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

This study has been 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.)
Sponsor:
Information provided by:
Hospital Privado del Sur
ClinicalTrials.gov Identifier:
NCT00523497
First received: August 30, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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 Intervention
Community Acquired Pneumonia.
Acute Hypoxemic Respiratory Failure
Device: Non invasive mechanical ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 NLM:


Further study details as provided by Hospital Privado del Sur:

Primary Outcome Measures:
  • 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:
  • 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 ]

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523497

Locations
Argentina
Hospital Privado del Sur
Bahía Blanca, Buenos Aires, Argentina, 8000
Sponsors and Collaborators
Hospital Privado del Sur
Investigators
Principal Investigator: S. A Lasdica, Study Principal Investigator
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00523497     History of Changes
Other Study ID Numbers: NIV67-07
Study First Received: August 30, 2007
Last Updated: August 30, 2007
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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

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

ClinicalTrials.gov processed this record on July 22, 2014