CompletedInterventionalNot ApplicableUpdated May 10, 2022
Early Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury | NCT01581229 | Trialant
CompletedInterventionalNot ApplicableUpdated Nov 21, 2018
Early Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury
ClinicalTrials.gov ID
NCT01581229
Lead Sponsor
Beijing HospitalOTHER_GOV
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
204Actual
Last Update Posted
Nov 21, 2018Actual
Start Date
Jun 2012
Primary Completion Date
Dec 2016Actual
Completion Date
Dec 2016Actual
Brief Summary
To assess the safety and efficacy of noninvasive positive pressure ventilation for patients with intro-pulmonary pulmonary acute lung injury and compare this with high-concentration oxygen therapy.
Acute Lung Injury
noninvasive positive pressure ventilation
oxygen therapy
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acute onset;
a clinical presentation of respiratory distress;
arterial oxygen tension/inspired oxygen fraction (PaO2/FIO2) < 300 mmHg but > 200 mmHg while breathing oxygen delivered by a conventional Venturi device at a maximum concentration (50%);
presence of bilateral pulmonary infiltrates on posteroanterior chest radiograph;
no evidence of left heart failure as assessed by echocardiography and/or a pulmonary artery wedge pressure of <18 mm Hg.
the cause of ALI is consider to be intro-pulmonary.
Exclusion Criteria:
age <18 yrs;
Glasgow Coma Scale < 11;
airway or facial injury;
pneumothorax or pneumomediastinum;
unable to spontaneously clear secretions from the airways;
cardiogenic shock or severe hemodynamic instability (systolic blood pressure <90 mmHg associated with decreased urinary output (<20 mL.h-1) despite fluid repletion and use of vasoactive agents) of other causes;
severe ventricular arrhythmia or unstable myocardial ischemia;
severe organ dysfunction (Sequential Organ Failure Assessment score > 3);
end-stage patients who were expected to survive < 6 months;
severe abdominal distension;
refusal to receive NPPV;
the cause of ALI is consider to be extrapulmonary;