- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03756415
CO2 Clearance During Noninvasive Ventilation (NIV)
Evaluation of a New System to Clear CO2 During Noninvasive Ventilation (NIV)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: stefano nava
- Phone Number: 3333751828
- Email: stefanava@gmail.com
Study Contact Backup
- Name: vittoria comellini
- Email: vittoria.comellini@aosp.bo.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mask plus CO2 removal device
a "traditional" mask with inserted a new CO2 removal device that is called DiMax Zero Total face mask "R",
|
a non-CO2 rebreathing device included directly in the full face mask
|
Active Comparator: traditional face mask
Traditional mask without a CO2 clearance device inserted
|
a traditional mask without a non-CO2 rebreathing device included directly in the full face mask
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in arterial blood gases (ABGs)
Time Frame: immediate
|
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
Time Frame: immediate
|
the tolerance will be recorded using an ad hoc scale
|
immediate
|
Collaborators and Investigators
Investigators
- Principal Investigator: stefano nava, Azienda Ospedaliera Sant'Orsola
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Stefano Nava1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Hypercapnic Respiratory Failure
-
Assiut UniversityNot yet recruitingAcute Hypoxemic Respiratory Failure | Acute Hypercapnic Respiratory FailureEgypt
-
Yonsei UniversityNot yet recruitingRespiratory Failure | Respiratory Insufficiency | Hypercapnic Respiratory Failure | Acute Hypoxemic Respiratory Failure | Acute Hypercapnic Respiratory Failure | Ventilatory Depression | Hypoxemic Respiratory Failure | Respiratory Depression | Hypoxemic Acute Respiratory Failure | Hypercapnic AcuteKorea, Republic of
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity of Turin, ItalyUnknownPatients With Acute Hypercapnic Respiratory FailureItaly
-
Assiut UniversityNot yet recruitingAcute Hypercapnic Respiratory Failure
-
Assiut UniversityNot yet recruitingComparison Between HVNI vs Noninvasive Ventilation for Acute Hypercapnic Respiratory Failure
-
Azienda Ospedaliero Universitaria Maggiore della...CompletedAcute Hypoxic - Hypercapnic Respiratory Failure (ARF)Italy
-
Belfast Health and Social Care TrustRecruitingAcute Hypercapnic Respiratory Failure | Acute Exacerbation of COPDUnited Kingdom
-
Siriraj HospitalRecruitingAcute Hypoxemic Respiratory Failure | Acute Hypercapnic Respiratory FailureThailand
-
Fisher and Paykel HealthcareCentre hospitalier de l'Université de Montréal (CHUM); Institut universitaire...Not yet recruitingAcute Hypoxemic Respiratory Failure | Acute Hypercapnic Respiratory Failure
-
University of Missouri-ColumbiaHayek MedicalRecruitingAcute Hypercapnic Respiratory FailureUnited States
Clinical Trials on DiMax Zero Total face mask "R",
-
Corporacion Parc TauliTerminatedRespiratory InsufficiencySpain
-
Tufts Medical CenterRhode Island HospitalCompletedAcute Respiratory InsufficiencyUnited States
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedChronic Obstructive Pulmonary Disease | Hypercapnic Respiratory FailureItaly
-
Ospedale S. Giovanni BoscoCompletedAcute Respiratory FailureItaly