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OpenTrials
Completed

NCT Number: NCT01581229

Early Use of Noninvasive Positive Pressure Ventilation for Intro-pulmonary Acute Lung Injury

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Hospital of the Ministry of Health

Beijing, Beijing Municipality, 100020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • unable to cooperate with NPPV application;
  • active upper gastrointestinal bleeding.

Treatment and study plan

noninvasive positive pressure ventilation

Procedure

Patients in the NPPV group are ventilated using the CPAP or bilevel positive airways pressure S/T mode.

Oxygen Therapy

Procedure

In the control group, Venturi masks are used to maintain SpO2 at 92% to 96% by adjusting the oxygen flow rates.

Primary outcomes

  1. numbers of patients who met the intubation criteria

    Time frame: 1 year

  2. the numbers of patients who are actually intubated

    Time frame: 1 year

Secondary outcomes

  1. inhospital mortalities

    Time frame: 1 year

  2. intensive care unit mortalities

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Beijing Hospital

Other Gov

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 20, 2012
Registry last updated
Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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