Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: Chronic Respiratory Failure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00698958

NEUMO/2002/01

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

52 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

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

2

Experimental group

Description:

Ambulatory adaptation to non- invasive mechanical ventilation for 7 days

Treatment:

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