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| ID | Type | Description | Link |
|---|---|---|---|
| B406201834736 | Other Identifier | CCB - Comité consultatif de Bioéthique de Belgique | |
| P2018/067 | Other Identifier | Erasme - ULB Ethics Committee |
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This study aims to evaluate the effectiveness of the High Flow Nasal Cannula (HFNC) for the preoxygenation of obese patients undergoing a general anesthesia. The HFNC interface is compared to a standard anesthesia FaceMask (FM) preoxygenation with Continuous Positive Airway Pressure (CPAP), the current gold standard procedure for obese induction.
The interest of HFNC preoxygenation is to increase the "safe apnea time" before critical arterial desaturation, useful in the management of difficult airways, especially in subjects with reduced respiratory reserves such as the obese.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFNC - High Flow Nasal Cannula | Experimental | Participants are preoxygenated by High Flow Nasal Cannula (HFNC) OptiFlow. |
|
| FM - FaceMask | Active Comparator | Participants are preoxygenated by standard anesthesia FaceMask. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow Nasal Cannula (HFNC) | Device | Preoxygenation trough High Flow Nasal Cannula (HFNC) at 100% FiO2, 50 liters/min and closed mouth. After Rapid Sequence Induction (RSI), maintenance of apnea with HFNC at 100% FiO2, 70 liters/min and jaw thrust. At time of peripheral oxygen saturations (SpO2) decreases by 2% or after 10 minutes of apnea, the participant is intubated. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Residual Capacity (FRC) variation | The difference of FRC, estimated by lung Electrical Impedance Tomography (EIT), during general anesthesia induction (from a base period to the mechanical ventilation). | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time of safe apnea | The time (seconds) of apnea following preoxygenation and muscle relaxation before to peripheral oxygen saturations (SpO2) decreases by 2%, or the apnea time reaches 600 seconds. | 20 minutes |
| Lowest SpO2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Ricottilli, MD | Erasme University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme University Hospital | Brussels | 1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29144160 | Background | Drake MG. High-Flow Nasal Cannula Oxygen in Adults: An Evidence-based Assessment. Ann Am Thorac Soc. 2018 Feb;15(2):145-155. doi: 10.1513/AnnalsATS.201707-548FR. | |
| 29071075 | Background | Okuda M, Tanaka N, Naito K, Kumada T, Fukuda K, Kato Y, Kido Y, Okuda Y, Nohara R. Evaluation by various methods of the physiological mechanism of a high-flow nasal cannula (HFNC) in healthy volunteers. BMJ Open Respir Res. 2017 Jul 20;4(1):e000200. doi: 10.1136/bmjresp-2017-000200. eCollection 2017. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Standard anesthesia FaceMask (FM) | Device | Preoxygenation trough standard anesthesia FaceMask (FM) at 100% FiO2, 12 liters/min, CPAP 7 cmH2O. After Rapid Sequence Induction (RSI), maintenance of apnea without mask. At time of peripheral oxygen saturations (SpO2) decreases by 2% or after 10 minutes of apnea, the participant is intubated. |
|
The lowest SpO2 (%) during general anesthesia induction (from a base period to the mechanical ventilation).
| 20 minutes |
| Preoxygenation Comfort | The subjective comfort of the patient during the preoxygenation, expressed with a 0-5 scale at Post Anesthesia Care Unit (PACU) discharge. | 6 hours |
| 28203758 | Background | Ang KS, Green A, Ramaswamy KK, Frerk C. Preoxygenation using the Optiflow system. Br J Anaesth. 2017 Mar 1;118(3):463-464. doi: 10.1093/bja/aex016. No abstract available. |
| 28072931 | Background | White LD, Melhuish TM, White LK, Wallace LA. Apnoeic oxygenation during intubation: a systematic review and meta-analysis. Anaesth Intensive Care. 2017 Jan;45(1):21-27. doi: 10.1177/0310057X1704500104. |
| 28035669 | Background | Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30. |
