Efects of Noninvasive Mechanical Ventilation and Conventional Mechanical Ventilation in Patients With Severe Comunity Pneumonia

Acute Hypoxemic Respiratory Failure Clinical Trial

— NIMV AND SCAP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00523497
• Other study ID #: NIV67-07
• Status: Terminated
• Phase: N/A
• First received: August 30, 2007
• Last updated: August 30, 2007

Study information

• Verified date: August 2007
• Source: Hospital Privado del Sur
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Community Acquired Pneumonia.
• Pneumonia
• Respiratory Insufficiency

Intervention

Device:
• Non invasive mechanical ventilation

Locations

Country	Name	City	State
Argentina	Hospital Privado del Sur	Bahía Blanca	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Privado del Sur

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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