COPD Exacerbation, Trauma
Conditions
Keywords
prehospital, oxygen therapy, automation, trauma, COPD
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.
Interventions
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.
The flow of oxygen will be administered according to the usual protocol during the transport and until transfer to the emergency departement.
Sponsors
The Ottawa Hospital
Ottawa Hospital Research Institute
François Lellouche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This will be a single centered prehospital multi-period cluster crossover feasibility trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the study design - REB approval | 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 | 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 | through study completion, an average of 1 year | target: 100% of data captured in \>90% cases |
| Feasibility of the study design - study protocol compliance | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of patients without oxygen at the end of the transportation | Day 1 - At the end of the transportation (at the exit from the ambulance) | Rate of patient weaned of oxygen at the end of the transportation |
| Outcome data - NIV | through study completion, an average of 1 year | The rate of NIV use during lenght of stay in hospital |
| Outcome data - ICU admission | through study completion, an average of 1 year | The rate of ICU admission during lenght of stay in hospital |
| Oxygenation - Total Time in the target zone SpO2 | Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance) | 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%) |
| Outcome data | Length of hospital stay measured in calendar days, hospital admission through study completion, up to 8 weeks | Duration of the hospital length of stay |
| The oxygen consumption during the pre-hospital transport | Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance), | Mean O2 flow rate (total O2 consumption) during transportation |
| Outcome data - Death | During hospital stay - hospital admission through study completion or until death if occured, up to 8 weeks | The rate of death during lenght of stay in hospital |
| Oxygenation - Total time with hyperoxia | Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance) | Percentage of time spent in hyperoxia (SpO2 \> 94% in COPD patients and SpO2 \>98% in trauma patients) |
| Oxygenation - Total time with hypoxemia | Day 1 - During prehospital transportation (from entry in the ambulance until exit of the ambulance) | Percentage of time spent in the target zone SpO2 \- % of time with hypoxemia (SpO2\<86% in COPD patients and SpO2 \<90% in trauma patients) |
| The oxygentherapy complication- PaCO2 | Day 1- On The first ABG or capillary blood gases after hospital admission | -Evaluation of level of PaCO2 on the first ABG at ED or ICU admission (when available) |
| The oxygentherapy complication - respiratory acidosis | Day 1- On The first ABG or capillary blood gases after hospital admission | -Evaluation of the rate of respiratory acidosis (pH\<7.35 and PaCO2\>45mmHg) after hospital admission |
Contacts
Primary ContactMichael Austin
Backup ContactFrançois Lellouche
Outcome results
None listed