Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mask plus CO2 removal device | Experimental | a "traditional" mask with inserted a new CO2 removal device that is called DiMax Zero Total face mask "R", |
|
| traditional face mask | Active Comparator | Traditional mask without a CO2 clearance device inserted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DiMax Zero Total face mask "R", | Device | a non-CO2 rebreathing device included directly in the full face mask |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| stefano nava | Contact | 3333751828 | stefanava@gmail.com | |
| vittoria comellini | Contact | vittoria.comellini@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| stefano nava | Azienda Ospedaliera Sant'Orsola | Principal Investigator |
Not provided
not allow to release individual data
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| traditional face mask | Device | a traditional mask without a non-CO2 rebreathing device included directly in the full face mask |
|