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Perfluorocarbon (PFC) Inhalation Treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome

NCT01391481 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-04-10

No results posted yet for this study

Summary

PFCs (perfluorocarbons, PFC), an ideal liquid respiratory media, has special chemical and biological properties, including high solubility of gas, swiftness of carrying and release, low surface tension, high proportion, almost non-absorbing and non-metabolic characteristics in the body. On the basis of the strong animal data suggesting the efficacy of PFC vapor inhalation in models of lung injury, we performed a randomized clinical trial comparing PFC vapor inhalation with conventional mechanical ventilation（CMV）in patients with Acute Lung Injury/Acute Respiratory Distress Syndrome（ALI/ARDS）. The investigators will apply the Invasive Mechanical Ventilation (IMV) to the vaporized perfluorocarbon inhalation, objectively evaluate its curative effect on the acute respiratory distress syndrome, and meanwhile assess the safety of PFC.

Conditions

  • Respiratory Distress Syndrome, Adult
  • Acute Lung Injury

Interventions

DRUG

Perfluorocarbon

Vaporized PFC Inhalation 100ml/8h for 5 days

DRUG

Sterile Water for Injection

Inhalation of Sterile Water for Injection, 100ml/8h for 5 days

Sponsors & Collaborators

  • The Second Artillery General Hospital

    collaborator OTHER

  • The 306 Hospital of People's Liberation Army

    collaborator OTHER

  • First Hospitals affiliated to the China PLA General Hospital

    collaborator OTHER_GOV

  • General Hospital of Chinese Armed Police Forces

    collaborator OTHER

  • Beijing Shijitan Hospital, Capital Medical University

    collaborator OTHER

  • Air Force General Hospital of the PLA

    collaborator OTHER_GOV

  • 309th Hospital of Chinese People's Liberation Army

    collaborator OTHER

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Liangan Chen, M.D. PHD. · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-04-30
Completion
2015-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01391481 on ClinicalTrials.gov