Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

Chronic Respiratory Failure Clinical Trial

Official title:

A Randomized Trial to Compare the Effectiveness of Hospital or Ambulatory Approach for Adaptation to Non-Invasive Mechanical Ventilation in Patients With Chronic Respiratory Failure Secondary to Neuromuscular Diseases or Thoracic Cage Alterations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698958
• Other study ID #: NEUMO/2002/01
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2008
• Last updated: June 16, 2008
• Start date: June 2003

Study information

• Verified date: June 2008
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

A randomised study to assess the effectiveness of ambulatory adaptation to non-invasive mechanical ventilation in patient with hypercapnic respiratory failure secondary to neuromuscular diseases or alterations in thoracic cage in comparison with hospital adaptation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 75

2. Chronic respiratory insufficiency secondary to neuromuscular disease or thoracic cage alterations with indication of non-invasive mechanical ventilation (presence of fatigue, dyspnea, morning headache, etc) plus one of the following criteria):

• PaCO2 > 45 mmHg

• Night time oxygen saturation < 88% at least for 5 consecutive minutes

• In neuromuscular diseases, PIM < 60 cmH2O or FVC < 50% of theoretical.

3. Stable disease.

4. Airway access through nasal mask.

5. Ability to provide written informed consent.

6. Ability to attend the visits

Exclusion Criteria:

1. Contraindications for mechanical ventilation:

• Patient with terminal disease or vegetative state

• Lack of motivation of the patient

• Lack of family or social support

• Patients clinically unstable

• Agitation or lack of co-operation

• Depression.

2. Patients with acute symptoms requiring hospital admission.

3. Need for airway access through tracheostomy, face mask or mouth piece.

4. Relevant comorbidity (ie. heart failure, diabetes non controlled, infections, malignancies, etc.) leading to difficulties in adaptation to ventilation.

5. Use (for 7 days or more) of CNS depressors(benzodiazepines, antihistamines H1, tricyclic antidepressants , antiepileptic or antipsychotic drugs ) in the 30-day period prior to inclusion, or expected need for such drugs during the study.

6. Lack of understanding of the study procedures.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Respiratory Failure
• Neuromuscular Diseases
• Respiratory Insufficiency

Intervention

Procedure:
• Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
• Hospital based adaptation to non- invasive mechanical ventilation for 7 days
Hospital based adaptation to non- invasive mechanical ventilation for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Universitari Vall d'Hebron Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PaCO2 from baseline		6 months	No
Secondary	Change in PaCO2 from start of mechanical ventilation			No
Secondary	6-minute walking test			No
Secondary	Adaptation failure			No