Clinical trial NCT03696563: FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
Official title: Automated Administration of Oxygen Using the FreeO2 Device in Ambulances for COPD and Trauma Patients: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD Exacerbation
Trauma
Keywords: prehospital
oxygen therapy
automation
trauma
COPD
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: The Ottawa Hospital
name: Ottawa Hospital Research Institute
First posted: 2018-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This will be a single centered prehospital multi-period cluster crossover feasibility trial
Primary purpose: TREATMENT

Brief summary: Evaluation of automated oxygen titration in comparison with manual adjustment oxygen in the out-of-hospital setting by paramedics.

Detailed description: It is a single center study in Ottawa, Ontario Canada.

This will be a single centered prehospital multi-period cluster crossover feasibility trial, enrolling patients in Ottawa, Ontario, who are treated by paramedics from the Ottawa Paramedic Service, who have been trained in the use of the automated oxygen delivery device. We will be using the FreeO2 device. Patients requiring oxygen therapy during prehospital transportation will be enrolled. No randomization will occur within this single centered feasibility study

Patients requiring oxygen therapy during the prehospital transportation will be enrolled and will be included as soon as they are placed into the ambulance, until handover and transfer of care at receiving hospital.

In both groups, SpO2 will be collected continuously every second with FreeO2 monitoring, in addition to the collection of vital signs carried out by the staff according to the standards.

Eligibility criteria: Inclusion Criteria:

COPD patient:

1. Known or suspected acute exacerbation of COPD. Acute exacerbation is defined by worsening of the respiratory condition for less than 2 weeks. Suspected COPD is defined by patients of at least 30 years old with respiratory symptoms with a past or current smoking history of at least 10 pack years, or
2. Able to measure SpO2 via pulse oximetry

Trauma patient:

I) Trauma: patients who sustain any trauma (minor or major), II) Able to measure SpO2 via pulse oximetry

Exclusion Criteria:

* Inclusion in another study not allowing the co-enrollment
* Pregnancy
* Age \<18 years
* Prehospital Invasive or non-invasive mechanical ventilation
* Meeting high concentration oxygen administration injury or condition (as per BLS-PCS Oxygen Therapy Standard (Version 3.0), s(2)a-f).

Primary outcomes:
measure: Feasibility of the study design - REB approval
timeFrame: Date of REB submission to date of REB approval, target: until 3 months (90 days) from REB submission
measure: Feasibility of the study design - initiate the clinical trial
timeFrame: Target until 3 months (90 days) from REB approval
measure: Feasibility of the study design - Evaluation of data collection tool
timeFrame: through study completion, an average of 1 year
measure: Feasibility of the study design - study protocol compliance
timeFrame: through study completion,an average of 1 year
measure: Feasibility of the study design - Paramedics survey
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Oxygenation - Total Time in the target zone SpO2
timeFrame: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
measure: Oxygenation - Total time with hyperoxia
timeFrame: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
measure: Oxygenation - Total time with hypoxemia
timeFrame: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
measure: The oxygentherapy complication- PaCO2
timeFrame: Day 1- On The first ABG or capillary blood gases after hospital admission
measure: The oxygentherapy complication - respiratory acidosis
timeFrame: Day 1- On The first ABG or capillary blood gases after hospital admission
measure: The rate of patients without oxygen at the end of the transportation
timeFrame: Day 1 - At the end of the transportation (at the exit from the ambulance)
measure: Outcome data - NIV
timeFrame: through study completion, an average of 1 year
measure: Outcome data - ICU admission
timeFrame: through study completion, an average of 1 year
measure: Outcome data - Death
timeFrame: During hospital stay - hospital admission through study completion or until death if occured, up to 8 weeks
measure: Outcome data
timeFrame: Length of hospital stay measured in calendar days, hospital admission through study completion, up to 8 weeks
measure: The oxygen consumption during the pre-hospital transport
timeFrame: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance),
Other outcomes:
Locations:
Study officials:
affiliation: Regional Paramedic Program for Eastern Ontario, Ottawa Hospital Research Institute
name: Michael Austin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johannigman JA, Branson R, Lecroy D, Beck G. Autonomous control of inspired oxygen concentration during mechanical ventilation of the critically injured trauma patient. J Trauma. 2009 Feb;66(2):386-92. doi: 10.1097/TA.0b013e318197a4bb.
citation: Johannigman JA, Muskat P, Barnes S, Davis K Jr, Beck G, Branson RD. Autonomous control of oxygenation. J Trauma. 2008 Apr;64(4 Suppl):S295-301. doi: 10.1097/TA.0b013e31816bce54. No abstract available.
citation: Higuchi S, Fukushi G, Baba T, Sasaki D, Yoshida Y. New method of testing for carbohydrate absorption in man. Xylose and sucrose absorption; effects of sucrase inhibition. Dig Dis Sci. 1986 Apr;31(4):369-75. doi: 10.1007/BF01311671.
citation: O'Driscoll BR, Howard LS, Davison AG; British Thoracic Society. BTS guideline for emergency oxygen use in adult patients. Thorax. 2008 Oct;63 Suppl 6:vi1-68. doi: 10.1136/thx.2008.102947. No abstract available.
citation: Branson RD, Johannigman JA. Pre-hospital oxygen therapy. Respir Care. 2013 Jan;58(1):86-97. doi: 10.4187/respcare.02251.
citation: Hale KE, Gavin C, O'Driscoll BR. Audit of oxygen use in emergency ambulances and in a hospital emergency department. Emerg Med J. 2008 Nov;25(11):773-6. doi: 10.1136/emj.2008.059287.
citation: Aubier M, Murciano D, Fournier M, Milic-Emili J, Pariente R, Derenne JP. Central respiratory drive in acute respiratory failure of patients with chronic obstructive pulmonary disease. Am Rev Respir Dis. 1980 Aug;122(2):191-9. doi: 10.1164/arrd.1980.122.2.191.
citation: Aubier M, Murciano D, Milic-Emili J, Touaty E, Daghfous J, Pariente R, Derenne JP. Effects of the administration of O2 on ventilation and blood gases in patients with chronic obstructive pulmonary disease during acute respiratory failure. Am Rev Respir Dis. 1980 Nov;122(5):747-54. doi: 10.1164/arrd.1980.122.5.747.
citation: Dunn WF, Nelson SB, Hubmayr RD. Oxygen-induced hypercarbia in obstructive pulmonary disease. Am Rev Respir Dis. 1991 Sep;144(3 Pt 1):526-30. doi: 10.1164/ajrccm/144.3_Pt_1.526.
citation: Sassoon CS, Hassell KT, Mahutte CK. Hyperoxic-induced hypercapnia in stable chronic obstructive pulmonary disease. Am Rev Respir Dis. 1987 Apr;135(4):907-11. doi: 10.1164/arrd.1987.135.4.907.
citation: DAVIES CE, MACKINNON J. Neurological effects of oxygen in chronic cor pulmonale. Lancet. 1949 Nov 12;2(6585):883-5, illust. doi: 10.1016/s0140-6736(49)91459-2. No abstract available.
citation: Wiener AS, Cioffi AF. A group B analogue of subgroup A 3. Am J Clin Pathol. 1972 Dec;58(6):693-7. doi: 10.1093/ajcp/58.6.693. No abstract available.
citation: Murphy R, Mackway-Jones K, Sammy I, Driscoll P, Gray A, O'Driscoll R, O'Reilly J, Niven R, Bentley A, Brear G, Kishen R. Emergency oxygen therapy for the breathless patient. Guidelines prepared by North West Oxygen Group. Emerg Med J. 2001 Nov;18(6):421-3. doi: 10.1136/emj.18.6.421. No abstract available.
citation: Pauwels RA, Buist AS, Calverley PM, Jenkins CR, Hurd SS; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. Am J Respir Crit Care Med. 2001 Apr;163(5):1256-76. doi: 10.1164/ajrccm.163.5.2101039. No abstract available.
citation: Kettel LJ, Diener CF, Morse JO, Stein HF, Burrows B. Treatment of acute respiratory acidosis in chronic obstructive lung disease. JAMA. 1971 Sep 13;217(11):1503-8. No abstract available.
