An observational study in COPD Exacerbation, Hypercapnia and Hypoventilation Obesity Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
A sub-nasal mask with a skirt that fits the nostrils and with a dedicated port for the nasogastric tube has recently been introduced. This interface has never been compared to nasal-oral masks. We hypothesise that such a sub-nasal mask increases comfort compared to a conventional naso-oral mask. The primary objective is to compare the comfort of the sub-nasal mask with that of a standard naso-oral mask.
Non-invasive ventilation (NIV) is a first-line treatment for many conditions encountered in the ICU. This technique requires training of heath professionals, appropriate equipment, optimisation of ventilator settings and good cooperation from the patient. Indeed, NIV failures lead ton invasive mechanical ventilation, thus increasing morbidity and mortality. These failures are favoured by the patient's poor tolerance to NIV. The success of the treatment depends greatly on the patient's compliance and comfort. The choice of the mask is therefore essential. There are different types of interface, such as the full-face helmet, the face mask, the nasal-oral mask or the nasal mask. The nasal-oral mask rmains the most commonly used interface. Recommendations emphasise the importance of choosing a mask that is the right size and best tolerated by the patient. Despite benefits of NIV, there are a number of potential complications: skin lesions at pressure points, particulaly at the nasal bridge, gastric distension, barotrauma, haemodynamic effects of positive presure ventilation, claustrophobia, anxiety, difficulty in speaking and eating, dry eyes, patient-ventilator asynchrony. Some of these complications depend on the type of mask used. a sub-nasal mask with a skirt that fits the nostrils and a dedicated port for the nasogastric tube has recently been introduced. To our knowledge, this interface has never been compared to commercially avaible nasal-oral masks.
156 studies on the registry are indexed under Hypercapnia; 31 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 31 observational studies indexed under Hypercapnia.
Browse Hypercapnia studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients hospitalized in intensive care, continuous monitoring unit or pulmonary intensive care with an indication for NIV.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Indication of NIV, carried out by the physicians in charge of the patient, among the following:
Exclusion Criteria:
Formal to NIV among:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients will be their own comparator. Patients will try both mask for 10 min and then decide which mask they want for the rest of the ventilation
Also known as: oronasal mask or subnasal mask
1 to 10 self assessment scale
Comfort will be assessed by a numerical self-assessment scale from 0 to 10.
Time frame: throughout the study (an average of 10 months)
Percentage of subjects who prefer one type of mask over the other
Time frame: throughout the study (an average of 10 months)
Percentage of leakage volume compared to the tidal leakage volume
Time frame: throughout the study (an average of 10 months)
Dyspnea
Time frame: throughout the study (an average of 10 months)
Number of interventions on mask position by nurses during NIV session
Time frame: throughout the study (an average of 10 months)
Number of side effects
Time frame: throughout the study (an average of 10 months)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2024; primary completion for Oct 2024, 9 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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