E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Severe acute respiratory failure |
Insuficiencia respiratoria aguda severa |
|
E.1.1.1 | Medical condition in easily understood language |
Severe acute respiratory failure |
Insuficiencia respiratoria aguda severa |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
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 |
1. To Evaluate if the high flow oxigen therapy with warm system of humidificación by means of nasal glasses (optiflow) opposite to the conventional oxygen therapy like treatment of the severe acute respiratory failure of any etiology determines a minor need of intubation orotraqueal. 2. To evaluate if the system optiflow provides a better tolerance and comfort of the patient with severe acute respiratory failure that needs oxygen therapy to high concentrations of oxygen. |
1.Evaluar si la oxigenoterapia de alto flujo con sistema caliente de humidificación mediante gafas nasales (optiflow) frente a la oxigenoterapia convencional como tratamiento de la insuficiencia respiratoria aguda severa de cualquier etiología condiciona una menor necesidad de intubación orotraqueal.
2.Evaluar si el sistema optiflow proporciona una mejor tolerancia y confort del paciente con insuficiencia respiratoria severa que requiere oxigenoterapia a altas concentraciones de oxígeno. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate if there exist variables of the clinical initial situation and of the clinical evolution and / or gasométrica of the first 24 hours after the recruitment, which they could endure as predictive factors of intubation orotraqueal in these patients. |
Evaluar si existen variables de la situación clínica inicial y de la evolución clínica y/o gasométrica de las primeras 24 horas tras el reclutamiento, que puedan comportarse como factores predictivos de intubación orotraqueal en estos pacientes. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
?Patients of both major sexes of 18 years joined UCI. ?severe acute respiratory failure defined clinical for: peripheral Saturation of oxygen (SatO2p by means of pulsioximetria) <94 % respiratory superior Frequency to 30 r/min during 30 minutes with mask of venturi to 60 %, with or without pulmonary infiltrators in X-ray photography of thorax. |
?Pacientes de ambos sexos mayores de 18 años ingresados en UCI.
?Insuficiencia respiratoria aguda definida clínicamente por:
Saturación de oxígeno periférica (SatO2p mediante pulsioximetria) < 94%
Frecuencia respiratoria superior a 30 r/min durante 30 minutos con mascarilla de venturi al 60%, con o sin infiltrados pulmonares en radiografía de tórax. |
|
E.4 | Principal exclusion criteria |
?Glasgow <11 ? Need of urgent intubation ?sharp Agitation without collaboration of the patient ? Shock with instability hemodinámica that does not answer to volume and aminas vasoactivas. ? Any patient who to criterion of the investigator could not expire with the specifications of the protocol |
?Deformidad anatómica que impida la ventilación por gafas nasales
?Glasgow <11
?Necesidad de intubación urgente
?Agitación aguda sin colaboración del paciente
?Shock con inestabilidad hemodinámica que no responda a volumen y aminas vasoactivas.
?Cualquier paciente que a criterio del investigador no pueda cumplir con las especificaciones del protocolo |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1.Need of intubation orotraqueal
2. Tolerance and comfort on the utilization of the devices of oxygen therapy. |
1. Necesidad de intubación orotraqueal
2. Tolerancia y confort sobre la utilización de los dispositivos de oxigenoterapia. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Need of intubation orotraqueal (hours up to the intubation, days of intubation),Parameters: ' Respiratory (respiratory frequency, SatO2p), ' Gasométricos (pH, pO2, pCO2 and balance acid - base)
Tolerance and comfort on the utilization of the devices of oxygen therapy |
Necesidad de intubación orotraqueal (horas hasta la intubación, días de intubación). Parámetros:Respiratorios (frecuencia respiratoria, SatO2p), Gasométricos (pH, pO2, pCO2 y equilibrio ácido-base)
tolerancia y confort sobre la utilización de los dispositivos de oxigenoterapia |
|
E.5.2 | Secondary end point(s) |
Exitus, Infection nosocomial, Pneumonia, days of stay in UCI and in the hospital |
Exitus , Infección nosocomial, Neumonía, días de estancia en UCI y en el hospital |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
exitus, Infection nosocomial, Pneumonia, days of stay in UCI and in the hospital |
exitus , Infección nosocomial, Neumonía, días de estancia en UCI y en el hospital |
|
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Oxigenoterapia convencional con mascarilla tipo venturi |
Conventional oxigen therapy with a venturi mask |
|
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
|
on which the last subject completed the study treatment during his stay in the UCI |
Fecha en la que el último sujeto completa el tratamiento durante su ingreso en la Unidad de cuidados intensivos |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |