Efects of Noninvasive Mechanical Ventilation and Conventional Mechanical Ventilation in Patients With Severe Comunity Pneumonia - Full Text View

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. )

Sponsored by:	Hospital Privado del Sur
Information provided by:	Hospital Privado del Sur
ClinicalTrials.gov Identifier:	NCT00523497

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

MedlinePlus related topics:

Pneumonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

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

Locations


Argentina, Buenos Aires
	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	Unaffiliated

More Information

Study ID Numbers:	NIV67-07
First Received:	August 30, 2007
Last Updated:	August 30, 2007
ClinicalTrials.gov Identifier:	NCT00523497
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.

Study placed in the following topic categories:

Respiratory Insufficiency

Respiratory Tract Infections

Respiratory Tract Diseases

Lung Diseases

Respiration Disorders

Pneumonia

ClinicalTrials.gov processed this record on October 10, 2008