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

Tracking Information

• First Submitted Date: June 13, 2008
• First Posted Date: June 17, 2008
• Last Update Posted Date: June 17, 2008
• Study Start Date: June 2003
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: June 16, 2008): Change in PaCO2 from baseline [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 16, 2008)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ambulatory Adaptation to Non-Invasive Mechanical Ventilation
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Chronic Respiratory Failure

Intervention

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

Study Arms

• Active Comparator: 1
  Hospital based adaptation to non- invasive mechanical ventilation for 7 days
  Intervention: Procedure: Hospital based adaptation to non- invasive mechanical ventilation for 7 days
• Experimental: 2
  Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
  Intervention: Procedure: Ambulatory adaptation to non- invasive mechanical ventilation for 7 days

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 16, 2008): 52
• Original Actual Enrollment: Same as current
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00698958
• Other Study ID Numbers: NEUMO/2002/01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Xavier Muñoz Gall, Hospitals Vall d'Hebron
• Study 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

• Investigators: Not Provided
• PRS Account: Hospital Clinic of Barcelona
• Verification Date: June 2008