Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

• ClinicalTrials.gov Identifier: NCT00698958
• Recruitment Status: Completed
• First Posted: June 17, 2008
• Last Update Posted: June 17, 2008
• 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
• Information provided by: Hospital Clinic of Barcelona

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 (Clinical Trial)
• 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: June 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 [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Change in PaCO2 from start of mechanical ventilation
2. 6-minute walking test
3. Adaptation failure

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pallero M, Puy C, Güell R, Pontes C, Martí S, Torres F, Antón A, Muñoz 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.

• Responsible Party: Xavier Muñoz Gall, Hospitals Vall d'Hebron
• ClinicalTrials.gov Identifier: NCT00698958
• Other Study ID Numbers: NEUMO/2002/01
• First Posted: June 17, 2008
• Last Update Posted: June 17, 2008
• Last Verified: June 2008

Keywords provided by Hospital Clinic of Barcelona:

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

Additional relevant MeSH terms:

Respiratory Insufficiency; Neuromuscular Diseases; Respiration Disorders; Respiratory Tract Diseases; Nervous System Diseases