Non-Positive Pressure Ventilation in Hypoxemic Patients

Phase 4

Completed

• Conditions: Acute Respiratory Failure
• Interventions: Procedure: non positive pressure mechanical ventilatory support

• Registration Number: NCT00925860
• Lead Sponsor: Hospital Provincial de Castellon

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 Timeline

• Study Start: 2001-06
• Primary Completion: 2006-06
• Study Completion: 2007-06
• Status Verified: 2009-06
• Study First Submitted: 2009-06-19
• Study First Submitted QC: 2009-06-19
• Last Update Submitted: 2009-06-19
• Study First Posted: 2009-06-22
• Last Update Posted: 2009-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non invasive ventilation approach	non positive pressure mechanical ventilatory support	pure hypoxemic patients admitted to ICU treated by non-positive pressure mechanical ventilation

Primary Outcome Measures

Name	Time	Method
mortality rates	patient hospital discharge

Secondary Outcome Measures

Name	Time	Method
oxygenation improve	patient hospital discharge
diminishing of tracheal intubation incidence	patient hospital discharge
ICU and Post ICU hospital length of stay	patient hospital discharge

Trial Locations

Locations (1)

Intensive Care Department - General Hospital; 🇪🇸 Castello, Spain