| 27933345 | Background | Bauchmuller KB, Glossop AJ, De Jong A, Jaber S. Combining high-flow nasal cannula oxygen and non-invasive ventilation for pre-oxygenation in the critically ill: is a double-pronged approach warranted? : Discussion on article "Apnoeic oxygenation via high-flow nasal cannula oxygen combined with non-invasive ventilation preoxygenation for intubation in hypoxaemic patients in the intensive care unit: the single-centre, blinded, randomised controlled OPTINIV trial". Intensive Care Med. 2017 Feb;43(2):288-290. doi: 10.1007/s00134-016-4635-6. Epub 2016 Dec 8. No abstract available. |
| 27730283 | Background | Jaber S, Monnin M, Girard M, Conseil M, Cisse M, Carr J, Mahul M, Delay JM, Belafia F, Chanques G, Molinari N, De Jong A. Apnoeic oxygenation via high-flow nasal cannula oxygen combined with non-invasive ventilation preoxygenation for intubation in hypoxaemic patients in the intensive care unit: the single-centre, blinded, randomised controlled OPTINIV trial. Intensive Care Med. 2016 Dec;42(12):1877-1887. doi: 10.1007/s00134-016-4588-9. Epub 2016 Oct 11. |
| 27546740 | Background | Doyle AJ, Stolady D, Mariyaselvam M, Wijewardena G, Gent E, Blunt M, Young P. Preoxygenation and apneic oxygenation using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for emergency intubation. J Crit Care. 2016 Dec;36:8-12. doi: 10.1016/j.jcrc.2016.06.011. Epub 2016 Jun 23. |
| 23271822 | Background | Ward JJ. High-flow oxygen administration by nasal cannula for adult and perinatal patients. Respir Care. 2013 Jan;58(1):98-122. doi: 10.4187/respcare.01941. |
| 21908497 | Background | Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9. |
| 19846404 | Background | Parke R, McGuinness S, Eccleston M. Nasal high-flow therapy delivers low level positive airway pressure. Br J Anaesth. 2009 Dec;103(6):886-90. doi: 10.1093/bja/aep280. Epub 2009 Oct 20. |
| 29105056 | Background | Kostic P, LoMauro A, Larsson A, Hedenstierna G, Frykholm P, Aliverti A. Specific anesthesia-induced lung volume changes from induction to emergence: a pilot study. Acta Anaesthesiol Scand. 2018 Mar;62(3):282-292. doi: 10.1111/aas.13026. Epub 2017 Nov 3. |
| 28099321 | Background | Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg. 2017 Feb;124(2):507-517. doi: 10.1213/ANE.0000000000001589. |
| 27015801 | Background | Fraser JF, Spooner AJ, Dunster KR, Anstey CM, Corley A. Nasal high flow oxygen therapy in patients with COPD reduces respiratory rate and tissue carbon dioxide while increasing tidal and end-expiratory lung volumes: a randomised crossover trial. Thorax. 2016 Aug;71(8):759-61. doi: 10.1136/thoraxjnl-2015-207962. Epub 2016 Mar 25. |
| 24738713 | Background | Harbut P, Gozdzik W, Stjernfalt E, Marsk R, Hesselvik JF. Continuous positive airway pressure/pressure support pre-oxygenation of morbidly obese patients. Acta Anaesthesiol Scand. 2014 Jul;58(6):675-80. doi: 10.1111/aas.12317. Epub 2014 Apr 16. |
| 23337480 | Background | Nakahashi S, Gando S, Ishikawa T, Wada T, Yanagida Y, Kubota N, Uegaki S, Hayakawa M, Sawamura A. Effectiveness of end-expiratory lung volume measurements during the lung recruitment maneuver for patients with atelectasis. J Crit Care. 2013 Aug;28(4):534.e1-5. doi: 10.1016/j.jcrc.2012.11.003. Epub 2013 Jan 18. |
| 18931236 | Background | Delay JM, Sebbane M, Jung B, Nocca D, Verzilli D, Pouzeratte Y, Kamel ME, Fabre JM, Eledjam JJ, Jaber S. The effectiveness of noninvasive positive pressure ventilation to enhance preoxygenation in morbidly obese patients: a randomized controlled study. Anesth Analg. 2008 Nov;107(5):1707-13. doi: 10.1213/ane.0b013e318183909b. |
| 16627862 | Background | Baillard C, Fosse JP, Sebbane M, Chanques G, Vincent F, Courouble P, Cohen Y, Eledjam JJ, Adnet F, Jaber S. Noninvasive ventilation improves preoxygenation before intubation of hypoxic patients. Am J Respir Crit Care Med. 2006 Jul 15;174(2):171-7. doi: 10.1164/rccm.200509-1507OC. Epub 2006 Apr 20. |
| 12594585 | Background | van Genderingen HR, van Vught AJ, Jansen JR. Estimation of regional lung volume changes by electrical impedance pressures tomography during a pressure-volume maneuver. Intensive Care Med. 2003 Feb;29(2):233-40. doi: 10.1007/s00134-002-1586-x. Epub 2002 Dec 14. |
| 12528020 | Background | Hinz J, Hahn G, Neumann P, Sydow M, Mohrenweiser P, Hellige G, Burchardi H. End-expiratory lung impedance change enables bedside monitoring of end-expiratory lung volume change. Intensive Care Med. 2003 Jan;29(1):37-43. doi: 10.1007/s00134-002-1555-4. Epub 2002 Nov 20. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |