Non-Positive Pressure Ventilation in Hypoxemic Patients. A Randomized Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- mortality rates
Study Overview
Brief Summary
The study is aimed to assess the possible benefit of non-positive pressure mechanical support in front of conventional ventilation in patients admitted to the intensive care unit (ICU) because of pure hypoxemic respiratory failure.
Detailed Description
Pure hypoxemic patients admitted to intensive care unit in a teaching hospital have been randomized to be treated by conventional ventilatory support or non-positive mechanical ventilation support. Those patients who did not benefit from the experimental non-positive ventilatory support, were intubated and conventionally mechanically ventilated and discarded for analysis. The primary outcome was mortality rate in both groups, and secondary outcomes were length of stay, improvement of oxygenation, and reduced complications rates.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •dyspnea with respiratory rates higher than 35 p.m.
- •pO2 < 65 mmHg
- •paO2/FiO2 < 250
Exclusion Criteria
- •respiratory or cardiac arrest
- •gastrointestinal bleeding
- •hemodynamic instability
- •face surgery
- •upper airway obstruction
- •inability for active cooperation
- •need for airway protection
- •exacerbation of COPD
- •decrease of conscious level
- •acute pulmonary cardiogenic oedema
Outcomes
Primary Outcomes
mortality rates
Time Frame: patient hospital discharge
Secondary Outcomes
- oxygenation improve(patient hospital discharge)
- diminishing of tracheal intubation incidence(patient hospital discharge)
- ICU and Post ICU hospital length of stay(patient hospital discharge)