Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

NCT00698958 | Completed Phase 4

• 1 other identifier: NEUMO/2002/01
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Respiratory Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in PaCO2 from baseline

  6 months

Secondary Outcomes (3)

• Change in PaCO2 from start of mechanical ventilation

• 6-minute walking test

• Adaptation failure

Study Arms (2)

1

ACTIVE COMPARATOR

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

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

2

EXPERIMENTAL

Ambulatory adaptation to non- invasive mechanical ventilation for 7 days

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

Interventions

Ambulatory adaptation to non- invasive mechanical ventilation for 7 days PROCEDURE

Ambulatory adaptation to non- invasive mechanical ventilation for 7 days

2

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

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

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75
• 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.
• Stable disease.
• Airway access through nasal mask.
• Ability to provide written informed consent.
• Ability to attend the visits

You may not qualify if:

• 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.
• Patients with acute symptoms requiring hospital admission.
• Need for airway access through tracheostomy, face mask or mouth piece.
• Relevant comorbidity (ie. heart failure, diabetes non controlled, infections, malignancies, etc.) leading to difficulties in adaptation to ventilation.
• Lack of understanding of the study procedures.

Sponsors & Collaborators

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

Related Publications (1)

• Pallero M, Puy C, Guell R, Pontes C, Marti S, Torres F, Anton A, Munoz X. Ambulatory adaptation to noninvasive ventilation in restrictive pulmonary disease: a randomized trial with cost assessment. Respir Med. 2014 Jul;108(7):1014-22. doi: 10.1016/j.rmed.2014.04.016. Epub 2014 May 2.

  PMID: 24837977 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: June 1, 2003
• Last Updated: June 17, 2008

Record last verified: 2008-06