Does chronic nocturnal ventilatory support at home after acute respiratory failure treated by (N)IV lead to a prolongation in time to readmission to hospital due to any following exacerbations in these patients compared to medical treatment only?
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time to event is the primary study outcome, for which an event is defined as a
readmission to hospital due to an exacerbation or death. An exacerbation is
defined using a modified version of the definition of Rodriguez-Roisin, as an
event in the natural course of the disease defined as characterized by a change
in the patient*s baseline dyspnoea, cough, and/or sputum that is beyond
day-to-day variations, is acute in onset, and which is treated with an
antibiotics course and/or prednisolon in patients with underlying COPD.
Secondary outcome
- Exacerbations
- Health related quality of life
- Total readmission rate
- Total event rate
- Survival
- Medical costs
- Dyspnoea
- Activities of daily living
- Blood gasses PaO2 and PaCo2
- Inflammation (systemic) markers
- Lung function
- Muscle strength
- Nutritional status
Background summary
Currently, chronic ventilatory support for patients with neuromuscular disease
and kyphoscoliosis in the Netherlands is routinely managed by 4 home mechanical
ventilation (HMV) centres. In contrast, there is no consensus yet how to treat
patients with COPD with chronic respiratory failure after an acute event, due
to the lack of studies in this area. However, some patients in the Netherlands
do receive chronic non invasive ventilation (NIV) after an acute event, while
no evidence is available about its effect in the Netherlands or elsewhere. This
is the reason why we want to investigate if chronic nocturnal NIV at home is
effective in unstable patients with COPD, who remain hypercapnic after
ventilatory support during acute respiratory failure.
Study objective
Does chronic nocturnal ventilatory support at home after acute respiratory
failure treated by (N)IV lead to a prolongation in time to readmission to
hospital due to any following exacerbations in these patients compared to
medical treatment only?
Study design
The protocol concerns a multi-centre, prospective, randomized, controlled
study. It will take 2 years to include all 200 patients from which 100 will
receive non-invasive ventilatory support at night at home as well as medical
treatment, and 100 comprise the control group who will receive medical
treatment only for the duration of 1 year.
The study will take place throughout the whole of the Netherlands, as 3 HMV
(Home Mechanical Ventilation Centres) will cover the entire country. Each
Centre for Home Mechanical Ventilation has its own nurse consultant. If a
patient meets inclusion criteria the treating pulmonologist will contact the
HMV centre that is responsible for chronic ventilatory support in that region.
The nurse consultant will then visit the patient in *his/her own* hospital
where she will provide, if the patient has expressed willingness to enter the
study, the written informed consent. The patient will then be randomised for
either chronic NIV at home or for a control group receiving medication only. If
the patient is randomised to the treatment group, she will firstly let him/her
get used to NIV support whilst the patient is recovering in hospital. It will
take approximately 10 days to recover from the acute exacerbation and during
this period the patient can be properly adjusted to the NIV. During these days
the patient will be asked by the nurse consultant to fill in 4 questionnaires
and perform a 6-minute walking test. Lung function tests and blood gas analyses
are standard procedure for treatment with NIV, and thus can be performed by the
treating department of Pulmonology. After recovery from the exacerbation, the
patient is discharged from the hospital, and NIV will be continued at home.
Intervention
Nocturnal noninvasive ventilatory support will be started by BiPAP (Bilevel
Positive Airway Pressure) in the assist controlled mode (Synchrony,
Respironics, INC, Murrysville, PA, USA) The respiration of the patient will be
maximally supported to reduce the work of breathing. We will start with an IPAP
(Inspiratory Positive Airway Pressure) of 14 cm H2O and an EPAP (Expiratory
Positive Airway Pressure), of 4 cm H2O, Respiratory Rate (RR) of 12 /min,
inspiration: expiration time 1:3, and a short rise time. We will start with a
full face mask and add humidification in case of mouth dryness and nose
problems. BiPAP will be set up aiming to ventilate the patient for at least 6
hours of sleep during the night.
Study burden and risks
A few studies, although somewhat limited in design, showed that NIV reduced
readmission rates and improved survival. Other important potential benefits
that may be realized by study participants include improved air exchange, a
better quality of life, less dyspnoea and an improved quality of sleep. Both
patients and non participating subjects can benefit from this study and its
outcome, but it is also possible that subjects will not receive any benefit
from treatment.
Postbus 30001
9700 RB
NL
Postbus 30001
9700 RB
NL
Listed location countries
Age
Inclusion criteria
1) Chronic Obstructive pulmonary disease (COPD), GOLD severity stage 3 and 4.
2) Minimally 48 hours without ventilatory support after invasive or non invasive ventilatory support during an acute respiratory failure and maximally until discharge.
3) Persistent hypercapnia (PaCO2 > 6.0 kPa) during daytime at rest without ventilatory support.
Exclusion criteria
1) Age < 18 or =>80 years
2) Significant bronchiectasis with recurrent infections
3) Significant heart failure
4) Kyphoscoliosis
5) Neuromuscular disease
6) Obstructive sleep apnea (Apnea Hypopnea Index: AHI >15 /hr)
7) Current use of Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP)
8) Insufficient motivation for chronic ventilatory support;
9) Social circumstances making chronic ventilatory support impossible;
10) Other disease factors limiting life expectations
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL18065.042.07 |