Non-Positive Pressure Ventilation in Hypoxemic Patients

NCT ID: NCT00925860

Last Updated: 2009-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30
• Study Completion Date: 2007-06-30

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.

Conditions

Acute Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

non invasive ventilation approach

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

Group Type: EXPERIMENTAL

non positive pressure mechanical ventilatory support

Intervention Type: PROCEDURE

conventionally ventilated

pure hypoxemic patients treated by conventional ventilatory support

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

non positive pressure mechanical ventilatory support

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Provincial de Castellon

OTHER

Sponsor Role: lead

Principal Investigators

Alberto Belenguer, MD

Role: PRINCIPAL_INVESTIGATOR

INTENSIVE CARE DEPARTMENT, HOSPITAL GENERAL DE CASTELLO

Locations

Intensive Care Department - General Hospital

Castelló, CASTELLO, Spain

Countries

Spain

Other Identifiers

HGCS-2009-1

Identifier Type: -

Identifier Source: org_study_id