- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00523497
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
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
-
-
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
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.
Clinical Trials on Acute Hypoxemic Respiratory Failure
-
Beijing Chao Yang HospitalRecruitingPatients With Acute Hypoxemic Respiratory FailureChina
-
Dr. Behcet Uz Children's HospitalCompletedAcute Respiratory Failure | Acute Hypoxemic Respiratory Failure | Acute Hypoxemic and Hypercapnic Respiratory FailureTurkey
-
Yonsei UniversityNot yet recruitingRespiratory Failure | Respiratory Insufficiency | Hypercapnic Respiratory Failure | Acute Hypoxemic Respiratory Failure | Acute Hypercapnic Respiratory Failure | Ventilatory Depression | Hypoxemic Respiratory Failure | Respiratory Depression | Hypoxemic Acute Respiratory Failure | Hypercapnic AcuteKorea, Republic of
-
Hospital General Universitario Morales MeseguerNot yet recruitingEvaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure
-
Niguarda HospitalRecruitingPneumonia-associated Acute Hypoxemic Respiratory FailureItaly
-
Poitiers University HospitalRecruitingAcute Respiratory Failure | Hypoxemic Respiratory FailureFrance
-
Nantes University HospitalCompletedHypoxemic Acute Respiratory FailureFrance
-
Sunnybrook Health Sciences CentreRecruitingAcute Hypoxemic Respiratory FailureCanada
-
Siriraj HospitalRecruitingAcute Hypoxemic Respiratory Failure | Acute Hypercapnic Respiratory FailureThailand
-
Fisher and Paykel HealthcareCentre hospitalier de l'Université de Montréal (CHUM); Institut universitaire...Not yet recruitingAcute Hypoxemic Respiratory Failure | Acute Hypercapnic Respiratory Failure
Clinical Trials on Non invasive mechanical ventilation
-
Centre Hospitalier Universitaire de Saint EtienneTerminatedChronic Obstructive Pulmonary Disease With Acute Exacerbation, UnspecifiedFrance
-
Karolinska InstitutetCompleted
-
Centre d'Investigation Clinique et Technologique...UnknownNeuromuscular DiseaseFrance
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR)TerminatedChronic Obstructive Pulmonary DiseaseCanada
-
Swedish Intensive Care RegistryCompletedCritical Care | Chronic Obstructive Airways Disease ExacerbatedSweden
-
Montefiore Medical CenterRecruiting
-
Hospital Clinic of BarcelonaHospital Universitari Vall d'Hebron Research Institute; Fundació Institut de...CompletedChronic Respiratory Failure
-
Peking Union Medical College HospitalThe First Affiliated Hospital with Nanjing Medical University; National Natural... and other collaboratorsUnknownAcute Respiratory Failure | Immunocompromised Patients
-
Assiut UniversityUnknownMechanical Ventilation Complication
-
University Hospital, CaenCompletedChronic Obstructive Pulmonary Disease (COPD) | Decompensated COPD With (Acute) ExacerbationFrance