Comparing Washout period with CPAP - Oxygen constant flow for COPD exacerbation
Official title: Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
Influence of Automatic Oxygen Titration Device (FreeO2) on Percentage of Time Within Oxygen Saturation Target and Induced Hypercapnia During Noninvasive Ventilation for Patients Hospitalized for an Acute Exacerbation of COPD or a Bariatric Surgery
- 2 groups
- One site, in Québec
- Recruiting
Interventions (5)
- Other intervention
Washout period
During this period the patients will breath spontaneously oxygen titrated using the FreeO2 device with a SpO2 target set at 90%. The period duration is 30 minutes.
- Medical device
NIV - FreeO2
During this period the patients will receive NIV using FreeO2 device for oxygen titration with a SpO2 target set at 90%. Initially, the inspiratory pressure will be set to obtain a tidal volume between 6 to 8 mL/Kg of predictive body weight and positive end-expiratory end pressure (PEEP) at 5 centimeters of water (cmH2O). After NIV initiation, the parameters can be adjusted to improve patient comfort. The period duration is 30 minutes.
- Medical device
Nasal High flow Oxygen therapy - FreeO2
During this period the patients will receive NHFOT using the FreeO2 device for oxygen titration with a SpO2 target set at 90%. The high flow device will be set at 30 lpm.The period duration is 30 minutes.
- Other intervention
CPAP - Oxygen constant flow
During this period, the patients will have their own CPAP with oxygen adjusted by hospital staff according to hospital protocol. The period duration is 15 minutes.
- Other intervention
CPAP - FreeO2
During this period, the patients will have their own CPAP with oxygen adjusted using the FreeO2 device. SpO2 target will be set at 90% The period duration is 60 minutes.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Institut universitaire de Cardiologie et de Pneumologie - Université Laval
Québec, Quebec
Eligibility Criteria
See who this study is looking for12 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Respiratory acidosis (pH \<= 7.35 and PaCO2 \> 45 mmHg), with or without NIV (last blood gas available during hospitalization)
- +Oxygen therapy and/or SpO2 \<90% room air (FiO2 \<= 50% or nasal cannula \<= 7 L/min to maintain SpO2 90%)
- +High flow nasal cannula with flow \<= 30 L/min
- +Patients with obesity hypoventilation syndrome in addition to obstructive sleep apnea can be included.
- +Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → (Bariatric surgery post-op):
- +Patients using CPAP before the surgery (obstructive sleep apnea documented).
Exclusion
- −Respiratory distress or other clinical situation requiring continuous NIV or CPAP
- −Glasgow \< 12 or agitation/delirium/dementia (limiting NIV)
- −Hemodynamic instability (at the beginning of the study) (increasing doses of vasopressors or inotropes)
- −Refusal to consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to the study
- −Any contraindication to NIV (state requiring immediate endotracheal intubation, pneumothorax, recent esophagus surgery)
- −patient with AECOPD and 5 patient with bariatric surgery will be included.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives one or more of: Washout periodWashout periodA gap with no treatment, so the previous one clears your system.Read more →, NIV - FreeO2 and Nasal High flow Oxygen therapy - FreeO2.
Registry label: A: COPD patients
Group B receives one or more of: CPAP - Oxygen constant flow and CPAP - FreeO2.
Registry label: B: Bariatric surgery patients
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 10 people.
The study is currently expected to finish around June 2028.
The main measurement is taken over: AECOPD Patients: Day 1; Up to 120 minutes after start study procedures. Bariatric surgery patients: Day 1; up to 75 minutes after start study procedures(post-op).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percentage of time within SpO2 target — measured over AECOPD Patients: Day 1; Up to 120 minutes after start study procedures. Bariatric surgery patients: Day 1; up to 75 minutes after start study procedures(post-op).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04136717 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Washout periodOther
During this period the patients will breath spontaneously oxygen titrated using the FreeO2 device with a SpO2 target set at 90%. The period duration is 30 minutes.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About NIV - FreeO2Device
During this period the patients will receive NIV using FreeO2 device for oxygen titration with a SpO2 target set at 90%. Initially, the inspiratory pressure will be set to obtain a tidal volume between 6 to 8 mL/Kg of predictive body weight and positive end-expiratory end pressure (PEEP) at 5 centimeters of water (cmH2O). After NIV initiation, the parameters can be adjusted to improve patient comfort. The period duration is 30 minutes.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Nasal High flow Oxygen therapy - FreeO2Device
During this period the patients will receive NHFOT using the FreeO2 device for oxygen titration with a SpO2 target set at 90%. The high flow device will be set at 30 lpm.The period duration is 30 minutes.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About CPAP - Oxygen constant flowOther
During this period, the patients will have their own CPAP with oxygen adjusted by hospital staff according to hospital protocol. The period duration is 15 minutes.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About CPAP - FreeO2Other
During this period, the patients will have their own CPAP with oxygen adjusted using the FreeO2 device. SpO2 target will be set at 90% The period duration is 60 minutes.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: AECOPD Patients: Day 1; Up to 120 minutes after start study procedures. Bariatric surgery patients: Day 1; up to 75 minutes after start study procedures(post-op)..
The study as a whole is currently expected to finish around 2028-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 10 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Québec, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The main objective is to evaluate the FreeO2 device combined with noninvasive respiratory support technique for COPD patients and postoperative bariatric surgery patients. The main hypothesis is that FreeO2 device for oxygen therapy associated with NIV or nasal high flow oxygen therapy (NHFOT) allows to reach better oxygenation and avoid hypoxemia and hyperoxia.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.