Intervention Type
Device
Intervention Name(s)
Vyaire SmartCath adult nasogastric tube with Esophageal balloon
Intervention Description
Measuring static and dynamic esophageal driving pressure during pressure support breath, and esophogeal pressure change during airway occlusion maneuver.
Primary Outcome Measure Information:
Title
Respiratory System Driving Pressure measure by Servo Ventilator (DPrs-servo)
Description
Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation.
Time Frame
Study day 1
Title
Respiratory System Driving Pressure measure by Respironics NM3 device (DPrs-NM3)
Description
Driving pressure in centimeters of water measured with Phillips Respironics NM3 device in pressure-support ventilation.
Time Frame
Study day 1
Title
Airway Occlusion Test (AOC)
Description
Maximum negative airway pressure in centimeters of water during an airway occlusion maneuver.
Time Frame
Study day 1
Title
Respiratory System Driving Pressure measured during volume control breath.
Description
Airway driving pressure in centimeters of water measured with inspiratory hold in volume control/assist control.
Time Frame
Study day 1
Title
Transpulmonary Driving pressure measured during volume control breath.
Description
Transpulmonary driving pressure in centimeters of water measured via esophageal balloon with inspiratory hold in volume control/assist control.
Time Frame
Study day 1
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation
Description
Number of days receiving mechanical ventilation
Time Frame
Index hospitalization (up to 28 days)
Title
Duration of intensive care unit admission
Description
Number of days admitted to intensive care unit
Time Frame
Index hospitalization (up to 28 days)
Title
Duration of hospital admission
Description
Number of days admitted to hospital
Time Frame
Index hospitalization (up to 28 days)
Title
Ventilator Free Days
Description
Number of days free from mechanical ventilation
Time Frame
Index hospitalization (up to 28 days)
Title
In-hospital survival
Description
Survival to discharge
Time Frame
Index hospitalization (up to 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients age ≥18 years with acute respiratory failure receiving invasive mechanical ventilation Managed in pressure-support mode of ventilation Exclusion Criteria: Actively undergoing a spontaneously awakening trial or SAT Patient or surrogate is unable to provide informed consent Currently pregnant Currently incarcerated Acute exacerbation of an obstructive lung disease Known esophageal varices or any other condition for which the attending physician deems an orogastric catheter to be unsafe Esophageal, gastric or duodenal surgical procedures within the last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elias H Pratt, MD
Phone
9192060120
Email
elias.pratt@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil R MacIntyre, MD
Organizational Affiliation
Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elias H Pratt, MD
Phone
919-259-3214
Email
elias.pratt@duke.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27842744
Citation
Beitler JR, Malhotra A, Thompson BT. Ventilator-induced Lung Injury. Clin Chest Med. 2016 Dec;37(4):633-646. doi: 10.1016/j.ccm.2016.07.004. Epub 2016 Oct 14.
Results Reference
background
PubMed Identifier
24283226
Citation
Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available. Erratum In: N Engl J Med. 2014 Apr 24;370(17):1668-9.
Results Reference
background
PubMed Identifier
33381233
Citation
Sottile PD, Albers D, Smith BJ, Moss MM. Ventilator dyssynchrony - Detection, pathophysiology, and clinical relevance: A Narrative review. Ann Thorac Med. 2020 Oct-Dec;15(4):190-198. doi: 10.4103/atm.ATM_63_20. Epub 2020 Oct 10.
Results Reference
background
PubMed Identifier
30871304
Citation
Grieco DL, Menga LS, Eleuteri D, Antonelli M. Patient self-inflicted lung injury: implications for acute hypoxemic respiratory failure and ARDS patients on non-invasive support. Minerva Anestesiol. 2019 Sep;85(9):1014-1023. doi: 10.23736/S0375-9393.19.13418-9. Epub 2019 Mar 12.
Results Reference
background
PubMed Identifier
15691390
Citation
Hess DR. Ventilator waveforms and the physiology of pressure support ventilation. Respir Care. 2005 Feb;50(2):166-86; discussion 183-6.
Results Reference
background
PubMed Identifier
27334266
Citation
Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.
Results Reference
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Assessing Ventilator Safety in Patients on Pressure-Support Ventilation

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