Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00698958

Enrollment

Registered

2008-06-17

Start date

2003-06-30

Completion date

Unknown

Last updated

2008-06-17

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

Conditions

Chronic Respiratory Failure

Keywords

Respiratory insufficiency, Hypercapnic chronic respiratory failure secondary to neuromuscular diseases or alterations of thoracic cage

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.

Interventions

PROCEDUREAmbulatory adaptation to non- invasive mechanical ventilation for 7 days

Ambulatory adaptation to non- invasive mechanical ventilation for 7 days

PROCEDUREHospital based adaptation to non- invasive mechanical ventilation for 7 days

Hospital based adaptation to non- invasive mechanical ventilation for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change in PaCO2 from baseline	6 months

Secondary

Measure	Time frame
6-minute walking test	—
Adaptation failure	—
Change in PaCO2 from start of mechanical ventilation	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026