Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Acute Exacerbation of Respiratory Failure
Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Acute Exacerbation of Chronic Respiratory Failure
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients admitted to hospital with acute exacerbation of chronic respiratory failure.
The investigators hypothesise that autotitrating NIV will ventilate patients with acute exacerbations of chronic respiratory failure as effectively as standard NIV.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients admitted to hospital with a sudden worsening of their existing breathing insufficiency, including an increase of carbon dioxide in the blood (hypercapnia) and acidity of the blood. Noninvasive ventilation (NIV) is standard therapy for patients with acute hypercapnic exacerbations (sudden worsening of existing breathing insufficiency) of both chronic obstructive pulmonary disease (COPD) and nonCOPD patients.
The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.
Patients over the age of 18 admitted to Royal Brompton Hospital respiratory ward will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. After 24 hours on the first NIV the patient will be swapped to the alternative NIV for a further 24 hours of treatment.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
London, Reino Unido, SW3 6NP
- Royal Brompton Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- patients admitted or transferred to Royal Brompton Hospital with acute exacerbation of chronic respiratory failure, or inpatients who suffer a deterioration in respiratory status, defined as 7.25 < pH < 7.35, PaCO2 > 6.0kPa, and respiratory rate > 20bpm
Exclusion Criteria:
- < 18 years old
- pH < 7.25
- need for immediate intubation
- uncontrolled cardiac failure
- hypotensive (systolic blood pressure < 90mmHg)
- acute myocardial infarction
- acute dysrhythmia
- other system failure (e.g. acute renal failure, liver failure)
- moderate or severe bulbar weakness
- inability to understand rationale and/or consent form for study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: autotitrating NIV
approximately 24 hours using autotitrating non-invasive ventilation for as many hours as possible whilst an inpatient in hospital
|
Automatically titrated non-invasive ventilator, with target gross alveolar ventilation, end expiratory positive pressure, and back up respiratory rate determined by the clinician based on height and weight.
The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
Otros nombres:
|
|
Comparador activo: Standard non-invasive ventilation
approximately 24 hours using standard non-invasive ventilation for as many hours as possible whilst an inpatient in hospital.
|
Standard non-invasive ventilator, with inspiratory and expiratory positive pressure determined by the healthcare professional.
The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
pH at 1+ hour
Periodo de tiempo: 1 hour
|
pH of arterial blood after 1 hour of treatment with non-invasive ventialtion compared baseline value
|
1 hour
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
pH at 4+ hours
Periodo de tiempo: 4+ hours of NIV treatment
|
pH of arterial blood after 4 hours of treatment with non-invasive ventialtion compared to baseline value
|
4+ hours of NIV treatment
|
|
Respiratory Rate at 1+ hour
Periodo de tiempo: 1+ hour of NIV treatment
|
Respiratory rate after 1 hour of treatment with non-invasive ventilation compared to baseline value
|
1+ hour of NIV treatment
|
|
Respiratory rate at 4+ hours
Periodo de tiempo: 4+ hours of NIV treatment
|
Respiratory rate after 4 hours of treatment with non-invasive ventilation compared to baseline value
|
4+ hours of NIV treatment
|
|
overnight mean transcutaneous carbon dioxide
Periodo de tiempo: 24 hours
|
mean overnight transcutaneous carbon dioxide during sleep period
|
24 hours
|
|
PaCO2 at 1+ hours
Periodo de tiempo: 1+ hours of NIV treatment
|
Carbon dixoide level of arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline
|
1+ hours of NIV treatment
|
|
PaCO2 at 4+ hours
Periodo de tiempo: 4+ hours of NIV treatment
|
Carbon dioxide level in arterial blood after 4 hours of treatment with non-invasive ventilation compared to baseline value
|
4+ hours of NIV treatment
|
|
PaO2 at 1+ hour
Periodo de tiempo: 1+ hour of NIV treatment
|
Oxygen level in arterial blood after 1 hour of treatment with non-invasive ventilation compared to baseline value
|
1+ hour of NIV treatment
|
|
PaO2 at 4+ hours
Periodo de tiempo: 4+ hours of NIV treatment
|
Oxygen level in arterial blood after 4+ hours of treatment with non-invasive ventilation compared to baseline value
|
4+ hours of NIV treatment
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Enfermedades de las vías respiratorias
- Apnea
- Trastornos de la respiración
- Trastornos del Sueño Intrínsecos
- Disomnias
- Trastornos del sueño y la vigilia
- Enfermedades pulmonares
- Sobrenutrición
- Trastornos Nutricionales
- Signos y Síntomas Respiratorios
- Síndromes de apnea del sueño
- Obesidad
- Apnea del Sueño Obstructiva
- Enfermedades Pulmonares Obstructivas
- Enfermedad Pulmonar Obstructiva Crónica
- Insuficiencia respiratoria
- Hipoventilación
- Síndrome de hipoventilación por obesidad
- Enfermedades Neuromusculares
Otros números de identificación del estudio
- 10/H0808/56
- R&D No. 2010LF008B (Otro identificador: Research & Development Department, RBH)
- CI/2010/0027 (Otro identificador: Medicines & Healthcare Products Regularoty Agency (devices))
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .