Goal of Open Lung Ventilation in Donors

NCT03439995 | Terminated DMC

• 1 other identifier: R01HL126176
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 4

Brief Summary

The primary goal of this study is to assess whether ventilation of deceased organ donors with an open lung protective ventilatory strategy will improve donor lung utilization rates and donor oxygenation compared to a conventional ventilatory strategy.

Conditions

Brain Death; Organ Donation; Organ Transplant Failure or Rejection

Outcome Measures

Primary Outcomes (1)

• Donor lung utilization rate

  Percent of donor lungs procured and transplanted into recipient

  during donor management period (usually 12-48 hours)

Secondary Outcomes (6)

• Donor lung utilization in likely donors

  during donor management period (usually 12-48 hours)

• Donor oxygenation

  during donor management period (usually 12-48 hours)

• Donor static compliance of the respiratory system

  during donor management period (usually 12-48 hours)

• Donor radiographic atelectasis scoring

  during donor management period (usually 12-48 hours)

• Recipient primary graft dysfunction

  72 hours after transplant

Study Arms (2)

Open Lung Protective Ventilation

EXPERIMENTAL

Volume cycled assist control ventilation with tidal volume 8 cc/kg predicted body weight, PEEP 10 cm water (H2O), recruitment maneuvers every 8 hours and after any ventilator disconnect

Other: Open lung protective ventilation

Conventional Ventilation

ACTIVE COMPARATOR

Volume cycled assist control ventilation with tidal volume 10 cc/kg predicted body weight, PEEP 5 cm H2O, recruitment maneuvers after any ventilator disconnect

Other: Conventional ventilation

Interventions

Open lung protective ventilation OTHER

Higher PEEP, lower tidal volume mechanical ventilation

Open Lung Protective Ventilation

Conventional ventilation OTHER

Lower PEEP, standard tidal volume mechanical ventilation

Conventional Ventilation

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Brain death
• Authorization for research
• ≥13 years of age

You may not qualify if:

• Arterial/Inspired oxygen ratio (PaO2/FiO2) ≤ 150 mmHg
• PaO2/FiO2 ≥ 400 mmHg
• BMI \> 40
• Hepatitis B surface antigen positive
• Hepatitis C positive
• Failure to complete donation process
• Hemodynamic instability

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• University of California, San Francisco: collaborator
• University of California, Los Angeles: collaborator
• Stanford University: collaborator
• Donor Network West: collaborator

Study Sites (4)

UCLA

Los Angeles, California, 90095, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Donor Network West

San Ramon, California, 94583, United States

Location

Related Publications (2)

• Mascia L, Pasero D, Slutsky AS, Arguis MJ, Berardino M, Grasso S, Munari M, Boifava S, Cornara G, Della Corte F, Vivaldi N, Malacarne P, Del Gaudio P, Livigni S, Zavala E, Filippini C, Martin EL, Donadio PP, Mastromauro I, Ranieri VM. Effect of a lung protective strategy for organ donors on eligibility and availability of lungs for transplantation: a randomized controlled trial. JAMA. 2010 Dec 15;304(23):2620-7. doi: 10.1001/jama.2010.1796.

  PMID: 21156950 BACKGROUND

• Ware LB, Koyama T, Shaver CM, Swain S, Nguyen J, Salehi A, Dhillon G, Wickersham N, Maheshwari J, Singer JP, Weigt SS, Kukreja J, Matthay MA. A randomized trial of open lung protective ventilation compared to conventional mechanical ventilation in deceased organ donors. J Heart Lung Transplant. 2025 Aug;44(8):1251-1259. doi: 10.1016/j.healun.2025.03.027. Epub 2025 Apr 3.

  PMID: 40187505 DERIVED

MeSH Terms

Conditions

Brain Death; Rejection, Psychology

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Lorraine B Ware, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes in donors and lung transplant recipients will be done by assessors who are blinded to ventilator treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Enrolled donors will be randomly assigned to two different modes of mechanical ventilation for the duration of donor management

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: February 20, 2018
• Study Start: July 9, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)