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Non-Positive Pressure Ventilation in Hypoxemic Patients

This study has been completed.
Sponsor:
Information provided by:
Hospital General De Castellon
ClinicalTrials.gov Identifier:
NCT00925860
First received: June 19, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Failure
 Procedure: non positive pressure mechanical ventilatory support
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-Positive Pressure Ventilation in Hypoxemic Patients. A Randomized Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital General De Castellon:

Primary Outcome Measures:
  • mortality rates [ Time Frame: patient hospital discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • oxygenation improve [ Time Frame: patient hospital discharge ] [ Designated as safety issue: No ]
  • diminishing of tracheal intubation incidence [ Time Frame: patient hospital discharge ] [ Designated as safety issue: No ]
  • ICU and Post ICU hospital length of stay [ Time Frame: patient hospital discharge ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: June 2001
Study Completion Date: June 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925860

Locations
Spain
Intensive Care Department - General Hospital
Castello, Spain, 12004
Sponsors and Collaborators
Hospital General De Castellon
Investigators
Principal Investigator: Alberto Belenguer, MD INTENSIVE CARE DEPARTMENT, HOSPITAL GENERAL DE CASTELLO
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00925860     History of Changes
Other Study ID Numbers: HGCS-2009-1
Study First Received: June 19, 2009
Last Updated: June 19, 2009
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on May 21, 2013