Prospective Randomized Trial of Total Lung Protective Ventilation in Adult VV-ECMO Patients With Severe ARDS

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07790133
Status
Not Yet Recruiting

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Conditions

  • ARDS (Acute Respiratory Distress Syndrome)
  • VV ECMO

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mechanical Power Targeted Ventilation — PROCEDURE
    For patients assigned to the intervention arm, the patient will be placed on volume control (VC) or pressure control (PC) ventilation with either an initial tidal volume of 3-4cc/kg predicted body weight (PBW) (for VC) or inspiratory pressure required to reach the same tidal volume goal (for PC), FiO2 set between 0.30-0.50, and PEEP of at least 10. This tidal volume or inspiratory pressure, for VC and PC respectively, will then be titrated down to meet a goal plateau pressure of less than or equal to 24 cmH2O, and a target driving pressure no greater than 14 cmH2O. Finally, the respiratory rate will then be titrated between 1 and 15 to meet the specified mechanical power goal range. Once the respiratory rate has been lowered to 8, tidal volumes will be lowered to 3cc/kg PBW prior to further reductions in respiratory rate. Mechanical power (MP) will be calculated every two hours and adjusted as needed to stay within the goal MP range until pre-defined weaning criteria are met.

Study Details

The purpose of this study is to find a better way to protect the lungs of patients with Acute Respiratory Distress Syndrome (ARDS) who are being treated with a mechanical ventilator in addition to an extracorporeal membrane oxygenation (ECMO) machine. ARDS is a serious lung condition that makes it hard to breathe. People with ARDS often need care in the intensive care unit (ICU) and can become very sick with high mortality rates despite optimal care. Doctors usually support patients with through ARDS with a breathing machine called a ventilator. The ventilator helps lungs imitate taking small breaths to help protect the lungs from more damage, however ventilator induced lung injury (VILI) can still contribute significantly to organ injury. For patients in whom a ventilator is not enough support due to the severity of their lung disease, veno-venous (VV) ECMO can fully support the lungs while they recover. In these sickest patients, it is important to avoid causing more lung damage with the ventilator. Protecting the lungs may help them heal faster and may also help protect other parts of the body. More people are now being treated with VV ECMO, but there is still not enough research to know which ventilator settings are safest and work best. Most current recommendations are based on doctors' experience instead of research studies. This study will help researchers learn the best way to use ventilators for patients on VV ECMO and improve their recovery.

Key Dates

First listed
Aug 27, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Routine Care
    This arm will receive routine care for all aspects of care including ECMO and mechanical ventilation as decided by the attending physician.
  • Experimental: Targeted Intervention
    This group will have their mechanical ventilator settings adjusted by the study team to a target mechanical power of between 2-4 J/minute, closely mimicking the mechanical power of that required for healthy adult breathing. The adjustments will be made using the mechanical power ventilation formula with information specific to the person, titrating each of the variables historically associated with ventilator induced lung injury in tandem. The ventilator will be monitored and adjusted as needed every 2 hours for 7 days while patients are on ECMO.

Primary Outcome Measure

Feasibility of prospective, randomized mechanical power-based strategy to establish a causal relationship between MP and clinical outcomes. [ Time Frame: From enrollment to the end of the intervention window of 7 days. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Department of Anesthesiology
[email protected]
(434) 924-9508
Jenny Phillips, RN, CCRC
[email protected]
434-297-8136
Ryan Lee, MD (PRINCIPAL_INVESTIGATOR)
Alexandra Kadl, MD (SUB_INVESTIGATOR)
Jared Beller, MD (SUB_INVESTIGATOR)

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