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

• Status: Unknown status
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese PLA General Hospital
• Collaborators: 309th Hospital of Chinese People's Liberation Army; Air Force General Hospital of the PLA; Beijing Shijitan Hospital; Beijing Shijitan Hospital, Capital Medical University; First Hospitals affiliated to the China PLA General Hospital; General Hospital of Chinese Armed Police Forces; The 306 Hospital of People's Liberation Army; The Second Artillery General Hospital

Criteria

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