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Non Invasive Ventilation After Cardiac Surgery (CPAP-CCH)

This study is currently recruiting participants.
Verified December 2012 by Università Vita-Salute San Raffaele
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT01249794
First received: November 29, 2010
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

Patients with respiratory failure following cardiac surgery are randomized to receive standard therapy versus non invasive ventilation. The hypothesis is that patients receiving non invasive ventilation will perform better than those who received standard therapy.


Condition Intervention
Respiratory Failure.
 Procedure: non invasive ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Continuous Positive Airway Pressure Outside the Intensive Care Unit After Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Università Vita-Salute San Raffaele:

Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Best available treatment
Experimental: non invasive ventilation Procedure: non invasive ventilation
continuous positive airways pressure
Other Names:
  • NIV
  • CPAP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hypoxia

Exclusion Criteria:

  • pneumothorax
  • cardiocirculatory instability
  • no written consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249794

Contacts
Contact: giovanni landoni, MD landoni.giovanni@hsr.it
Contact: luigi olper, PT luigi.olper@tin.it

Locations
Italy
Ospedale San Raffaele di Milano, Italy Recruiting
Milano, Italy, 20132
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
Principal Investigator: Ottavio Alfieri, MD Vita-Salute San Raffaele, Milano, Italia
  More Information

No publications provided

Responsible Party: Giovanni Landoni, MD, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT01249794     History of Changes
Other Study ID Numbers: GO/URC/ER/mm 183/DG
Study First Received: November 29, 2010
Last Updated: December 11, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Università Vita-Salute San Raffaele:
NIV
non invasive ventilation
cardiac surgery
continuous positive airway pressure

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013