NCT01249794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

3.3 years

First QC Date

November 29, 2010

Last Update Submit

March 20, 2018

Conditions

Respiratory Failure

Keywords

NIVnon invasive ventilationcardiac surgerycontinuous positive airway pressure

Study Arms (2)

Best available treatment

NO INTERVENTION

non invasive ventilation

EXPERIMENTAL
Procedure: non invasive ventilation

Interventions

non invasive ventilationPROCEDURE

continuous positive airways pressure

Also known as: NIV, CPAP
non invasive ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hypoxia

You may not qualify if:

  • pneumothorax
  • cardiocirculatory instability
  • no written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Raffaele di Milano, Italy

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Ottavio Alfieri, MD

    Vita-Salute San Raffaele, Milano, Italia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 29, 2010

First Posted

November 30, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

IT(1)