Non Invasive Ventilation After Cardiac Surgery (CPAP-CCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01249794
Recruitment Status : Completed
First Posted : November 30, 2010
Last Update Posted : March 22, 2018
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele

Brief Summary:
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 or disease Intervention/treatment Phase
Respiratory Failure Procedure: non invasive ventilation Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Continuous Positive Airway Pressure Outside the Intensive Care Unit After Cardiac Surgery
Study Start Date : September 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Best available treatment
Experimental: non invasive ventilation Procedure: non invasive ventilation
continuous positive airways pressure
Other Names:
  • NIV
  • CPAP

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • hypoxia

Exclusion Criteria:

  • pneumothorax
  • cardiocirculatory instability
  • no written consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01249794

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

Responsible Party: Giovanni Landoni, MD, Università Vita-Salute San Raffaele Identifier: NCT01249794     History of Changes
Other Study ID Numbers: GO/URC/ER/mm 183/DG
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

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

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