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lack of enrollement
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VNI Versus is a clinical, prospective, randomized, cross over study, aiming to compare two mechanical ventilators during non-invasive ventilation for patient suffering from respiratory acidosis.
This study will compare a dedicated ventilator for Non Invasive Ventilation (NIV) functioning with a turbine and with vented mask (exhalation by a calibrated leak) and a dedicated ventilator for Intensive Care Unit (ICU), functioning with non-vented masks and an exhalation valve.
Patient will be randomized before the first NIV session lasting 2 hours. After a two hours wash-out, a second NIV treatment will be delivered with the other ventilator for duration of 2 hours.
Arterial blood samples will be collected at the beginning and the end of each session of NIV. A transcutaneous captor of dioxide carbon pressure (PCO2) will also be used for patient monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Homecare ventilator | Experimental | NIV with a dedicated ventilator for homecare, functioning with a turbine and with vented mask (exhalation by a calibrated leak) |
|
| ICU ventilator | Active Comparator | NIV with a dedicated ICU ventilator, functioning with non-vented masks and an exhalation valve. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Invasive Ventilation with Homecare ventilator | Procedure |
| ||
| Non-Invasive Ventilation with ICU ventilator |
| Measure | Description | Time Frame |
|---|---|---|
| Carbon dioxide arterial pressure (PaCO2) | Absolute decrease in carbon dioxide arterial pressure (PaCO2) after 2 hours of ventilation | After 2 hours of NIV |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial blood acidity (pH) after 2 hours of NIV | Correction of arterial blood acidity (pH) after 2 hours of NIV | after 2 hours of NIV |
| Transcutaneous PCO2 | Kinetic of the PaCO2 correction, monitored via transcutaneous PCO2 captor. |
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Inclusion Criteria:
Exclusion Criteria:-Patient age under 18
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Michallon | Grenoble | 38000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18635484 | Background | Akada S, Takeda S, Yoshida Y, Nakazato K, Mori M, Hongo T, Tanaka K, Sakamoto A. The efficacy of dexmedetomidine in patients with noninvasive ventilation: a preliminary study. Anesth Analg. 2008 Jul;107(1):167-70. doi: 10.1213/ane.0b013e3181732dc2. | |
| 22406958 | Background | Carteaux G, Lyazidi A, Cordoba-Izquierdo A, Vignaux L, Jolliet P, Thille AW, Richard JM, Brochard L. Patient-ventilator asynchrony during noninvasive ventilation: a bench and clinical study. Chest. 2012 Aug;142(2):367-376. doi: 10.1378/chest.11-2279. |
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| Procedure |
|
| 6 hours |
| Börg dyspnea scale | 6 hours |
| RASS score | 6 hours |
| Nurse satisfaction survey | 6 hours |
| Patient satisfaction survey | 6 hours |
| 21424246 | Background | Chiumello D, Chevallard G, Gregoretti C. Non-invasive ventilation in postoperative patients: a systematic review. Intensive Care Med. 2011 Jun;37(6):918-29. doi: 10.1007/s00134-011-2210-8. Epub 2011 Mar 18. |
| 19682735 | Background | Ferrer M, Sellares J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12. |
| 21680944 | Background | Girault C, Bubenheim M, Abroug F, Diehl JL, Elatrous S, Beuret P, Richecoeur J, L'Her E, Hilbert G, Capellier G, Rabbat A, Besbes M, Guerin C, Guiot P, Benichou J, Bonmarchand G; VENISE Trial Group. Noninvasive ventilation and weaning in patients with chronic hypercapnic respiratory failure: a randomized multicenter trial. Am J Respir Crit Care Med. 2011 Sep 15;184(6):672-9. doi: 10.1164/rccm.201101-0035OC. |
| 9515855 | Background | Janssens JP, Howarth-Frey C, Chevrolet JC, Abajo B, Rochat T. Transcutaneous PCO2 to monitor noninvasive mechanical ventilation in adults: assessment of a new transcutaneous PCO2 device. Chest. 1998 Mar;113(3):768-73. doi: 10.1378/chest.113.3.768. |
| 16616558 | Background | Peter JV, Moran JL, Phillips-Hughes J, Graham P, Bersten AD. Effect of non-invasive positive pressure ventilation (NIPPV) on mortality in patients with acute cardiogenic pulmonary oedema: a meta-analysis. Lancet. 2006 Apr 8;367(9517):1155-63. doi: 10.1016/S0140-6736(06)68506-1. |
| ID | Term |
|---|---|
| D000142 | Acidosis, Respiratory |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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