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Non Invasive Ventilation After Cardiac Surgery (CPAP-CCH)

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
non invasive ventilation
Sponsored by
Università Vita-Salute San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring NIV, non invasive ventilation, cardiac surgery, continuous positive airway pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hypoxia

Exclusion Criteria:

  • pneumothorax
  • cardiocirculatory instability
  • no written consent

Sites / Locations

  • Ospedale San Raffaele di Milano, Italy

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Best available treatment

non invasive ventilation

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 29, 2010
Last Updated
March 20, 2018
Sponsor
Università Vita-Salute San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT01249794
Brief Title
Non Invasive Ventilation After Cardiac Surgery
Acronym
CPAP-CCH
Official Title
Effectiveness of Continuous Positive Airway Pressure Outside the Intensive Care Unit After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università Vita-Salute San Raffaele

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
NIV, non invasive ventilation, cardiac surgery, continuous positive airway pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
Best available treatment
Arm Type
No Intervention
Arm Title
non invasive ventilation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
non invasive ventilation
Other Intervention Name(s)
NIV, CPAP
Intervention Description
continuous positive airways pressure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: hypoxia Exclusion Criteria: pneumothorax cardiocirculatory instability no written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ottavio Alfieri, MD
Organizational Affiliation
Vita-Salute San Raffaele, Milano, Italia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale San Raffaele di Milano, Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

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Non Invasive Ventilation After Cardiac Surgery

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