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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Respiratory Failure
• Intervention / Treatment: 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
• Enrollment (Actual): 52
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in PaCO2 from baseline	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2003

Study Registration Dates

• First Submitted: June 13, 2008
• First Submitted That Met QC Criteria: June 16, 2008
• First Posted (ESTIMATE): June 17, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 17, 2008
• Last Update Submitted That Met QC Criteria: June 16, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Respiratory insufficiency; Hypercapnic chronic respiratory failure secondary to neuromuscular diseases or alterations of thoracic cage
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Neuromuscular Diseases
• Other Study ID Numbers: NEUMO/2002/01