NCT01391481

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

The Randomized Controlled Trial (RCT) on the Vaporized Perfluorocarbon (PFC) Inhalation Treatment of Acute Respiratory Distress Syndrome With the Invasive Mechanical Ventilation（IMV）

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Based on the invasive mechanical ventilation (IMV) treatment of ALI/ARDS, the therapeutic action of vaporized PFC inhalation will be evaluated on the treatment of ALI/ARDS patients, and the safety of vaporized PFC inhalation on the treatment of ALI/ARDS. The Test group will make a timing and fix quantify inhalation of PFC, while the control group will be treated with the inhalation of water for injection. The general condition of patients will be assessed by monitoring their vital signs, hematology testing and APACHE II score, etc. Main outcome measures include the oxygenation index, respiratory mechanics; secondary outcomes include ventilator-free days, 28-day mortality and so on.

Conditions

• Respiratory Distress Syndrome, Adult
• Acute Lung Injury

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-04-01
• Completion: 2015-04-01
• First posted: 2011-07-12
• Last updated: 2012-04-10

Locations

2 sites across 1 country: China