E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypoxemia after cardiac surgery |
Ipossiemia dopo chirurgia cardiaca |
|
E.1.1.1 | Medical condition in easily understood language |
Reduction of blood oxygen levels after cardiac surgery |
Riduzione dei livelli di ossigeno nel sangue dopo chirurgia cardiaca |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10038738 |
E.1.2 | Term | Respiratory, thoracic and mediastinal disorders |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Testare l'ipotesi che l'applicazione di una pressione positiva continua a livello delle vie aeree (CPAP) dopo l'estubazione nei pazienti sottoposti a chirurgia cardiaca possa ridurre l'ipossiemia e la percentuale di re-intubazione. |
|
E.2.2 | Secondary objectives of the trial |
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. |
Testare l'ipotesi che l'applicazione di una pressione positiva continua a livello delle vie aeree (CPAP) dopo l'estubazione nei pazienti sottoposti a chirurgia cardiaca possa ridurre l'ipossiemia e la percentuale di re-intubazione. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- patients undergoing cardiac surgery on cardiopulmonary bypass - PaO2/FiO2 < 200 after extubation - extubation time < 24 h. |
- pazienti sottoposti a chirurgia cardiaca in circolazione extra- corporea
- rapporto PaO2/FiO2 < 200 dopo estubazione
- tempo di estubazione < 24 ore |
|
E.4 | Principal 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. |
pazienti con eta` inferiore a 18 anni
assistenza circolatoria extracorporea (ECMO)
scompenso cardiaco grave (FE < 25%)
ventilazione meccanica pre-intervento
BPCO grave (pazienti in ossigenoterapia, con una FEV1 <50%)
trapianto dicuore o polmone
mancanza di consenso informato |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Rate of re-intubation. |
Percentuale di re-intubazione. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Incidence of atelectasis, pneumonia, sepsis, the mortality rate, the intensive care unit (ICU) and hospital length of stay |
Incidenza di atelectasie, polmonite, sepsi, la mortalita` e la degenza in terapia intensive ed ospedaliera. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to 30 days |
Fino a 30 giorni |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
ossigenoterapia convenzionale |
conventional oxygen therapy |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |