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

NCT03615417 | Completed

• 3 other identifiers: SRB-201712-161B406201834736P2018/067
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preoxygenation; Anesthesia; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time of safe apnea

  20 minutes

• Lowest SpO2

  20 minutes

• Preoxygenation Comfort

  6 hours

Study Arms (2)

HFNC - High Flow Nasal Cannula

EXPERIMENTAL

Participants are preoxygenated by High Flow Nasal Cannula (HFNC) OptiFlow.

Device: High Flow Nasal Cannula (HFNC)

FM - FaceMask

ACTIVE COMPARATOR

Participants are preoxygenated by standard anesthesia FaceMask.

Device: Standard anesthesia FaceMask (FM)

Interventions

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.

Also known as: THRIVE, OptiFlow

HFNC - High Flow Nasal Cannula

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.

FM - FaceMask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgery with the need for general anesthesia with muscle relaxation
• ASA (American Society of Anesthesiologists) physical status score II-III
• BMI \> 35

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme University Hospital

Brussels, 1070, Belgium

Location

Related Publications (20)

• 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.

  PMID: 29144160 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.

  PMID: 29071075 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.

  PMID: 28203758 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.

  PMID: 28072931 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.

  PMID: 28035669 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.

  PMID: 27933345 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.

  PMID: 27730283 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.

  PMID: 27546740 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.

  PMID: 23271822 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.

  PMID: 21908497 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.

  PMID: 19846404 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.

  PMID: 29105056 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.

  PMID: 28099321 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.

  PMID: 27015801 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.

  PMID: 24738713 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.

  PMID: 23337480 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.

  PMID: 18931236 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.

  PMID: 16627862 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.

  PMID: 12594585 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.

  PMID: 12528020 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Francesco Ricottilli, MD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Department of Anesthesiology

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: April 19, 2018
• Primary Completion: September 7, 2018
• Study Completion: September 7, 2018
• Last Updated: November 19, 2018

Record last verified: 2018-11

Locations

BE (1)