Efects of Noninvasive Mechanical Ventilation and Conventional Mechanical Ventilation in Patients With Severe Comunity Pneumonia (NIMV AND SCAP)

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: NCT00523497
Recruitment Status : Terminated (Interim analysis of the present study showed a significant decrease in mortality rate (p= 0.04) as well as in the number of days at the ICU p=0.0002.)
First Posted : August 31, 2007
Last Update Posted : August 31, 2007
Information provided by:
Hospital Privado del Sur

Brief Summary:
The purpose of this study is to determine whether the noninvasive ventilation is more effective in the treatment of severe comunity acquired pneumonia in comparison with the conventional mechanical ventilation with orotracheal intubation.

Condition or disease Intervention/treatment Phase
Community Acquired Pneumonia. Acute Hypoxemic Respiratory Failure Device: Non invasive mechanical ventilation Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Noninvasive Mechanical Ventilation in Severe Community-Acquired Pneumonia and Acute Hypoxemic Respiratory Failure. A Prospective, Randomized and Controlled Study

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The primary aim of this study was to compare the effects of NIMV on mortality rate and length of stay at the ICU with the effects of CMV [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. The secondary aims were to evaluate the incidence and the complications of OTI as well as to compare the improvements in the gas exchange. [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

The criteria for the diagnosis of SCAP included:

  • Blood systolic pressure lower than 90 mmHg or blood diastolic pressure lower than 60 mmHg
  • RR higher than 30 breaths per minute
  • PaO2/FiO2 lower than 250 while breathing through a Venturi mask with a 50% inspired oxygen fraction (FiO2)
  • Bilateral or multiple lobar infiltrations evidenced by thorax X-ray, and
  • Use of vasopressor drugs

Exclusion Criteria:

Exclusion criteria included:

  • COPD
  • Asthma
  • Acute cardiogenic pulmonary edema
  • Severe haemodynamic instability (arterial systolic pressure lower than 70 mmHg) or requirements of vasoactive drugs
  • Glasgow score equal to or lower than 9 or requiring OTI for airway protection or for recent pulmonary resucitation
  • Antecedents of respiratory failure resulting from neuromuscular pathology
  • Failure of two or more organs
  • Facial deformities; and
  • Recent facial, aesophagic and gastric surgeries

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): NCT00523497

Hospital Privado del Sur
Bahía Blanca, Buenos Aires, Argentina, 8000
Sponsors and Collaborators
Hospital Privado del Sur
Principal Investigator: S. A Lasdica, Study Principal Investigator Identifier: NCT00523497     History of Changes
Other Study ID Numbers: NIV67-07
First Posted: August 31, 2007    Key Record Dates
Last Update Posted: August 31, 2007
Last Verified: August 2007

Keywords provided by Hospital Privado del Sur:
Severe community-acquired pneumonia
Noninvasive mechanical ventilation
Acute hypoxemic respiratory failure.

Additional relevant MeSH terms:
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders