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Clinical Trials/NCT00523497
NCT00523497TerminatedNot Applicable

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

Hospital Privado del Sur2 sites in 1 countryStarted: August 31, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Locations
2
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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:
  • •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

Outcomes

Primary Outcomes

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 Outcomes

  • The secondary aims were to evaluate the incidence and the complications of OTI as well as to compare the improvements in the gas exchange.(3 years)

Investigators

Sponsor Class
Other

Study Sites (2)

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