COPD ExacerbationNCT03696563
FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS
A study testing Automated oxygen administration - FreeO2 and Standard administration of oxygen flow in people with COPD Exacerbation and Trauma, run by François Lellouche.
Trial summary
Evaluation of automated oxygen titration in comparison with manual adjustment oxygen in the out-of-hospital setting by paramedics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation, Trauma
- What is being tested?
- Automated oxygen administration - FreeO2 and Standard administration of oxygen flow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patient:
- 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
- Able to measure SpO2 via pulse oximetry
- Trauma patient:
- Trauma: patients who sustain any trauma (minor or major), II) Able to measure SpO2 via pulse oximetry
- Pregnancy
Show all 9Show fewer
- 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).
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Automated Administration of Oxygen Using the FreeO2 Device in Ambulances for COPD and Trauma Patients: A Feasibility Study
Evaluation of automated oxygen titration in comparison with manual adjustment oxygen in the out-of-hospital setting by paramedics.
Read the 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.
- Conditions
- COPD Exacerbation, Trauma
- Being tested
- Automated oxygen administration - FreeO2, Standard administration of oxygen flow
- Keywords
- prehospital, oxygen therapy, automation, trauma, COPD
- Medical subject headings
- Wounds and Injuries, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated oxygen administration - FreeO2Device
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.
Standard administration of oxygen flowOther
The flow of oxygen will be administered according to the usual protocol during the transport and until transfer to the emergency departement.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | In this group, the - usual care based upon BLS-PCS with manual titration of oxygen. In this group the SpO2 was recorded any time with FreeO2 device - recording mode. Receives: Other: Standard administration of oxygen flow |
| FreeO2 group | Experimental | The adjustment of the oxygen flow will be made by the FreeO2 system, an automated titration to reach the SpO2 target set by paramedic. Receives: Device: Automated oxygen administration - FreeO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Date of REB submission to date of REB approval, target: until 3 months (90 days) from REB submission
Feasibility of the study design - initiate the clinical trial
Time to readiness to initiate the clinical trial
Measured: Target until 3 months (90 days) from REB approval
Feasibility of the study design - Evaluation of data collection tool
target: 100% of data captured in >90% cases
Measured: through study completion, an average of 1 year
Feasibility of the study design - study protocol compliance
Target of 80% of compliance for protocol intervention/control group
Measured: through study completion,an average of 1 year
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (11)
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%)
Measured: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
Oxygenation - Total time with hyperoxia
Percentage of time spent in hyperoxia (SpO2 > 94% in COPD patients and SpO2 >98% in trauma patients)
Measured: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
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)
Measured: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
The oxygentherapy complication- PaCO2
-Evaluation of level of PaCO2 on the first ABG at ED or ICU admission (when available)
Measured: Day 1- On The first ABG or capillary blood gases after hospital admission
The oxygentherapy complication - respiratory acidosis
-Evaluation of the rate of respiratory acidosis (pH<7.35 and PaCO2>45mmHg) after hospital admission
Measured: Day 1- On The first ABG or capillary blood gases after hospital admission
The rate of patients without oxygen at the end of the transportation
Rate of patient weaned of oxygen at the end of the transportation
Measured: Day 1 - At the end of the transportation (at the exit from the ambulance)
Outcome data - NIV
The rate of NIV use during lenght of stay in hospital
Measured: through study completion, an average of 1 year
Outcome data - ICU admission
The rate of ICU admission during lenght of stay in hospital
Measured: through study completion, an average of 1 year
Outcome data - Death
The rate of death during lenght of stay in hospital
Measured: During hospital stay - hospital admission through study completion or until death if occured, up to 8 weeks
Outcome data
Duration of the hospital length of stay
Measured: Length of hospital stay measured in calendar days, hospital admission through study completion, up to 8 weeks
The oxygen consumption during the pre-hospital transport
Mean O2 flow rate (total O2 consumption) during transportation
Measured: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance),
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study startSep 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This will be a single centered prehospital multi-period cluster crossover feasibility trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- François Lellouche
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital, Ottawa Hospital Research Institute
- Responsible party
- Sponsor-investigator, François Lellouche, Laval University
- Investigators
- Michael Austin, Principal investigator, Regional Paramedic Program for Eastern Ontario, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696563
- Sponsor's protocol ID
- 20180570-01H
- Status last verified
- Nov 2020
- First submitted
- 18 Dec 2017
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not plan to share individual participant data. All data if shared with be de-identified. Data will be stored on a secure server with access only by study personal.
Publications
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.
PubMed 19204511Johannigman 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.
PubMed 18385582Higuchi 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.
PubMed 3956333O'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.
PubMed 18838559Branson RD, Johannigman JA. Pre-hospital oxygen therapy. Respir Care. 2013 Jan;58(1):86-97. doi: 10.4187/respcare.02251.
PubMed 23271821Hale 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.
