High-Flow Nasal Cannula (HFNC) Preoxygenation in Obese Patients Undergoing General Anesthesia

Obesity Clinical Trial

Official title:

Effectiveness of High-Flow Nasal Cannula (HFNC) Preoxygenation in Obese Patients Undergoing General Anesthesia: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615417
• Other study ID #: SRB-201712-161
• Secondary ID: B406201834736P20
• Status: Completed
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: September 7, 2018

Study information

• Verified date: November 2018
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 7, 2018
• Est. primary completion date: September 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Surgery with the need for general anesthesia with muscle relaxation

• ASA (American Society of Anesthesiologists) physical status score II-III

• BMI > 35

Exclusion Criteria:

• Severe respiratory disease (acute respiratory failure, Chronic obstructive pulmonary disease COPD, parenchymal pneumopathies,...)

• Severe nasal pathology (malformation, stenosis)

• Criteria or previous difficult intubation

• BMI > 50

• Chest circumference > 150cm

• Implanted electronic device (pacemaker, neurostimulator, ...)

• Pregnancy

Related Conditions & MeSH terms

• Anesthesia
• Obesity
• Preoxygenation

Intervention

Device:
• High Flow Nasal Cannula (HFNC)
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.
• Standard anesthesia FaceMask (FM)
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.

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (20)

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. — View Citation

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. Epub 2006 Apr 20. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Harbut P, Gozdzik W, Stjernfält 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. — View Citation

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. Epub 2002 Nov 20. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2002 Dec 14. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Lowest SpO2	The lowest SpO2 (%) during general anesthesia induction (from a base period to the mechanical ventilation).	20 minutes
Secondary	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