CO2 Clearance During Noninvasive Ventilation (NIV)
Evaluation of a New System to Clear CO2 During Noninvasive Ventilation (NIV)
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
In this randomized cross over study the investigators will evaluate the effects on gas exchange and patients' tolerance of a new CO2 non rebreathing devices incorporated in the mask vs the traditional mask COPD patients undergoing NIV for an episode of Acute Hypercapnia Respiratory Failure, will be randomized after at least 12 hour of ventilation to 1 h.trial with the usual full face mask or the same mask with the addition of a new CO2 clearance device
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 Jan 2019
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
November 23, 2018
CompletedFirst Posted
Study publicly available on registry
November 28, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedNovember 28, 2018
November 1, 2018
5 months
November 23, 2018
November 26, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
changes in arterial blood gases (ABGs)
Recording of carbon dioxide arterial tensione and oxygen arterial tension using an arterial puncture performed in the radial artery
immediate
patient's tolerance to the mask
the tolerance will be recorded using an ad hoc scale
immediate
Study Arms (2)
mask plus CO2 removal device
EXPERIMENTALa "traditional" mask with inserted a new CO2 removal device that is called DiMax Zero Total face mask "R",
traditional face mask
ACTIVE COMPARATORTraditional mask without a CO2 clearance device inserted
Interventions
a non-CO2 rebreathing device included directly in the full face mask
a traditional mask without a non-CO2 rebreathing device included directly in the full face mask
Eligibility Criteria
You may qualify if:
- COPD diagnosis
- sign inform consent
- able to tolerate the application of NIV
You may not qualify if:
- inability to tolerate the mask
- contraindication to NIV
- cancer, neurological diseases, and need of another life support besides the ventilator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
stefano nava
Azienda Ospedaliera Sant'Orsola
Central Study Contacts
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
- Chief of Pulmonary and Critical Care
Study Record Dates
First Submitted
November 23, 2018
First Posted
November 28, 2018
Study Start
January 1, 2019
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
November 28, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share
not allow to release individual data