Non-Positive Pressure Ventilation in Hypoxemic Patients

Hospital Provincial de Castellon

Status and phase: Completed; Phase 4

Conditions: Acute Respiratory Failure

Treatments: Procedure: non positive pressure mechanical ventilatory support

Study type: Interventional

Funder types: Other

Identifiers

NCT00925860

HGCS-2009-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

non invasive ventilation approach

Experimental group

Description:

pure hypoxemic patients admitted to ICU treated by non-positive pressure mechanical ventilation

Treatment:

Procedure: non positive pressure mechanical ventilatory support

conventionally ventilated

No Intervention group

Description:

pure hypoxemic patients treated by conventional ventilatory support