REspiratory Support in COPD after acUte Exacerbation.

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).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25398

Enrollment

200

Registered

2007-09-25

Start date

2007-11-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

1. COPD

Interventions

The intervention group will receive non-invasive ventilatory support at night at home as well as medical treatment, and the control group will receive standard medical treatment only for the duration

Eligibility

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 75 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.	—

Secondary

Measure	Time frame
1. Exacerbations; 2. Health related quality of life; 3. Total readmission rate; 4. Total event rate; 5. Survival; 6. Medical costs; 7. Dyspnoea; 8. Activities of daily living; 9. Exercise tolerance; 10. Blood gasses PaO2 and PaCo2; 11. Lung function; 12. Inflammation (systemic) markers; 13. Muscle strength; 14. Nutritional status; if possible in specialised centres.	—

Contacts

Public ContactF.M. Struik

Hanzeplein 1

f.m.struik@int.umcg.nl+31 50 3619505

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)