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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03696563
Other study ID # 20180570-01H
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2021
Est. completion date June 2022

Study information

Verified date November 2020
Source Laval University
Contact Michael Austin
Phone 613-737-7228
Email maustin@toh.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Automated oxygen administration - FreeO2
The adjustment of the oxygen flow will be made by the FreeO2 system, an automated titration of oxygen flow every second to reach the SpO2 target. The SpO2 target will be set at 90% in COPD patients and 94% in trauma patients.
Other:
Standard administration of oxygen flow
The flow of oxygen will be administered according to the usual protocol during the transport and until transfer to the emergency departement.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
François Lellouche Ottawa Hospital Research Institute, The Ottawa Hospital

References & Publications (37)

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. — View 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. — View 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. — View Citation

Bateman NT, Leach RM. ABC of oxygen. Acute oxygen therapy. BMJ. 1998 Sep 19;317(7161):798-801. Review. — View Citation

Branson RD, Johannigman JA. Pre-hospital oxygen therapy. Respir Care. 2013 Jan;58(1):86-97. doi: 10.4187/respcare.02251. Review. — View 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. — View 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. Review. — View Citation

DAVIES CE, MACKINNON J. Neurological effects of oxygen in chronic cor pulmonale. Lancet. 1949 Nov 12;2(6585):883-5, illust. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. Epub 2003 Aug 22. — View 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. Epub 2006 May 18. — View Citation

Galatius-Jensen S, Hansen J, Rasmussen V, Bildsøe 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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 — View 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. — View 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. Erratum in: Thorax. 2009 Jan;64(1):91. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Rønning OM, Guldvog B. Should stroke victims routinely receive supplemental oxygen? A quasi-randomized controlled trial. Stroke. 1999 Oct;30(10):2033-7. — View 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. — View 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. — View 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. — View Citation

Wiener AS, Cioffi AF. A group B analogue of subgroup A 3 . Am J Clin Pathol. 1972 Dec;58(6):693-7. — View 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. Review. — View Citation

* Note: There are 37 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of the study design - REB approval Time to REB approval for single site time to REB approval for single site define by below 3 months (90 days) from REB submission, time to readiness to initiate the clinical trial after REB approval - below 3 months (90 days) from REB approval, evaluation of data collection tool - 100% of data captured in >90% case at hospital discharge (until day 28), Survey responses from Paramedics - At the end of the transportation day Date of REB submission to date of REB approval, target: until 3 months (90 days) from REB submission
Primary Feasibility of the study design - initiate the clinical trial Time to readiness to initiate the clinical trial Target until 3 months (90 days) from REB approval
Primary Feasibility of the study design - Evaluation of data collection tool target: 100% of data captured in >90% cases through study completion, an average of 1 year
Primary Feasibility of the study design - study protocol compliance Target of 80% of compliance for protocol intervention/control group through study completion,an average of 1 year
Primary Feasibility of the study design - Paramedics survey A survey will be complete by Paramedics at the end of day of transportation (day 1); the target response rate is 75% of case. through study completion, an average of 1 year
Secondary Oxygenation - Total Time in the target zone SpO2 Percentage of time spent in the target zone SpO2
90±2% in the COPD population (in the range of 88 to 92%)
94±2% in the trauma population (in the range of 92 to 96%)
Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
Secondary Oxygenation - Total time with hyperoxia Percentage of time spent in hyperoxia (SpO2 > 94% in COPD patients and SpO2 >98% in trauma patients) Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
Secondary Oxygenation - Total time with hypoxemia Percentage of time spent in the target zone SpO2
- % of time with hypoxemia (SpO2<86% in COPD patients and SpO2 <90% in trauma patients)
Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
Secondary The oxygentherapy complication- PaCO2 -Evaluation of level of PaCO2 on the first ABG at ED or ICU admission (when available) Day 1- On The first ABG or capillary blood gases after hospital admission
Secondary The oxygentherapy complication - respiratory acidosis -Evaluation of the rate of respiratory acidosis (pH<7.35 and PaCO2>45mmHg) after hospital admission Day 1- On The first ABG or capillary blood gases after hospital admission
Secondary The rate of patients without oxygen at the end of the transportation Rate of patient weaned of oxygen at the end of the transportation Day 1 - At the end of the transportation (at the exit from the ambulance)
Secondary Outcome data - NIV The rate of NIV use during lenght of stay in hospital through study completion, an average of 1 year
Secondary Outcome data - ICU admission The rate of ICU admission during lenght of stay in hospital through study completion, an average of 1 year
Secondary Outcome data - Death The rate of death during lenght of stay in hospital During hospital stay - hospital admission through study completion or until death if occured, up to 8 weeks
Secondary Outcome data Duration of the hospital length of stay Length of hospital stay measured in calendar days, hospital admission through study completion, up to 8 weeks
Secondary The oxygen consumption during the pre-hospital transport Mean O2 flow rate (total O2 consumption) during transportation Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance),
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