Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00698958

First Posted: June 17, 2008

Last Update Posted: June 17, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

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 ^ICMJE

June 13, 2008

First Posted Date ^ICMJE

June 17, 2008

Last Update Posted Date

June 17, 2008

Start Date ^ICMJE

June 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change in PaCO2 from baseline [ Time Frame: 6 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care

Condition ^ICMJE

Chronic Respiratory Failure

Intervention ^ICMJE

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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.
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.
Lack of understanding of the study procedures.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00698958

Other Study ID Numbers ^ICMJE

NEUMO/2002/01

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Xavier Muñoz Gall, Hospitals Vall d'Hebron

Study Sponsor ^ICMJE

Hospital Clinic of Barcelona

Collaborators ^ICMJE

Hospital Universitari Vall d'Hebron Research Institute
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators ^ICMJE

Not Provided

PRS Account

Hospital Clinic of Barcelona

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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