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

August 30, 2007 updated by: Hospital Privado del Sur

Noninvasive Mechanical Ventilation in Severe Community-Acquired Pneumonia and Acute Hypoxemic Respiratory Failure. A Prospective, Randomized and Controlled Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Bahía Blanca, Buenos Aires, Argentina, 8000
        • Hospital Privado del Sur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Privado del Sur

Investigators

  • Principal Investigator: S. A Lasdica, Study Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 30, 2007

First Submitted That Met QC Criteria

August 30, 2007

First Posted (Estimate)

August 31, 2007

Study Record Updates

Last Update Posted (Estimate)

August 31, 2007

Last Update Submitted That Met QC Criteria

August 30, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIV67-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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