Non-Positive Pressure Ventilation in Hypoxemic Patients

Non-Positive Pressure Ventilation in Hypoxemic Patients. A Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Procedure: non positive pressure mechanical ventilatory support

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Castello, Spain, 12004
    • Intensive Care Department - General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: non invasive ventilation approach; pure hypoxemic patients admitted to ICU treated by non-positive pressure mechanical ventilation	Procedure: non positive pressure mechanical ventilatory support
No Intervention: conventionally ventilated; pure hypoxemic patients treated by conventional ventilatory support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mortality rates	patient hospital discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
oxygenation improve	patient hospital discharge
diminishing of tracheal intubation incidence	patient hospital discharge
ICU and Post ICU hospital length of stay	patient hospital discharge

Collaborators and Investigators

• Sponsor: Hospital Provincial de Castellon
• Investigators: Principal Investigator: Alberto Belenguer, MD, INTENSIVE CARE DEPARTMENT, HOSPITAL GENERAL DE CASTELLO

Study record dates

Study Major Dates

• Study Start: June 1, 2001
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: June 19, 2009
• First Submitted That Met QC Criteria: June 19, 2009
• First Posted (Estimate): June 22, 2009

Study Record Updates

• Last Update Posted (Estimate): June 22, 2009
• Last Update Submitted That Met QC Criteria: June 19, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: HGCS-2009-1