PubMed 18955625Aubier 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.
PubMed 6774639Aubier 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.
PubMed 6778278Dunn 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.
PubMed 1909846Sassoon 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.
PubMed 3565937DAVIES 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.
PubMed 15393115Wiener 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.
PubMed 4629769Murphy 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.
PubMed 11696486Pauwels 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.
PubMed 11316667Kettel 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.
PubMed 5109747
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Administration of Oxygen Using the FreeO2 Device in Ambulances for COPD and Trauma Patients: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03696563
- Acronym / sponsor ID
- 20180570-01H
- Conditions
- COPD Exacerbation, Trauma
- Keywords
- prehospital, oxygen therapy, automation, trauma, COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- François LelloucheUniversity, hospital or other
- Collaborators
- The Ottawa Hospital, Ottawa Hospital Research Institute
- Study start
- Sep 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a single centered prehospital multi-period cluster crossover feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Standard administration of oxygen flowIn this group, the - usual care based upon BLS-PCS with manual titration of oxygen. In this group the SpO2 was recorded any time with FreeO2 device - recording mode. |
| FreeO2 group | Experimental | Device: Automated oxygen administration - FreeO2The adjustment of the oxygen flow will be made by the FreeO2 system, an automated titration to reach the SpO2 target set by paramedic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Able to measure SpO2 via pulse oximetry
- Trauma: patients who sustain any trauma (minor or major), II) Able to measure SpO2 via pulse oximetry
- Pregnancy
- Age <18 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated oxygen administration - FreeO2The 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. | Device | FreeO2 group |
| Standard administration of oxygen flowThe flow of oxygen will be administered according to the usual protocol during the transport and until transfer to the emergency departement. | Other | Control group |
Primary outcome
Feasibility of the study design - REB approval
Time frame: Date of REB submission to date of REB approval, target: until 3 months (90 days) from REB submission
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
Feasibility of the study design - initiate the clinical trial
Time frame: Target until 3 months (90 days) from REB approval
Time to readiness to initiate the clinical trial
Feasibility of the study design - Evaluation of data collection tool
Time frame: through study completion, an average of 1 year
target: 100% of data captured in >90% cases
Feasibility of the study design - study protocol compliance
Time frame: through study completion,an average of 1 year
Target of 80% of compliance for protocol intervention/control group
Feasibility of the study design - Paramedics survey
Time frame: through study completion, an average of 1 year
A survey will be complete by Paramedics at the end of day of transportation (day 1); the target response rate is 75% of case.
11 secondary outcomes
Oxygenation - Total Time in the target zone SpO2
Time frame: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
Oxygenation - Total time with hyperoxia
Time frame: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
Oxygenation - Total time with hypoxemia
Time frame: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance)
The oxygentherapy complication- PaCO2
Time frame: Day 1- On The first ABG or capillary blood gases after hospital admission
The oxygentherapy complication - respiratory acidosis
Time frame: Day 1- On The first ABG or capillary blood gases after hospital admission
The rate of patients without oxygen at the end of the transportation
Time frame: Day 1 - At the end of the transportation (at the exit from the ambulance)
Outcome data - NIV
Time frame: through study completion, an average of 1 year
Outcome data - ICU admission
Time frame: through study completion, an average of 1 year
Outcome data - Death
Time frame: During hospital stay - hospital admission through study completion or until death if occured, up to 8 weeks
Outcome data
Time frame: Length of hospital stay measured in calendar days, hospital admission through study completion, up to 8 weeks
The oxygen consumption during the pre-hospital transport
Time frame: Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance),
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Background: PubMed 19204511Johannigman 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.
- Background: PubMed 18385582Johannigman 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.
- Background: PubMed 3956333Higuchi 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.
- Background: PubMed 18838559O'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.
- Background: PubMed 23271821Branson RD, Johannigman JA. Pre-hospital oxygen therapy. Respir Care. 2013 Jan;58(1):86-97. doi: 10.4187/respcare.02251.
- Background: PubMed 18955625Hale 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.
- Background: PubMed 6774639Aubier 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.
- Background: PubMed 6778278Aubier 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.
- Background: PubMed 1909846Dunn 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.
- Background: PubMed 3565937Sassoon 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.
- Background: PubMed 15393115DAVIES 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.
- Background: PubMed 4629769Wiener 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.
- Individual participant dataSharing planned: No. There is not plan to share individual participant data. All data if shared with be de-identified. Data will be stored on a secure server with access only by study personal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Austin principal investigator
Regional Paramedic Program for Eastern Ontario, Ottawa Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Automated oxygen administration - FreeO2 and Standard administration of oxygen flow in people with COPD Exacerbation and Trauma, run by François Lellouche.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Austin (613-737-7228, maustin@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the study design - REB approval (time frame: Date of REB submission to date of REB approval, target: until 3 months (90 days) from REB submission). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03696563, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.