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Reduction of interest and recruitment.
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| Name | Class |
|---|---|
| Agenzia Italiana del Farmaco | OTHER_GOV |
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The aim of study is to evaluate whether the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.
We want 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: to reduce the rate of re-intubation.
Secondary end point: to reduce the incidence of atelectasis, pneumonia, sepsis, the mortality rate, the intensive care unit (ICU) and hospital length of stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TREATMENT | Experimental | Helmet CPAP |
|
| CONTROL | Active Comparator | Venturi Mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helmet CPAP | Procedure | the patient will receive CPAP treatment, at a PEEP level of 10 cmH2O and a FiO2 adjusted to maintain SpO2>95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will repeat a spontaneous breathing trial with a Venturi mask at FiO2 = 50%, for 15 minutes and than a blood gas analysis will be repeated: if the PaO2/FiO2 will be < 200 the patient will received a second treatment with CPAP; if PaO2/FiO2 will be >200, the patient will stop the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| rate of re-intubation | at 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of atelectasis | at 28 days | |
| incidence of pneumonia | at 28 days | |
| incidence of sepsis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vito Marco VM Ranieri, MD | University of Turin, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Turin - Department of Anesthesia and Intensive Care Medicine | Turin | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40574561 | Derived | Pasero D, Costamagna A, Filippini C, Blangetti I, Cattaneo S, Baiocchi M, Balata A, Bottiroli M, Dambruoso P, De Paulis S, Grazioli L, Locatelli A, Lorini FL, Mascotti A, Mondino MG, Paparella D, Salvi L, Tonetti T, Tritapepe L, Ranieri VM. Continuous positive airway pressure to prevent reintubation in patients recovering from cardiac surgery: A multicentre randomised clinical trial. Eur J Anaesthesiol. 2025 Nov 1;42(11):958-965. doi: 10.1097/EJA.0000000000002229. Epub 2025 Jun 27. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| Venturi Mask | Procedure | the patient will maintain spontaneous breathing, with a system for oxygen delivery at a FiO2 adjusted to maintain SpO2>95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will do a trial for 15 minutes and after that a blood gas analysis will be repeated: if the PaO2/FiO2 will be < 200 the patient will go on with the control treatment; if PaO2 /FiO2 will be >200, the patient will stop the treatment. |
|
| at 28 days |
| mortality rate | at 28 days |
| the intensive care unit length of stay | at 28 days |
| hospital length of stay | at 28 days |