Non Invasive Ventilation Combined to High Flow Nasal Cannula Oxygen for Preoxygenation of Hypoxemic ICU Patients

NCT02530957 | Completed

• 2 other identifiers: 95432015-A00708-41
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Tracheal intubation is a challenging procedure in Intensive Care Unit (ICU), associated with severe life threatening complications. To decrease these complications, preoxygenation is recommended. Non invasive ventilation (NIV) increase effectiveness of preoxygenation, applying a positive end expiratory pressure (PEEP). High-flow nasal cannula oxygen (HFNC) improves oxygenation by increasing end-expiratory lung volume and has a potential of apneic oxygenation. The association of NIV and HFNC for preoxygenation in hypoxemic ICU patients has never been evaluated. The aim of this study is to determine if HFNC combined to NIV could have therapeutic advantages over NIV alone for preoxygenation in the ICU patients intubated for hypoxemic acute respiratory failure.

Conditions

Intubation Intraesophageal

Keywords

Intubation; Preoxygenation; Complications; Non invasive ventilation; High flow nasal cannula

Outcome Measures

Primary Outcomes (1)

• Lowest oxygen saturation

  1 years

Secondary Outcomes (1)

• Number of complications related to intubation

  1 years

Study Arms (2)

Interventional

EXPERIMENTAL

In the interventional group, a preoxygenation by NIV (PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100%) combined to HNFC (Flow of 60L/min, FiO2 = 100%) is applied.

Device: Non invasive ventilation + High flow nasal cannula oxygen

Reference

OTHER

In the reference group, a preoxygenation by NIV only (PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100%) is applied.

Device: Non invasive ventilation

Interventions

Non invasive ventilation + High flow nasal cannula oxygen DEVICE

In the interventional group, a preoxygenation by NIV (venturi mask of Intersurgical or Respironics mask) with PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100% and combined to HNFC (nasal cannula oxygen of Fisher and Paykel) with Flow of 60L/min, FiO2 = 100% is applied.

Interventional

Non invasive ventilation DEVICE

In the reference group, a preoxygenation by NIV (venturi mask of Intersurgical or Respironics mask) only, with PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100% is applied.

Reference

Eligibility Criteria

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

You may qualify if:

• Adult hypoxemic patients

You may not qualify if:

• non adult patients (age \<18 years)
• pregnant woman
• protected persons
• Patient intubated in case of cardio circulatory arrest
• Patient with nasopharyngeal obstacle contraindicating the use of HNFC

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Centre Hospitalier Universitaire Montpellier, Saint Eloi

Montpellier, Languedoc-Roussillon, 34295, France

Location

Related Publications (29)

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  PMID: 23348979 BACKGROUND

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  PMID: 16850003 BACKGROUND

• De Jong A, Jung B, Jaber S. Intubation in the ICU: we could improve our practice. Crit Care. 2014 Mar 18;18(2):209. doi: 10.1186/cc13776. No abstract available.

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• De Jong A, Futier E, Millot A, Coisel Y, Jung B, Chanques G, Baillard C, Jaber S. How to preoxygenate in operative room: healthy subjects and situations "at risk". Ann Fr Anesth Reanim. 2014 Jul-Aug;33(7-8):457-61. doi: 10.1016/j.annfar.2014.08.001. Epub 2014 Aug 29.

  PMID: 25168301 BACKGROUND

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  PMID: 16627862 BACKGROUND

• Jaber S, Michelet P, Chanques G. Role of non-invasive ventilation (NIV) in the perioperative period. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):253-65. doi: 10.1016/j.bpa.2010.02.007.

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• Vourc'h M, Asfar P, Volteau C, Bachoumas K, Clavieras N, Egreteau PY, Asehnoune K, Mercat A, Reignier J, Jaber S, Prat G, Roquilly A, Brule N, Villers D, Bretonniere C, Guitton C. High-flow nasal cannula oxygen during endotracheal intubation in hypoxemic patients: a randomized controlled clinical trial. Intensive Care Med. 2015 Sep;41(9):1538-48. doi: 10.1007/s00134-015-3796-z. Epub 2015 Apr 14.

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  PMID: 25479117 BACKGROUND

• Chanques G, Riboulet F, Molinari N, Carr J, Jung B, Prades A, Galia F, Futier E, Constantin JM, Jaber S. Comparison of three high flow oxygen therapy delivery devices: a clinical physiological cross-over study. Minerva Anestesiol. 2013 Dec;79(12):1344-55. Epub 2013 Jul 15.

  PMID: 23857440 BACKGROUND

• Chanques G, Jaber S. [Unexpected progress of an old intensive care therapy, oxygen: towards more comfort and less mechanical ventilation...]. Rev Mal Respir. 2013 Oct;30(8):605-8. doi: 10.1016/j.rmr.2013.07.006. Epub 2013 Aug 27. No abstract available. French.

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• Hedenstierna G, Rothen HU. Atelectasis formation during anesthesia: causes and measures to prevent it. J Clin Monit Comput. 2000;16(5-6):329-35. doi: 10.1023/a:1011491231934.

  PMID: 12580216 BACKGROUND

• Hedenstierna G, Edmark L. The effects of anesthesia and muscle paralysis on the respiratory system. Intensive Care Med. 2005 Oct;31(10):1327-35. doi: 10.1007/s00134-005-2761-7. Epub 2005 Aug 16.

  PMID: 16132894 BACKGROUND

• Kolettas A, Grosomanidis V, Kolettas V, Zarogoulidis P, Tsakiridis K, Katsikogiannis N, Tsiouda T, Kiougioumtzi I, Machairiotis N, Drylis G, Kesisis G, Beleveslis T, Zarogoulidis K. Influence of apnoeic oxygenation in respiratory and circulatory system under general anaesthesia. J Thorac Dis. 2014 Mar;6 Suppl 1(Suppl 1):S116-45. doi: 10.3978/j.issn.2072-1439.2014.01.17.

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• Engstrom J, Hedenstierna G, Larsson A. Pharyngeal oxygen administration increases the time to serious desaturation at intubation in acute lung injury: an experimental study. Crit Care. 2010;14(3):R93. doi: 10.1186/cc9027. Epub 2010 May 24.

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• Griesdale DE, Bosma TL, Kurth T, Isac G, Chittock DR. Complications of endotracheal intubation in the critically ill. Intensive Care Med. 2008 Oct;34(10):1835-42. doi: 10.1007/s00134-008-1205-6. Epub 2008 Jul 5.

  PMID: 18604519 BACKGROUND

• Jaber S, Jung B, Corne P, Sebbane M, Muller L, Chanques G, Verzilli D, Jonquet O, Eledjam JJ, Lefrant JY. An intervention to decrease complications related to endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Intensive Care Med. 2010 Feb;36(2):248-55. doi: 10.1007/s00134-009-1717-8. Epub 2009 Nov 17.

  PMID: 19921148 BACKGROUND

• De Jong A, Clavieras N, Conseil M, Coisel Y, Moury PH, Pouzeratte Y, Cisse M, Belafia F, Jung B, Chanques G, Molinari N, Jaber S. Implementation of a combo videolaryngoscope for intubation in critically ill patients: a before-after comparative study. Intensive Care Med. 2013 Dec;39(12):2144-52. doi: 10.1007/s00134-013-3099-1. Epub 2013 Sep 18.

  PMID: 24045887 BACKGROUND

• Jung B, Clavieras N, Nougaret S, Molinari N, Roquilly A, Cisse M, Carr J, Chanques G, Asehnoune K, Jaber S. Effects of etomidate on complications related to intubation and on mortality in septic shock patients treated with hydrocortisone: a propensity score analysis. Crit Care. 2012 Nov 21;16(6):R224. doi: 10.1186/cc11871.

  PMID: 23171852 BACKGROUND

• Futier E, Constantin JM, Pelosi P, Chanques G, Massone A, Petit A, Kwiatkowski F, Bazin JE, Jaber S. Noninvasive ventilation and alveolar recruitment maneuver improve respiratory function during and after intubation of morbidly obese patients: a randomized controlled study. Anesthesiology. 2011 Jun;114(6):1354-63. doi: 10.1097/ALN.0b013e31821811ba.

  PMID: 21478734 BACKGROUND

• Chanques G, Constantin JM, Sauter M, Jung B, Sebbane M, Verzilli D, Lefrant JY, Jaber S. Discomfort associated with underhumidified high-flow oxygen therapy in critically ill patients. Intensive Care Med. 2009 Jun;35(6):996-1003. doi: 10.1007/s00134-009-1456-x. Epub 2009 Mar 18.

  PMID: 19294365 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

• De Jong A, Molinari N, Conseil M, Coisel Y, Pouzeratte Y, Belafia F, Jung B, Chanques G, Jaber S. Video laryngoscopy versus direct laryngoscopy for orotracheal intubation in the intensive care unit: a systematic review and meta-analysis. Intensive Care Med. 2014 May;40(5):629-39. doi: 10.1007/s00134-014-3236-5. Epub 2014 Feb 21.

  PMID: 24556912 BACKGROUND

• Jaber S, De Jong A, Castagnoli A, Futier E, Chanques G. Non-invasive ventilation after surgery. Ann Fr Anesth Reanim. 2014 Jul-Aug;33(7-8):487-91. doi: 10.1016/j.annfar.2014.07.742. Epub 2014 Aug 29.

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• Bourgain JL, Jaber S. [Preoxygenation: conditions of success]. Ann Fr Anesth Reanim. 2010 Mar;29(3):187-8. doi: 10.1016/j.annfar.2009.12.027. Epub 2010 Jan 27. No abstract available. French.

  PMID: 20106629 BACKGROUND

• De Jong A, Baranwal AK, Jaber S. Predictors of difficult intubation in ICU: are children and adults alike? Intensive Care Med. 2014 Nov;40(11):1769-71. doi: 10.1007/s00134-014-3429-y. Epub 2014 Aug 28. No abstract available.

  PMID: 25164393 BACKGROUND

• De Jong A, Jaber S. [Intubation in intensive care medicine: we could improve our practices!]. Ann Fr Anesth Reanim. 2014 May;33(5):293-4. doi: 10.1016/j.annfar.2014.03.017. Epub 2014 May 9. No abstract available. French.

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• Mort TC. Preoxygenation in critically ill patients requiring emergency tracheal intubation. Crit Care Med. 2005 Nov;33(11):2672-5. doi: 10.1097/01.ccm.0000187131.67594.9e.

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• Mort TC, Waberski BH, Clive J. Extending the preoxygenation period from 4 to 8 mins in critically ill patients undergoing emergency intubation. Crit Care Med. 2009 Jan;37(1):68-71. doi: 10.1097/CCM.0b013e318192845e.

  PMID: 19050620 BACKGROUND

• Jaber S, Molinari N, De Jong A. New method of preoxygenation for orotracheal intubation in patients with hypoxaemic acute respiratory failure in the intensive care unit, non-invasive ventilation combined with apnoeic oxygenation by high flow nasal oxygen: the randomised OPTINIV study protocol. BMJ Open. 2016 Aug 12;6(8):e011298. doi: 10.1136/bmjopen-2016-011298.

  PMID: 27519921 DERIVED

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Samir JABER, M.D, Ph.D

  Departement of Unit Care in Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 21, 2015
• Study Start: June 23, 2015
• Primary Completion: February 28, 2016
• Study Completion: March 17, 2016
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

FR (1)