Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation

NYU Langone Health

Status: Withdrawn

Conditions: Acute Respiratory Distress Syndrome

Treatments: Other: Esophageal Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT05675696

22-00695

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

ARDS Patients Intubated on Mechanical Ventilation

Experimental group

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.

Treatment:

Other: Esophageal Catheter