citation: Warren PM, Flenley DC, Millar JS, Avery A. Respiratory failure revisited: acute exacerbations of chronic bronchitis between 1961-68 and 1970-76. Lancet. 1980 Mar 1;1(8166):467-70. doi: 10.1016/s0140-6736(80)91008-9.
citation: Scales DC, Adhikari NK. Lost in (knowledge) translation: "All breakthrough, no follow through"? Crit Care Med. 2008 May;36(5):1654-5. doi: 10.1097/CCM.0b013e3181701525. No abstract available.
citation: Bateman NT, Leach RM. ABC of oxygen. Acute oxygen therapy. BMJ. 1998 Sep 19;317(7161):798-801. doi: 10.1136/bmj.317.7161.798. No abstract available.
citation: DeWitt DS, Prough DS. Blast-induced brain injury and posttraumatic hypotension and hypoxemia. J Neurotrauma. 2009 Jun;26(6):877-87. doi: 10.1089/neu.2007.0439.
citation: Galatius-Jensen S, Hansen J, Rasmussen V, Bildsoe J, Therboe M, Rosenberg J. Nocturnal hypoxaemia after myocardial infarction: association with nocturnal myocardial ischaemia and arrhythmias. Br Heart J. 1994 Jul;72(1):23-30. doi: 10.1136/hrt.72.1.23.
citation: Farquhar H, Weatherall M, Wijesinghe M, Perrin K, Ranchord A, Simmonds M, Beasley R. Systematic review of studies of the effect of hyperoxia on coronary blood flow. Am Heart J. 2009 Sep;158(3):371-7. doi: 10.1016/j.ahj.2009.05.037. Epub 2009 Jul 15.
citation: Floyd TF, Ratcliffe SJ, Detre JA, Woo YJ, Acker MA, Bavaria JE, Resh BF, Pochettino AA, Eckenhoff RA. Integrity of the cerebral blood-flow response to hyperoxia after cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2007 Apr;21(2):212-7. doi: 10.1053/j.jvca.2006.02.017. Epub 2006 May 18.
citation: Floyd TF, Clark JM, Gelfand R, Detre JA, Ratcliffe S, Guvakov D, Lambertsen CJ, Eckenhoff RG. Independent cerebral vasoconstrictive effects of hyperoxia and accompanying arterial hypocapnia at 1 ATA. J Appl Physiol (1985). 2003 Dec;95(6):2453-61. doi: 10.1152/japplphysiol.00303.2003. Epub 2003 Aug 22.
citation: Johnston AJ, Steiner LA, Gupta AK, Menon DK. Cerebral oxygen vasoreactivity and cerebral tissue oxygen reactivity. Br J Anaesth. 2003 Jun;90(6):774-86. doi: 10.1093/bja/aeg104.
citation: Ronning OM, Guldvog B. Should stroke victims routinely receive supplemental oxygen? A quasi-randomized controlled trial. Stroke. 1999 Oct;30(10):2033-7. doi: 10.1161/01.str.30.10.2033.
citation: Brenner M, Stein D, Hu P, Kufera J, Wooford M, Scalea T. Association between early hyperoxia and worse outcomes after traumatic brain injury. Arch Surg. 2012 Nov;147(11):1042-6. doi: 10.1001/archsurg.2012.1560.
citation: Rincon F, Kang J, Maltenfort M, Vibbert M, Urtecho J, Athar MK, Jallo J, Pineda CC, Tzeng D, McBride W, Bell R. Association between hyperoxia and mortality after stroke: a multicenter cohort study. Crit Care Med. 2014 Feb;42(2):387-96. doi: 10.1097/CCM.0b013e3182a27732.
citation: Rincon F, Kang J, Vibbert M, Urtecho J, Athar MK, Jallo J. Significance of arterial hyperoxia and relationship with case fatality in traumatic brain injury: a multicentre cohort study. J Neurol Neurosurg Psychiatry. 2014 Jul;85(7):799-805. doi: 10.1136/jnnp-2013-305505. Epub 2013 Jun 21.
citation: Cameron L, Pilcher J, Weatherall M, Beasley R, Perrin K. The risk of serious adverse outcomes associated with hypoxaemia and hyperoxaemia in acute exacerbations of COPD. Postgrad Med J. 2012 Dec;88(1046):684-9. doi: 10.1136/postgradmedj-2012-130809. Epub 2012 Sep 12.
citation: Lellouche F, Bouchard PA, Simard S, L'Her E, Wysocki M. Evaluation of fully automated ventilation: a randomized controlled study in post-cardiac surgery patients. Intensive Care Med. 2013 Mar;39(3):463-71. doi: 10.1007/s00134-012-2799-2. Epub 2013 Jan 22.
citation: Lellouche F, Mancebo J, Jolliet P, Roeseler J, Schortgen F, Dojat M, Cabello B, Bouadma L, Rodriguez P, Maggiore S, Reynaert M, Mersmann S, Brochard L. A multicenter randomized trial of computer-driven protocolized weaning from mechanical ventilation. Am J Respir Crit Care Med. 2006 Oct 15;174(8):894-900. doi: 10.1164/rccm.200511-1780OC. Epub 2006 Jul 13.
citation: Denniston AK, O'Brien C, Stableforth D. The use of oxygen in acute exacerbations of chronic obstructive pulmonary disease: a prospective audit of pre-hospital and hospital emergency management. Clin Med (Lond). 2002 Sep-Oct;2(5):449-51. doi: 10.7861/clinmedicine.2-5-449.
citation: Joosten SA, Koh MS, Bu X, Smallwood D, Irving LB. The effects of oxygen therapy in patients presenting to an emergency department with exacerbation of chronic obstructive pulmonary disease. Med J Aust. 2007 Mar 5;186(5):235-8. doi: 10.5694/j.1326-5377.2007.tb00879.x.
citation: Plant PK, Owen JL, Elliott MW. One year period prevalence study of respiratory acidosis in acute exacerbations of COPD: implications for the provision of non-invasive ventilation and oxygen administration. Thorax. 2000 Jul;55(7):550-4. doi: 10.1136/thorax.55.7.550.
citation: Austin MA, Wills KE, Blizzard L, Walters EH, Wood-Baker R. Effect of high flow oxygen on mortality in chronic obstructive pulmonary disease patients in prehospital setting: randomised controlled trial. BMJ. 2010 Oct 18;341:c5462. doi: 10.1136/bmj.c5462.
citation: Wijesinghe M, Perrin K, Ranchord A, Simmonds M, Weatherall M, Beasley R. Routine use of oxygen in the treatment of myocardial infarction: systematic review. Heart. 2009 Mar;95(3):198-202. doi: 10.1136/hrt.2008.148742. Epub 2008 Aug 15.
citation: Lellouche F, L'her E. Automated oxygen flow titration to maintain constant oxygenation. Respir Care. 2012 Aug;57(8):1254-62. doi: 10.4187/respcare.01343. Epub 2012 Feb 17.