The effect of chronic nocturnal non-invasive ventilatory support at home after ventilatory support during acute respiratory failure in patients with Chronic Obstructive Pulmonary Disease (COPD).

The effect of chronic nocturnal non-invasive ventilatory support at home after ventilatory support during acute respiratory failure in patients with Chronic Obstructive Pulmonary Disease (COPD). - RESCUE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31750

Enrollment

200

Registered

2007-08-10

Start date

2007-12-01

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic bronchitis COPD

Interventions

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 respiratio

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: 1) Age 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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
- 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	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)