CPAP improves oxigenation after cardiac surgery

CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS Trial). A randomized controlled trial - CRHACS

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002672-13-IT

Enrollment

960

Registered

2021-06-08

Start date

2021-03-18

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemia after cardiac surgery MedDRA version: 20.0 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Ossigeno Product Code: [A039110061] Pharmaceutical Form: Medicinal gas, compressed CAS Number: 7782-44-7 Current Sponsor code: Oxygen Other descriptive name: Oxygen Concentration unit: %

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patients undergoing cardiac surgery on cardiopulmonary bypass - PaO2/FiO2 =65 years) yes F.1.3.1 Number of subjects for this age range 320

Exclusion criteria

Exclusion criteria: - patients < 18 years old - extracorporeal membrane oxygenation - severe cardiac dysfunction (FE<25%) - mechanical ventilation before the intervention - severe COPD (patients on oxygen therapy, with a FEV1< 50%) - heart or lung transplantation - lack of consent.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To test the hypothesis that the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.;Primary end point(s): Rate of re-intubation.;Timepoint(s) of evaluation of this end point: 72 h;Main Objective: To test the hypothesis that the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.	—

Measure

Time frame

Secondary Objective: To test the hypothesis that the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.;Primary end point(s): Rate of re-intubation.;Timepoint(s) of evaluation of this end point: 72 h;Main Objective: To test the hypothesis that the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.

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Secondary

Measure	Time frame
Secondary end point(s): Incidence of atelectasis, pneumonia, sepsis, the mortality rate, the intensive care unit (ICU) and hospital length of stay;Timepoint(s) of evaluation of this end point: Up to 30 days	—

Countries

Italy

Contacts

Public ContactDipartimento di Scienze Mediche e C

Alma Mater Studiorum Università di Bologna

m.ranieri@unibo.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026