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New treatment option 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
ClinicalTrials.gov ID: NCT04136717
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (AECOPD):
- Respiratory acidosis (pH \ 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 (Bariatric surgery post-op):
- Patients using CPAP before the surgery (obstructive sleep apnea documented).
You likely can't join if
- Age \< 18
- Pregnancy
- Respiratory distress or other clinical situation requiring continuous NIV or CPAP
- Glasgow \< 12 or agitation/delirium/dementia (limiting NIV)
- Any contraindication to NIV (state requiring immediate endotracheal intubation, pneumothorax, recent esophagus surgery)
- Hemodynamic instability (at the beginning of the study) (increasing doses of vasopressors or inotropes)
See the full eligibility criteria
- (AECOPD):
- Respiratory acidosis (pH \ 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 (Bariatric surgery post-op):
- Patients using CPAP before the surgery (obstructive sleep apnea documented).
- Patients with obesity hypoventilation syndrome in addition to obstructive sleep apnea can be included.
- Age \< 18
- Pregnancy
- Respiratory distress or other clinical situation requiring continuous NIV or CPAP
- Glasgow \< 12 or agitation/delirium/dementia (limiting NIV)
- Any contraindication to NIV (state requiring immediate endotracheal intubation, pneumothorax, recent esophagus surgery)
- Hemodynamic instability (at the beginning of the study) (increasing doses of vasopressors or inotropes)
- Refusal to consent to the study 5 patient with AECOPD and 5 patient with bariatric surgery will be included.
The study team makes the final eligibility decision.
Where it's taking place
- Québec, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Québec, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.