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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02093-42 | Other Identifier | ID-RCB |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mask | Device | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1 to 10 self assessment scale | Comfort will be assessed by a numerical self-assessment scale from 0 to 10. | throughout the study (an average of 10 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who prefer one type of mask over the other | throughout the study (an average of 10 months) | |
| Percentage of leakage volume compared to the tidal leakage volume | throughout the study (an average of 10 months) |
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Inclusion Criteria:
Indication of NIV, carried out by the physicians in charge of the patient, among the following:
Exclusion Criteria:
Formal contraindication to NIV among:
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Adult patients hospitalized in intensive care, continuous monitoring unit or pulmonary intensive care with an indication for NIV.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe CARPENTIER, MD | Contact | 0145217138 | 33 | christophe.carpentier@aphp.fr |
| Tai PHAM, MD | Contact | 0145217138 | +33 | tai.pham@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christophe CARPENTIER, MD | Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Henri Mondor - Réanimation/ Unité de Surveillance Continue | Créteil | France |
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| ID | Term |
|---|---|
| D006935 | Hypercapnia |
| D010845 | Obesity Hypoventilation Syndrome |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020181 | Sleep Apnea, Obstructive |
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| ID | Term |
|---|---|
| D008397 | Masks |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D011482 | Protective Devices |
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| Dyspnea | throughout the study (an average of 10 months) |
| Number of interventions on mask position by nurses during NIV session | throughout the study (an average of 10 months) |
| Number of side effects | throughout the study (an average of 10 months) |
| CHU Bicêtre - Unité de Soins Intensifs Pneumologique | Le Kremlin-Bicêtre | 94270 | France |
|
| CHU Bicêtre - USC | Le Kremlin-Bicêtre | 94270 | France |
|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D007040 | Hypoventilation |
| D012131 | Respiratory Insufficiency |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D000067393 | Personal Protective Equipment |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |