Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode.
1 other identifier
interventional
26
1 country
1
Brief Summary
To evaluate the polysomnographic performance of an automatic ventilatory mode compared with the gold standard (manual polysomnographic titration) to adjust chronic non-invasive ventilation by means of a randomized cross-over study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2018
CompletedFirst Submitted
Initial submission to the registry
March 7, 2019
CompletedFirst Posted
Study publicly available on registry
March 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2024
CompletedFebruary 29, 2024
February 1, 2024
5.5 years
March 7, 2019
February 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Partial pressure of carbon dioxide (PaCO2)
Measure levels after each polysomnography using arterial blood gases
two weeks
Partial pressure of oxygen (PaO2)
Measure levels after each polysomnography using arterial blood gases
two weeks
Secondary Outcomes (1)
Oxygen saving time below 90% (CT90%)
one month
Study Arms (2)
MANUAL
ACTIVE COMPARATORManual titration of non-invasive mechanical ventilation using polysomnography and randomized
AUTOMATIC
ACTIVE COMPARATORAutomatic titration of the non-invasive mechanical ventilation using the same device in an automatic mode with assured volume and pressure support.
Interventions
Correction of night ventilation through an automatic mode of ventilation with assured volume with pressure support
Correction of night ventilation through a manual titration of non-invasive mechanical ventilation using polysomnography.
Eligibility Criteria
You may qualify if:
- Diurnal hipercapnia and/or nocturnal hypoventilation (CT90% \>10%)
You may not qualify if:
- Under 18 years old.
- Presence of severe uncontrolled cardiac comorbidity.
- Impossibility to achieve adaptation to therapy in the training session.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clinic Barcelona.
Barcelona, 08036, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CRISTINA EMBID LOPEZ, PHD
Hospital Clinic
- PRINCIPAL INVESTIGATOR
MONICA C MATUTE VILLACIS, MD
Hospital Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 7, 2019
First Posted
March 13, 2019
Study Start
June 15, 2018
Primary Completion
December 31, 2023
Study Completion
February 15, 2024
Last Updated
February 29, 2024
Record last verified: 2024-02