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

Chinese PLA General Hospital (301 Hospital)

Status and phase

Unknown

Phase 2

Conditions

Respiratory Distress Syndrome, Adult

Acute Lung Injury

Treatments

Drug: Sterile Water for Injection

Drug: Perfluorocarbon

Study type

Interventional

Funder types

Other

Identifiers

NCT01391481

PLAGH-PFC

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age: 18-75 years old
Some clear risk aetiological agents of acute respiratory distress syndrome
Acute onset, with corresponding clinical manifestations
PaO2/FiO2 ≤ 300mmHg
Chest radiograph or chest computerized tomography prompting bilateral pulmonary infiltrate shadow
pulmonary capillary wedge pressure (PCWP) ≤ 18 mmHg or clinical cardiogenic pulmonary edema can be excluded
respiratory rate (RR) ≥ 30bpm and (or) respiratory distress
requiring tracheal intubation or tracheostomy for invasive mechanical ventilation
or have received invasive mechanical ventilation time ≤ 3 days

Exclusion criteria

Age: < 18 years old or > 75 years old
During the early stage of the treatment, the use of mechanical ventilation for more than 3 days other than ALI/ARDS for reasons
Lung parenchyma and airway surgery carried out within 30 days of the screening period
Severe arrhythmia and myocardial ischemia after cardiopulmonary resuscitation
Systolic blood pressure < 90 mm Hg, and can not maintain its stability with intravenous infusion and vasopressor drugs
Intubation due to interstitial lung disease (E.g., sarcoidosis, idiopathic pulmonary fibrosis)
Any active pneumothorax or mediastinal emphysema
Risk factors leading to the death within 3 months in addition to ALI/ARDS during the screening period (E.g., end-stage cancer)
Of perfluorocarbons' allergies
Pregnant, breastfeeding women
Attending other clinical trial within 30 days of the screening period
Severe organ dysfunction (Marshall score ≥ 3 or Sequential Organ Failure Assessment（SOFA） score≥ 3, including serious liver and kidney dysfunction, upper gastrointestinal hemorrhage, etc.)
Acute Physiology and Chronic Health Evaluation（APACHE） II score ≥ 30, high risk of death
The researchers consider other situations not suitable for the case to participate in the study