CO2 Clearance During Noninvasive Ventilation (NIV)
Primary Purpose
Acute Hypercapnic Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DiMax Zero Total face mask "R",
traditional face mask
Sponsored by
About this trial
This is an interventional treatment trial for Acute Hypercapnic Respiratory Failure
Eligibility Criteria
Inclusion Criteria:
- COPD diagnosis
- sign inform consent
- able to tolerate the application of NIV
Exclusion Criteria:
- inability to tolerate the mask
- contraindication to NIV
- cancer, neurological diseases, and need of another life support besides the ventilator
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
mask plus CO2 removal device
traditional face mask
Arm Description
a "traditional" mask with inserted a new CO2 removal device that is called DiMax Zero Total face mask "R",
Traditional mask without a CO2 clearance device inserted
Outcomes
Primary Outcome Measures
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
patient's tolerance to the mask
the tolerance will be recorded using an ad hoc scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03756415
First Posted
November 23, 2018
Last Updated
November 26, 2018
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1. Study Identification
Unique Protocol Identification Number
NCT03756415
Brief Title
CO2 Clearance During Noninvasive Ventilation (NIV)
Official Title
Evaluation of a New System to Clear CO2 During Noninvasive Ventilation (NIV)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
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 (FM) or the same mask with the addition of a new CO2 clearance device (FM+d) In the interval between NIV sessions, arterial blood gases will be monitored and if PaCO2 will return to a baseline value with a tolerance of 10%, the patients will undergo another 1 h trial using the other mask.
The subjects will be studied in the sitting position and asked to relax throughout the period of the study.
The patients will be ventilated using pressure support ventilation (PSV) The order of use of the two interfaces will be determined for each patient by a previously generated randomized sequence.
FIO2 will be adjusted to obtain oxygen saturation around 92% at baseline and never modified throughout the study.
End-expiratory pressure will always fixed at 2 cm H2O, and trigger sensitivity will set at -0.5 cm H2O.
Inspiratory assistance during either PSV will be titrated to achieve a tidal volume between 6-8 mL/kg while avoiding occurrence of discomfort or visually assessed "wasted efforts".
The ventilatory settings will determined at the beginning of the first trial, and maintained unmodified throughout all the 3 runs.
Patient tolerance to NIMV, defined as the level of comfort using the different mask, will be assessed by means of a scale used and validated in previous studies that is defined as follows: 1, bad; 2, poor; 3, sufficient; 4, good; 5, very good. The patients were asked by the respiratory therapist to answer the following question: "How do the patient feel your breathing is using this mask?" The patient will give the score to the therapist at the end of each run, just before ABG measurements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypercapnic Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mask plus CO2 removal device
Arm Type
Experimental
Arm Description
a "traditional" mask with inserted a new CO2 removal device that is called DiMax Zero Total face mask "R",
Arm Title
traditional face mask
Arm Type
Active Comparator
Arm Description
Traditional mask without a CO2 clearance device inserted
Intervention Type
Device
Intervention Name(s)
DiMax Zero Total face mask "R",
Intervention Description
a non-CO2 rebreathing device included directly in the full face mask
Intervention Type
Device
Intervention Name(s)
traditional face mask
Intervention Description
a traditional mask without a non-CO2 rebreathing device included directly in the full face mask
Primary Outcome Measure Information:
Title
changes in arterial blood gases (ABGs)
Description
Recording of carbon dioxide arterial tensione and oxygen arterial tension using an arterial puncture performed in the radial artery
Time Frame
immediate
Title
patient's tolerance to the mask
Description
the tolerance will be recorded using an ad hoc scale
Time Frame
immediate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD diagnosis
sign inform consent
able to tolerate the application of NIV
Exclusion Criteria:
inability to tolerate the mask
contraindication to NIV
cancer, neurological diseases, and need of another life support besides the ventilator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
stefano nava
Phone
3333751828
Email
stefanava@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
vittoria comellini
Email
vittoria.comellini@aosp.bo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
stefano nava
Organizational Affiliation
Azienda Ospedaliera Sant'Orsola
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
not allow to release individual data
Learn more about this trial
CO2 Clearance During Noninvasive Ventilation (NIV)
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