Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

• Sponsor: Hospital Clinic of Barcelona (Other)
• Overall Status: Completed
• CT.gov ID: NCT00698958
• Collaborator: Hospital Universitari Vall d'Hebron Research Institute (Other), Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
• Enrollment: 52
• Arms: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Respiratory Failure	Procedure: Ambulatory adaptation to non- invasive mechanical ventilation for 7 days; Procedure: Hospital based adaptation to non- invasive mechanical ventilation for 7 days	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Study Start Date: Jun 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Hospital based adaptation to non- invasive mechanical ventilation for 7 days	Procedure: Hospital based adaptation to non- invasive mechanical ventilation for 7 days; Hospital based adaptation to non- invasive mechanical ventilation for 7 days
Experimental: 2 Ambulatory adaptation to non- invasive mechanical ventilation for 7 days	Procedure: Ambulatory adaptation to non- invasive mechanical ventilation for 7 days; Ambulatory adaptation to non- invasive mechanical ventilation for 7 days

Outcome Measures

Primary Outcome Measures

1. Change in PaCO2 from baseline [6 months]

Secondary Outcome Measures

1. Change in PaCO2 from start of mechanical ventilation []

2. 6-minute walking test []

3. Adaptation failure []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Stable disease.

2. Airway access through nasal mask.

3. Ability to provide written informed consent.

4. 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.

1. Patients with acute symptoms requiring hospital admission.

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

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

4. 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.

5. Lack of understanding of the study procedures.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00698958
• Other Study ID Numbers: NEUMO/2002/01
• First Posted: Jun 17, 2008
• Last Update Posted: Jun 17, 2008
• Last Verified: Jun 1, 2008

• Keywords provided by , ,: Respiratory insufficiency; Hypercapnic chronic respiratory failure secondary to neuromuscular diseases or alterations of thoracic cage
• Additional relevant MeSH terms: Respiratory Insufficiency; Neuromuscular Diseases

Study Results

No Results Posted as of Jun 17, 2008