Non Invasive Ventilation After Cardiac Surgery (CPAP-CCH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giovanni Landoni, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT01249794
First received: November 29, 2010
Last updated: October 13, 2015
Last verified: October 2015
  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:


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

Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: December 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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hypoxia

Exclusion Criteria:

  • pneumothorax
  • cardiocirculatory instability
  • no written consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249794

Locations
Italy
Ospedale San Raffaele di Milano, Italy
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

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: October 13, 2015
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 July 28, 2016