Automated Oxygen Adjustment for COPD Exacerbations
(FreeO2 HypHop Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Laval University
Disqualifiers: Pulmonary embolism, Cardiac edema, Pneumothorax, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment FreeO2 for COPD exacerbations?
Research shows that the FreeO2 system, which automatically adjusts oxygen flow based on patient needs, helps maintain stable oxygen levels in COPD patients during activities like walking. This system can prevent both too much oxygen (hyperoxia) and too little oxygen (hypoxemia), which are important for patient safety and health.12345
Is automated oxygen adjustment safe for humans?
How is the treatment FreeO2 different from other treatments for COPD exacerbations?
Eligibility Criteria
This trial is for adults over 40 with COPD or suspected COPD, who have a history of smoking and are experiencing an acute exacerbation. They should need moderate oxygen therapy to maintain certain blood oxygen levels but not require advanced respiratory support like intubation. Patients with conditions such as pulmonary embolism, cardiac issues, pneumothorax, or severe encephalopathy cannot participate.Inclusion Criteria
I have recently been experiencing worsening shortness of breath.
I am over 40 and have a history of heavy smoking.
I have more mucus, changes in mucus color, or increased difficulty breathing.
See 1 more
Exclusion Criteria
I have chosen not to participate in this trial.
The patient is not able or willing to cooperate with the study requirements.
You have a brain condition with a score higher than 2.
See 7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive either manual or automated oxygen titration during hospitalization
1 week
Inpatient stay
Follow-up
Participants are monitored for hospital readmission and other outcomes after discharge
12 weeks
Treatment Details
Interventions
- FreeO2 (Device)
Trial OverviewThe study compares two ways of giving oxygen to patients: one uses the FreeO2 device that automatically adjusts oxygen levels, while the other method involves manual adjustment by healthcare staff. The goal is to see if the FreeO2 can shorten hospital stays for those having a severe flare-up of their COPD.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Manual Oxygen titrationExperimental Treatment1 Intervention
In this arm, a manual adjustment of oxygen during patient hospitalisation by hospital staff
Group II: Automated Oxygen titrationExperimental Treatment1 Intervention
In this arm, an automated adjustment of oxygen during patient hospitalisation by FreeO2 device
FreeO2 is already approved in European Union, Canada, United Kingdom for the following indications:
🇪🇺 Approved in European Union as FreeO2 for:
- Chronic Obstructive Pulmonary Disease (COPD)
- Acute Respiratory Distress Syndrome (ARDS)
🇨🇦 Approved in Canada as FreeO2 for:
- Chronic Obstructive Pulmonary Disease (COPD)
- Acute Respiratory Distress Syndrome (ARDS)
🇬🇧 Approved in United Kingdom as FreeO2 for:
- Chronic Obstructive Pulmonary Disease (COPD)
- Acute Respiratory Distress Syndrome (ARDS)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Institut Universitaire de Cardiologie et de Pneumologie de QuébecQuebec, Canada
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Who Is Running the Clinical Trial?
Laval UniversityLead Sponsor
References
Automated oxygen titration and weaning with FreeO2 in patients with acute exacerbation of COPD: a pilot randomized trial. [2022]We developed a device (FreeO2) that automatically adjusts the oxygen flow rates based on patients' needs, in order to limit hyperoxia and hypoxemia and to automatically wean them from oxygen.
Computer-assisted adjustment of inspired oxygen concentration improves control of oxygen saturation in newborn infants requiring mechanical ventilation. [2019]Open-loop computer control of inspired oxygen concentration was evaluated in 16 newborn infants requiring mechanical ventilation. FIO2 and oxygen saturation were compared for 2-hour periods of computer versus routine manual FIO2 adjustment. During computer-assisted FIO2 adjustment, patients spent more time at the target SaO2 and less time with SaO2
Optimal oxygen titration in patients with chronic obstructive pulmonary disease: a role for automated oxygen delivery? [2021]Oxygen therapy can be life-saving for patients with chronic obstructive pulmonary disease (COPD) and is the backbone of any acute COPD treatment strategy. Although largely considered to be a benign drug, many publications have highlighted the need to accurately adjust oxygen delivery to avoid both hypoxemia and the problem of hyperoxia-induced hypercapnia. Recent clinical data have shown that the deleterious effects of excess oxygen treatment can not only alter carbon dioxide levels (which has been known for more than 60 years) but can also lead to an increase in mortality. Nevertheless, despite the extensive literature, the risks associated with hyperoxia are often overlooked and published clinical recommendations are largely ignored. This failure in knowledge translation has become increasingly important not only because of the desire to reduce medical error, but in a society with limited health care resources, the economic burden of COPD is such that it cannot afford to make preventable medical mistakes. Recently, novel devices have been developed to automatically adjust oxygen flow rates to maintain stable oxygen saturations. These closed-loop oxygen delivery systems have the potential to reduce medical error, improve morbidity and mortality, and reduce health care costs. Preliminary data in this field are promising and will require a significant amount of research in the coming years to determine the precise indications for these systems. The importance of appropriate oxygen dosing and the current literature regarding novel oxygen delivery systems are reviewed.
Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Arterial oxygen desaturation frequently occurs in patients with COPD during daily activities at home. Oxygen flow is usually set at fixed and low rates for ambulatory patients. We evaluated an innovative closed-loop system (FreeO2) that automatically adjusts the oxygen flow to the patient's needs in subjects with COPD during walking followed by recovery time, such as during ambulatory conditions.
Automated Home Oxygen Delivery for Patients with COPD and Respiratory Failure: A New Approach. [2020]Long-term oxygen therapy (LTOT) has become standard care for the treatment of patients with chronic obstructive pulmonary disease (COPD) and other severe hypoxemic lung diseases. The use of new portable O2 concentrators (POC) in LTOT is being expanded. However, the issue of oxygen titration is not always properly addressed, since POCs rely on proper use by patients. The robustness of algorithms and the limited reliability of current oximetry sensors are hindering the effectiveness of new approaches to closed-loop POCs based on the feedback of blood oxygen saturation. In this study, a novel intelligent portable oxygen concentrator (iPOC) is described. The presented iPOC is capable of adjusting the O2 flow automatically by real-time classifying the intensity of a patient's physical activity (PA). It was designed with a group of patients with COPD and stable chronic respiratory failure. The technical pilot test showed a weighted accuracy of 91.1% in updating the O2 flow automatically according to medical prescriptions, and a general improvement in oxygenation compared to conventional POCs. In addition, the usability achieved was high, which indicated a significant degree of user satisfaction. This iPOC may have important benefits, including improved oxygenation, increased compliance with therapy recommendations, and the promotion of PA.
Automated O2 titration improves exercise capacity in patients with hypercapnic chronic obstructive pulmonary disease: a randomised controlled cross-over trial. [2019]Automatically titrated O2 flows (FreeO2) was compared with constant O2 flow on exercise capacity, O2 saturation and risk of hyperoxia-related hypercapnia in patients with severe COPD with baseline hypercapnia and long-term oxygen therapy (LTOT). Twelve patients were enrolled in a randomised double-blind cross-over study to perform exercise with either FreeO2 or constant flow. Endurance time (primary outcome) and SpO2 were both significantly improved with FreeO2compared with constant flow (p<0.04), although pCO2 was similar in both conditions. Automated titration of O2 significantly and clinically improved endurance walking time in patients with severe COPD receiving LTOT, without worsening of pCO2 TRIAL REGISTRATION NUMBER: Results , NCT01575327.
Performance of a reservoir nasal cannula (Oxymizer) during sleep in hypoxemic patients with COPD. [2019]To determine whether a reservoir nasal cannula (RNC) (Oxymizer) provides an arterial hemoglobin oxygen saturation as measured by pulse oximetry (SpO2) equivalent to that provided by the standard nasal cannula (SNC) during sleep in hypoxemic patients with COPD while reducing oxygen flow requirement and cost.
Automated Oxygen Administration Alleviates Dyspnea in Patients Admitted with Acute Exacerbation of COPD: A Randomized Controlled Trial. [2023]Devices for Automated Oxygen Administration (AOA) have been developed to optimize the therapeutic benefit of oxygen supplementation. We aimed to investigate the effect of AOA on multidimensional aspects of dyspnea and as-needed consumption of opioids and benzodiazepines, as opposed to conventional oxygen therapy, in hospitalized patients with Acute Exacerbation of COPD (AECOPD).