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Non-Positive Pressure Ventilation in Hypoxemic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00925860
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : June 22, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Procedure: non positive pressure mechanical ventilatory support Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Positive Pressure Ventilation in Hypoxemic Patients. A Randomized Study
Study Start Date : June 2001
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2007

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

Primary Outcome Measures :
  1. mortality rates [ Time Frame: patient hospital discharge ]

Secondary Outcome Measures :
  1. oxygenation improve [ Time Frame: patient hospital discharge ]
  2. diminishing of tracheal intubation incidence [ Time Frame: patient hospital discharge ]
  3. ICU and Post ICU hospital length of stay [ Time Frame: patient hospital discharge ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00925860

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Intensive Care Department - General Hospital
Castello, Spain, 12004
Sponsors and Collaborators
Hospital Provincial de Castellon
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Layout table for additonal information Identifier: NCT00925860     History of Changes
Other Study ID Numbers: HGCS-2009-1
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: June 22, 2009
Last Verified: June 2009
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases