Back to resultsAssessment of Occult Lung Stress During Lung Protective Mechanical Ventilation
Primary Purpose
Acute Respiratory Distress Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Esophageal Catheter
Sponsored by
About this trial
This is an interventional other trial for Acute Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria: Intubated with a diagnosis of ARDS and expected to be ventilated for ≥ 48 hours Meets Berlin criteria for ARDS, with or without underlying chronic lung disease Triggering breaths on the ventilator Treating medical team agrees with patient participation Exclusion Criteria: Known or suspected esophageal abnormalities, craniofacial abnormalities, or upper GI bleed Shock that requires ≥ 2 vasopressors pH on arterial blood gas ≤7.25 Minute ventilation ≥ 14L/min Known or suspected pneumothorax, pneumomediastinum, and/or subcutaneous emphysema Severe ARDS with P/F ratio <60 Pregnancy Currently receiving extracorporeal membrane oxygenation (ECMO) therapy Decision to withhold life-sustaining treatment Patients who are not expected to survive for 24 hours Lack of informed consent
Sites / Locations
- Tisch Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ARDS Patients Intubated on Mechanical Ventilation
Arm Description
ARDS patients in the ICU who are intubated on mechanical ventilation will be included. During ventilation, an esophageal catheter will be used to measure the esophageal pressure, which estimates pleural pressure at the level of the catheter. The esophageal catheter's position will be confirmed by a chest radiograph once inserted. The ventilator settings may be changed to see if these ventilator adjustments can reduce potential lung stress in ARDS patients. There is no set criteria for adjusting the ventilator settings based on the study device, but the goal would be to adjust the volume until the inspiratory effort measured by the catheter disappears so as to protect the patient. A one-to-two-hour study session will be performed for data collection. The esophageal catheter will be removed at the end of the study session or can be left in place for use as a feeding tube if needed for patient care.
Outcomes
Primary Outcome Measures
Transpulmonary Driving Pressure
Transpulmonary driving pressure is the pressure difference between the airway opening and pleural surface. It represents lung stress and is higher with increased spontaneous respiration and work of breathing.
Driving Pressure
Driving pressure is defined as plateau pressure minus positive end-expiratory pressure (PEEP). Driving pressure during mechanical ventilation is directly related to stress forces in the lung.
Work of Breathing (WOB)
WOB is the amount of energy or oxygen (O2) consumption needed by the respiratory muscles to produce enough ventilation and respiration to meet the metabolic demands of the body.
Pressure-Time Product (PTP)
PTP is the product of the average inspiratory pressure (starting from the onset of effort) and the duration of inspiration. The PTP was developed to account for energy expenditures during the dynamic and isometric phases of respiration.
Secondary Outcome Measures
Lung Compliance (C, l)
Lung compliance is calculated as the tidal volume divided by the difference of transpulmonary pressure at end inspiration minus transpulmonary pressure at PEEP:
(C, l) = tidal volume/(transpulmonary pressure at end inspiration - transpulmonary pressure at PEEP).
Expressed in (ml/cmH2O).
Chest Wall Compliance (C, cw)
Chest wall compliance is calculated as the tidal volume divided by the difference of esophageal pressure at end inspiration minus esophageal pressure at PEEP:
(C, cw) = tidal volume/(esophageal pressure at end inspiration - esophageal pressure at PEEP).
Expressed in (ml/cmH2O).
Respiratory System Compliance (C, rs)
Respiratory System Compliance is calculated as the tidal volume divided by the difference of the airway pressure at end inspiration minus airway pressure at PEEP:
(C, rs) = tidal volume/(airway pressure at end inspiration - airway pressure at PEEP).
Expressed in (ml/cmH2O).
Oxygen Saturation
Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood.
PaO2/FiO2 (P/F) Ratio
The P/F ratio is the arterial partial pressure of oxygen (PaO2) divided by the inspired oxygen concentration (FiO2).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05675696
Brief Title
Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation
Official Title
Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
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
The present study will utilize esophageal manometry to measure the presence and magnitude of persistent patient effort during lung protective ventilation, allowing identification and mitigation of occult lung stress.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ARDS Patients Intubated on Mechanical Ventilation
Arm Type
Experimental
Arm Description
ARDS patients in the ICU who are intubated on mechanical ventilation will be included. During ventilation, an esophageal catheter will be used to measure the esophageal pressure, which estimates pleural pressure at the level of the catheter. The esophageal catheter's position will be confirmed by a chest radiograph once inserted. The ventilator settings may be changed to see if these ventilator adjustments can reduce potential lung stress in ARDS patients. There is no set criteria for adjusting the ventilator settings based on the study device, but the goal would be to adjust the volume until the inspiratory effort measured by the catheter disappears so as to protect the patient. A one-to-two-hour study session will be performed for data collection. The esophageal catheter will be removed at the end of the study session or can be left in place for use as a feeding tube if needed for patient care.
