Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypercapnic Response

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Develop Nocturnal Hypercapnic Response Associated to Oxygen Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01120574
• Other study ID #: PR05/05/2007
• Status: Withdrawn
• Phase: N/A
• First received: March 19, 2010
• Last updated: March 21, 2017
• Start date: October 2005
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the clinical benefits of home mechanical ventilation associated to oxygen therapy in COPD patients with chronic respiratory failure (CRF) who develop hypercapnia and nocturnal respiratory acidosis secondary to oxygen administration.

We will include clinically stable COPD patients with hypercapnic CRF who develop a nocturnal hypercapnic response to oxygen (PaCO2 increase on awakening, at night with oxygen, >10 mmHg respect to PaCO2 breathing room air and awake). Obstructive sleep apnoea syndrome (OSAS) will previously have been excluded.

Patients will be admitted to the Pneumology ward where a nocturnal pulsioxymetry breathing oxygen therapy will be performed. Arterial blood gas samples will be taken at awakening (7AM).

Patients who develop a hypercapnic response to oxygen will be randomised into 2 treatment groups:

• Oxygen therapy group

• Home mechanical ventilation plus oxygen therapy group Home mechanical ventilation will be performed with a bilevel pressure ventilator. Functional respiratory variables as well as quality of life and sleep at onset and after 6 months treatment will be compared.

The principal outcome will be the evolution of arterial blood gases (PaCO2) between the two groups.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• Elderly patients < 80 years old.

• COPD (ERS/ATS (FEV1 < 80%, FEV1/FVC < 70%, TLC > 80%)).

• Oxygen therapy indication (PaO2 < 55 mmHg or 55-59 associated to pulmonary arterial hypertension, chronic Cor Pulmonale, Chronic Heart failure, arrhythmias or polyglobulia).

• PaCO2 > 50 mm Hg.

• Clinically stable at least prior to one month.

• Hypercapnic response: increasing PaCO2 > 10 mmHg at 7 a.m after all night with oxygen compared with PaCO2 when awake and without oxygen therapy.

Exclusion Criteria:

• Active smoker.

• Bronchiectasis or tuberculous after-effects.

• Chronic respiratory failure secondary to thorax cage or neuromuscular diseases.

• BMI > 35 kg/m2

• OSAS.

• Locomotor system problems that disable 6 minutes walking test execution.

• Patients with tracheostomy.

• Other serious comorbidity (i.e chronic heart failure functional class > II NYHA, cancer or chronic renal failure that requires dialysis.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypercapnia
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Home mechanical ventilation
Home mechanical ventilation will be performed with a bilevel pressure ventilator.

Locations

Country	Name	City	State
Spain	Fundació Institu de Recerca de l'Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial pressure of CO2.	Follow up of its evolution comparing patients under O2 treatment and patients under O2 + non invasive ventilation treatment.	Six months
Secondary	Functional respiratory tests.	Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).	Six months
Secondary	Quality of life related to health	Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).	6 months
Secondary	Nocturnal hypoventilation (nocturnal pulseoxymetry)	Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).	6 months