Regional Lung Inflammation and Expansion in Mechanically Ventilated Patients - a PET/CT Study

NCT ID: NCT01806532

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2019-03-31

Brief Summary

The goal of this study is to investigate acute respiratory distress syndrome (ARDS) and septic lung with positron emission tomography (PET) imaging and to examine the distribution of inflammation, as measured by neutrophil metabolic activity.

Conditions

Respiratory Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

18F-FDG PET-CT

A total of 10 patients with acute respiratory distress syndrome (ARDS) will be imaged with 2-18F-fluoro-2-deoxy-D-glucose (18F-FDG) and PET-CT scan.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Group 1

• Mechanically ventilated patients scheduled to undergo a CT scanning for their routine clinical care
• More than 24 hours of mechanical ventilation
• Less than 15 days of mechanical ventilation if patient presents ALI/ARDS (in order to exclude the late, fibrotic, stage of ARDS)

Group 2

• Mechanically ventilated patients with a diagnosis of sepsis
• Less than 96 hours of mechanical ventilation

Exclusion Criteria

• Age less than 18 years
• Hemodynamic instability, defined as: systolic blood pressure (SBP) < 90 mmHg that is not adequately stabilized by vasopressors or inotropic agents. For these purposes, SBP will not be considered "adequately stabilized" if the dose of the vasopressor/inotrope has not been stable for at least one hour
• Hypoxemia, defined as: PaO2 < 70 mmHg on an inspired oxygen fraction (FiO2) greater than or equal to 0.9; FiO2 greater than or equal to 0.8 at baseline
• Hemodynamic and/or respiratory instability (as defined, respectively, in 2 and 3), that develop when the patient is mobilized during routine nursing care such as repositioning/washing the patient or changing their bed linens
• Hemodynamic and/or respiratory instability (as defined, respectively, in 2 and 3), that develop when a 15-25 second respiratory pause is introduced as per the study protocol. This will be tested by inducing such a pause prior to transporting the patient
• Patients must be deemed by the treating clinical staff to be able to tolerate leaving the ICU for 90 minutes (40-60 minute imaging time + 30 minute safety margin). Treating MD, RT, and RN must all agree that the patient is stable for transport
• Any acute or chronic condition which, in the opinion of the investigator, might confound the imaging measurements (such as, but not limited to, severe bronchospasm, pulmonary infection, and lung tumor)
• "Air leaks" requiring tube thoracostomy (e.g., pneumothorax, bronchopleural fistula)
• Pregnancy (since this is a study which would expose a fetus to radiation risk)
• Patients who have neither an arterial nor a central venous line at the time of the enrollement

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marcos Vidal Melo

Associate Professor, Harvard University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Marcos Vidal Melo, MD, PhD

Role: CONTACT

VidalMelo.Marcos@mgh.harvard.edu

617-726-8980

Facility Contacts

Marcos Vidal Melo, MD, PhD

Role: primary

VidalMelo.Marcos@mgh.harvard.edu

617-726-8980

Other Identifiers

2008P000561

Identifier Type: -

Identifier Source: org_study_id