Intervention Type
Other
Intervention Name(s)
Esophageal Catheter
Other Intervention Name(s)
PulmoTech Esophageal Pressure System (iEPS)
Intervention Description
Newly designed external monitor that will capture esophageal pressure from a proprietary nasogastric tube combined with simultaneous pressure, flow, and volume measurements from the ventilator tubing.
Primary Outcome Measure Information:
Title
Transpulmonary Driving Pressure
Description
Transpulmonary driving pressure is the pressure difference between the airway opening and pleural surface. It represents lung stress and is higher with increased spontaneous respiration and work of breathing.
Time Frame
Up to Hour 2 (Day 1)
Title
Driving Pressure
Description
Driving pressure is defined as plateau pressure minus positive end-expiratory pressure (PEEP). Driving pressure during mechanical ventilation is directly related to stress forces in the lung.
Time Frame
Up to Hour 2 (Day 1)
Title
Work of Breathing (WOB)
Description
WOB is the amount of energy or oxygen (O2) consumption needed by the respiratory muscles to produce enough ventilation and respiration to meet the metabolic demands of the body.
Time Frame
Up to Hour 2 (Day 1)
Title
Pressure-Time Product (PTP)
Description
PTP is the product of the average inspiratory pressure (starting from the onset of effort) and the duration of inspiration. The PTP was developed to account for energy expenditures during the dynamic and isometric phases of respiration.
Time Frame
Up to Hour 2 (Day 1)
Secondary Outcome Measure Information:
Title
Lung Compliance (C, l)
Description
Lung compliance is calculated as the tidal volume divided by the difference of transpulmonary pressure at end inspiration minus transpulmonary pressure at PEEP:
(C, l) = tidal volume/(transpulmonary pressure at end inspiration - transpulmonary pressure at PEEP).
Expressed in (ml/cmH2O).
Time Frame
Up to Hour 2 (Day 1)
Title
Chest Wall Compliance (C, cw)
Description
Chest wall compliance is calculated as the tidal volume divided by the difference of esophageal pressure at end inspiration minus esophageal pressure at PEEP:
(C, cw) = tidal volume/(esophageal pressure at end inspiration - esophageal pressure at PEEP).
Expressed in (ml/cmH2O).
Time Frame
Up to Hour 2 (Day 1)
Title
Respiratory System Compliance (C, rs)
Description
Respiratory System Compliance is calculated as the tidal volume divided by the difference of the airway pressure at end inspiration minus airway pressure at PEEP:
(C, rs) = tidal volume/(airway pressure at end inspiration - airway pressure at PEEP).
Expressed in (ml/cmH2O).
Time Frame
Up to Hour 2 (Day 1)
Title
Oxygen Saturation
Description
Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood.
Time Frame
Up to Hour 2 (Day 1)
Title
PaO2/FiO2 (P/F) Ratio
Description
The P/F ratio is the arterial partial pressure of oxygen (PaO2) divided by the inspired oxygen concentration (FiO2).
Time Frame
Up to Hour 2 (Day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Intubated with a diagnosis of ARDS and expected to be ventilated for ≥ 48 hours
Meets Berlin criteria for ARDS, with or without underlying chronic lung disease
Triggering breaths on the ventilator
Treating medical team agrees with patient participation
Exclusion Criteria:
Known or suspected esophageal abnormalities, craniofacial abnormalities, or upper GI bleed
Shock that requires ≥ 2 vasopressors
pH on arterial blood gas ≤7.25
Minute ventilation ≥ 14L/min
Known or suspected pneumothorax, pneumomediastinum, and/or subcutaneous emphysema
Severe ARDS with P/F ratio <60
Pregnancy
Currently receiving extracorporeal membrane oxygenation (ECMO) therapy
Decision to withhold life-sustaining treatment
Patients who are not expected to survive for 24 hours
Lack of informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beno Oppenheimer
Phone
917-797-2128
Email
Beno.Oppenheimer@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beno Oppenheimer, MD
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tisch Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beno Oppenheimer
Phone
917-797-2128
Email
Beno.Oppenheimer@nyulangone.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Beno Oppenheimer [Beno.Oppenheimer@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposes to use the data will be granted access upon reasonable request. Requests should be directed to Beno.Oppenheimer@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation
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