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Difficulty in enrolling new patients
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This study compares a volume targeted pressure support non-invasive ventilation with an automatic PEP regulation (AVAPS-AE mode) to a pressure support non-invasive ventilation (S/T mode) in patients with acute hypercapnic respiratory failure with acidosis. This study focuses on patients at risk of obstructive apneas or obesity-hypoventilation syndrom (BMI≥30 kg/m²). Half of participants (33 patients) will receive non invasive ventilation with AVAPS-AE mode, the other half will receive non-invasive ventilation with S/T mode.
So far, in respiratory intensive care units, the usual treatment of patients with acute hypercapnic respiratory failure with acidosis is non-invasive ventilation set with a pressure support mode (S/T or VS/AI mode depending on the ventilator manufacturer).
AVAPS-AE mode is a volume targeted pressure support mode with an automatic PEP. With the forced oscillations method, the ventilator is able to detect the obstruction and the resistances of upper airways.
It allows the ventilator to change its pressure settings to keep the targeted volume and avoid apneas and hypoventilation.
That is why in patients with a BMI > 30 kg/m², at risk of obesity hypoventilation syndrom or obstructive apneas, this ventilation mode may be interesting.
AVAPS-AE has been evaluated in the home ventilation showing it is as efficient as S/T mode in controlling PaCO2.
However it has never been compared to S/T mode in acute respiratory failure care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVAPS-AE mode | Experimental | A volume targeted pressure support ventilation mode |
|
| S/T mode | Active Comparator | A pressure support ventilation mode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVAPS-AE mode during NIV | Device | NIV will be setup in AVAPS-AE mode, with a Trilogy ventilation device (Respironics, Murrysville, PA). The range of positive expiratory pressure will be set between 4 and 14 cmH2O. The range of inspiratory pressure support will be set between 14 and 24 cmH2. The target tidal volume will be set to achieve 8 to 10 mL/kg of ideal body weight (Size (m) * Size (m) * 23). |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of hypercapnia | Time between admission and resolution of hypercapnia (≤ 6.5 kPa) | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of persistent apneic events on NIV (/h) during the first night | Comparison of persistent apneic events on NIV (/h) during the first night (determined with a respiratory polygraph) between S/T mode arm and AVAPS-AE mode arm (determined with an oxymeter) | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoine Cuvelier, MD, PhD | UH Rouen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Rouen | Rouen | 76031 | France |
Data will be avaible by Email request to Dr. Patout Maxime
Within 2 years of study publication
Researchers in the field of acute/chronic respiratory failure.
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The patients are randomized in 2 arms at their admission :
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The ventilator used in both arms will be similar in appareance.
|
| S/T mode during NIV | Device | NIV will be setup in ST mode, with a Trilogy ventilation device (Respironics, Murrysville, PA). The physician will decide the level of positive expiratory pressure and of pressure support. |
|
| Comparison of patient-ventilator asynchronisms during NIV (/h) |
Comparison of patient-ventilator asynchronisms during NIV (/h) between S/T mode arm and AVAPS-AE mode arm (determined with ventilator datas and a respiratory polygraph) |
| through study completion, an average of 1 year |
| Comparison of time during NIV with a oxygen saturation below 90% | Comparison of time during NIV with a oxygen saturation below 90% between S/T mode arm and AVAPS-AE mode arm (determined with an oxymeter) | through study completion, an average of 1 year |
| Comparison of NIV confort | Comparison of NIV confort between S/T mode arm and AVAPS-AE mode arm (NIV confort determined by a visual scale: 0: very comfortable to 10:not comfortable at all) | through study completion, an average of 1 year |
| Comparison of length of stay | Comparison of length of stay between S/T mode arm and AVAPS-AE mode arm | through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D000142 | Acidosis, Respiratory |
| D009765 | Obesity |
| D020181 | Sleep Apnea, Obstructive |
| D001049 | Apnea |
| D006935 | Hypercapnia |
| D000138 | Acidosis |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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