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

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ClinicalTrials.gov Identifier: NCT01120574
Recruitment Status : Withdrawn
First Posted : May 11, 2010
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief 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.


Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Other: Home mechanical ventilation

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Develop Nocturnal Hypercapnic Response Associated to Oxygen Therapy
Actual Study Start Date : October 2005
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
Oxygen therapy group.
Active Comparator: 2
Home mechanical ventilation plus oxygen therapy group.
Other: Home mechanical ventilation
Home mechanical ventilation will be performed with a bilevel pressure ventilator.



Primary Outcome Measures :
  1. Arterial pressure of CO2. [ Time Frame: Six months ]
    Follow up of its evolution comparing patients under O2 treatment and patients under O2 + non invasive ventilation treatment.


Secondary Outcome Measures :
  1. Functional respiratory tests. [ Time Frame: Six months ]
    Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).

  2. Quality of life related to health [ Time Frame: 6 months ]
    Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).

  3. Nocturnal hypoventilation (nocturnal pulseoxymetry) [ Time Frame: 6 months ]
    Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).



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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120574


Locations
Spain
Fundació Institu de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01120574     History of Changes
Other Study ID Numbers: PR05/05/2007
First Posted: May 11, 2010    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Nocturnal hypercapnic response to oxygen
Home mechanical ventilation
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypercapnia
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms