E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
postoperative atelectasis / pneumonias |
Atelectasias/neumonias postoperatorias |
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E.1.1.1 | Medical condition in easily understood language |
postoperative respiratory complications |
complicaciones respiratorias postoperatorias |
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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 | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069454 |
E.1.2 | Term | Partial atelectasis |
E.1.2 | System Organ Class | 100000004855 |
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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 compare the effects of CPAP at 5-7 cmH2O vs standard treatment on the frequency of atelectasis/pneumonia, as determined by clinical and radiographic criteria, in patients undergoing Lung resection surgery and no more than 4 hours of postoperative mechanical ventilation. |
Evaluar mediante radiografía de tórax y criterios clínicos la frecuencia de neumonía o atelectasias en la primera semana postoperatoria en pacientes que no hayan sufrido más de 4 h de ventilación mecánica tras ser operados con CPAP 5-7 cmH2O o tratamiento estándar. |
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E.2.2 | Secondary objectives of the trial |
1)compare the frequencies of patients with a PaO2/FiO2 <300 with CPAP at 5-7 cmH2O vs standard treatment the morning following the surgical procedure on patients .2) compare the frequencies of patients presenting persistent air leak with CPAP at 7 cmH2O vs standard treatment on patients .3)To compare the frequencies of patients presenting any pulmonary or cardiac complications with CPAP at 5-7 cmH2O vs standard treatment.4) compare the effects of CPAP at 5-7 cmH2O vs standard treatment in the hospital stay from the day of surgery until hospital discharge on patients.5)compare frecuency of patients on CPAP at 5-7 cmH2O group vs standard treatment staying more than one day in the postanesthesic care unit. |
1) Comparar la proporción de pacientes que presenten una PaO2/FiO2<300 en la gasometría obtenida la mañana siguiente de la cirugía en los grupos CPAP 5-7cmH2O o tratamiento estándar.2) Comparar la frecuencia de pacientes con fuga aérea persistente en los grupos CPAP 5-7cmH2O o tratamiento estándar.3) Comparar la tasa global de complicaciones entre los en los grupos CPAP 5-7cmH2O o tratamiento estándar.4) Comparar entre los pacientes de ambos grupos, la estancia desde el día de la cirugía hasta su alta .5) Comparar en los pacientes de ambos grupos desde el día de ingreso hasta su alta la proporción de pacientes de cada grupo que sufran más de un día de ingreso en URPA o REA |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1)Being over 18 and ethically competent. 2)Undergo any thoracic surgery including resection of lung parenchyma and carriers of thoracic epidural or paravertebral catheter for perioperative thoracic analgesia. 3)To have given written consent to enter this study. |
3)Ser mayor de 18 años y éticamente competente. 2)Ser sometidos a cualquier cirugía torácica que incluya resección del parénquima pulmonar y ser portadores de catéter epidural o paravertebral torácicos para el manejo perioperatorio de la analgesia torácica. 3)Haber dado el consentimiento para entrar en este estudio. |
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E.4 | Principal exclusion criteria |
1)Patients who have not been extubated in the first 4 h post surgery. 2)Patients with suspected bronchopleural fistula at PCU admission . 3)Patients with facial problems or patients with a history of intolerance to CPAP masks. 4)Having significant bullous emphysema. 5)Patients having Obstructive apnea syndrome and have been recomended of any kind of noninvasive ventilation. 6)Patients who have consumed at least one month before surgery potential immunosuppressive drugs (except corticosteroids administered by inhalation). |
1)pacientes que no hayan podido ser o extubados en las primeras 4h. 2)pacientes con sospecha de fístula broncopleural al ingreso en la URPA. 3)Pacientes con problemas faciales o antecedentes de intolerancia a mascarillas de CPAP 4)tener enfisema bulloso significativo definido como la presencia de más de 5 bullas contiguas <2cm o la existencia de una bulla pulmonar >2 cm o distrofia bullosa, que no estén en la zona a resecar y haber tenido un neumotórax previo. 5)Presencia de SAOS en los que se haya recomendado alguna forma de ventilación mecánica no invasiva. 6)Pacientes que hayan consumido en al menos un mes antes de la cirugía fármacos con potencial inmunosupresor (excepto corticoides administrados por vía inhalatoria). |
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E.5 End points |
E.5.1 | Primary end point(s) |
the frequency of atelectasis/pneumonia by the intervention (CPAP at 5-7 cmH2O, 6h) vs the active comparator(standard treatment), as determined by clinical and radiographic criteria, in patients undergoing lung resection surgery and no more than 4 h of postoperative mechanical ventilation. |
frecuencia de atelectasias/pneumonía debida a la intervención (CPAP at 5-7 cmH2O, 6h) frente al comparador active (tratamiento estándar) determinado por criterios clínicos y radiográficos en pacientes operados de cirugía con resección pulmonar que hayan sido extubados en menos de 4h tras la cirugía. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 hours after extubation |
a las 24 horas tras la extubación E.5.2 |
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E.5.2 | Secondary end point(s) |
treatment, as determined by arterial blood gas analysis and the FiO2 supplied by the Ventura mask.2)significative difference betweene frequencies of patients with a PaO2/FiO2 <300 with CPAP at 5-7 cmH2O vs standard treatment the morning following the surgical procedure .3)A difference of a day hospital stay from the day of surgery until discharge between the two groups. 4) Compare the proportion of patients requiring more than one day of admission at PACU between two groups . 5)Frequencies of patients presenting persistent air leak in the two groups.6)Frequencies of patients presenting any pulmonary or cardiac complications . |
1)Una diferencia de 30 puntos de mejoría en el intercambio gaseoso debidos a la intervención (CPAP a 5-7 cmH2O, 6h) frente al tratamiento estándar determinados mediante gasometría arterial, y FiO2 proporcionado por la mascarilla Ventimask.2)Una diferencia significativa en la proporción de pacientes con PaO2/FiO2 <300 con CPAP a 5-7 cmH2O versus tratamiento estándar a la mañana siguiente de la intervención.3)Una diferencia de un día en la estancia hospitalaria desde el día de la cirugía hasta el alta entre los dos grupos.4)Comparar entre ambos grupos la proporción de pacientes que requiere más de un día de ingreso en URPA o REA.5)Comparar la frecuencia de pacientes con fuga aérea persistente entre los dos grupos. 6)Comparar la frecuencia de pacientes que presentan cualquier complicación pulmonar o cardiaca |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 24 hours after extubation 2) the morning following the surgical procedure 3)at hospital discharge or exitus 4) at PACU or discharge(or exitus in PACU) 5)at hospital discharge 6) 30 days after surgery |
1) a las 24 horas tras la extubación 2)a la mañana siguiente de la intervención quirúrgica 3)al alta hospitalaria o fallecimiento 4) al alta de la REA o URPA(o fallecimiento en URPA o REA) 5)al alta 6) 30 días siguientes a la intervencion |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
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 |
tratamiento estandar |
standard treatment |
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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 | 4 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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Last patient lasta visit |
ultima visita ultimo paciente |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |