NCT00523497

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
Last Updated

August 31, 2007

Status Verified

August 1, 2007

First QC Date

August 30, 2007

Last Update Submit

August 30, 2007

Conditions

Community Acquired Pneumonia.Acute Hypoxemic Respiratory Failure

Keywords

Severe community-acquired pneumoniaNoninvasive mechanical ventilationAcute hypoxemic respiratory failure.

Outcome Measures

Primary Outcomes (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

    3 years

Secondary Outcomes (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.

    3 years

Interventions

Non invasive mechanical ventilationDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Privado del Sur

Bahía Blanca, Buenos Aires, 8000, Argentina

Location

MeSH Terms

Conditions

Community-Acquired PneumoniaRespiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • S. A Lasdica, Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2007

First Posted

August 31, 2007

Last Updated

August 31, 2007

Record last verified: 2007-08

Locations

AR(1)