Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05675696
• Other study ID #: 22-00695
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Beno Oppenheimer
• Phone: 917-797-2128
• Email: Beno.Oppenheimer[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Esophageal Catheter
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.

Locations

Country	Name	City	State
United States	Tisch Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to Hour 2 (Day 1)
Primary	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.	Up to Hour 2 (Day 1)
Primary	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.	Up to Hour 2 (Day 1)
Primary	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.	Up to Hour 2 (Day 1)
Secondary	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).	Up to Hour 2 (Day 1)
Secondary	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).	Up to Hour 2 (Day 1)
Secondary	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).	Up to Hour 2 (Day 1)
Secondary	Oxygen Saturation	Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin in the blood.	Up to Hour 2 (Day 1)
Secondary	PaO2/FiO2 (P/F) Ratio	The P/F ratio is the arterial partial pressure of oxygen (PaO2) divided by the inspired oxygen concentration (FiO2).	Up to Hour 2 (Day 1)