Controlled Breathing for POTS
Recruiting in Palo Alto (17 mi)
Overseen bySatish R Raj, MD, MSCI
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Calgary
Disqualifiers: Somatization, Severe anxiety, Pregnancy, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The mechanism behind postural orthostatic tachycardia syndrome (POTS) involves many causes including a sympathetic nervous system problem. Blood gases, like carbon dioxide (CO2), have an important effect on sympathetic activation.
The purpose of this research study is to determine if higher CO2 levels have any effect in lowering heart rate and reducing POTS symptoms when upright/standing. The investigators are also searching for the ideal CO2 concentration to achieve the most effective response
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 study team for clarification.
What data supports the effectiveness of the RespirAct™ system treatment for POTS?
The effectiveness of the RespirAct™ system may be indirectly supported by research on feedback control systems used in ventilatory therapy, which have shown the ability to maintain stable levels of carbon dioxide in the blood. This suggests that similar feedback mechanisms in the RespirAct™ system could help manage symptoms in POTS by stabilizing breathing patterns.
12345How is the RespirAct™ system treatment for POTS different from other treatments?
The RespirAct™ system is unique because it uses controlled breathing to manage POTS, which is different from typical drug-based treatments. This system allows precise control of breathing parameters, potentially improving blood flow and oxygen levels without medication.
678910Eligibility Criteria
This trial is for adults aged 18-60 with a physician's diagnosis of Postural Tachycardia Syndrome (POTS) who can visit the University of Calgary and are non-smokers. Pregnant individuals, those needing portable oxygen, or with severe heart/lung disease, anxiety disorders, or poor past study compliance cannot participate.Inclusion Criteria
Able and willing to provide informed consent
I am between 18 and 60 years old.
I have been diagnosed with POTS by a doctor.
+3 more
Exclusion Criteria
I need portable oxygen for breathing, either at rest or during physical activity.
I cannot climb stairs without feeling short of breath due to heart or lung problems.
I have a rapid heartbeat when standing up due to severe dehydration.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants undergo hypercapnia intervention using the RespirAct™ system to assess effects on heart rate and orthostatic tolerance
8 weeks
Weekly visits for intervention and monitoring
Follow-up
Participants are monitored for safety and effectiveness after intervention
4 weeks
Participant Groups
The study tests if controlled breathing using the RespirAct™ system to increase CO2 levels can reduce rapid heartbeat and improve symptoms in POTS patients when standing. The goal is to find the best CO2 level for symptom relief.
1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment1 Intervention
All participants will receive the same interventions
RespirAct™ system is already approved in Canada for the following indications:
🇨🇦 Approved in Canada as RespirAct system for:
- Research use in controlling blood gas concentrations for conditions like Postural Orthostatic Tachycardia Syndrome (POTS)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of CalgaryCalgary, Canada
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Who Is Running the Clinical Trial?
University of CalgaryLead Sponsor
References
A demand diaphragm pacemaker. [2019]A PACO2 feedback control system (demand diaphragm pacemaker) was developed in this laboratory to maintain homeostasis during diaphragm pacing, thus avoiding hypo- or hyperventilation. Application of this system to the research animal made it possible to maintain blood gases and pH within normal limits for up to 15 hrs. Oscillation between maximal tidal volume and apnea that occurred with the amplitude feedback control was eliminated by using a rate feedback control. A possible additional benefit of a feedback control system is the reduction of current applied to the nerve as compared to that in asynchronous pacing, thereby minimizing the fatigue phenomenon.
A feedback controller for ventilatory therapy. [2019]A computerized system that uses feedback of end-tidal CO2 fraction (FETCO2) to adjust minute volume of a ventilator has been developed and tested. The effectiveness and robustness of the controller were evaluated in five anesthetized dogs. The controller responded to step-changes in the set-point for FETCO2 by adjusting minute volume so that the FETCO2 settled to the new set-point in less than 60 sec with less than 20% overshoot. The system exhibited suitable dynamic response to step-changes in set-point with loop gains as large as two times and as small as one-half the optimal value. The breath-to-breath variation in FETCO2 values during prolonged periods of closed-loop controlled ventilation was smaller than the variation during periods of constant minute volume ventilation in three of five experiments. The controller generally maintained FETCO2 within +/- 0.1 vol% of the set-point. A disturbance to the controlled system was produced by releasing an occlusion of a branch of the pulmonary artery. The controller always responded to this disturbance in a stable manner, returning the FETCO2 to its desired value within 30 sec. Accurate control of arterial partial pressure of CO2(PaCO2) will require modifications enabling the system to determine the relationship between FETCO2 and PaCO2.
[Measuring intracardiac impedance for the determination of sympathetic nerve activity in frequency-adapted electrostimulation--Part 2: Clinical results]. [2019]The results of a multicenter clinical study involving patients receiving the first ANS controlled rate adaptive pacemaker are presented. In the patients with primary or secondary chronotropic insufficiency, it is possible to reestablish the closed loop control system that includes the baroreceptors, the medulla oblongata, the cardiac output and the mean arterial blood pressure. This system serves to keep the blood pressure constant in the face of changing demands on the circulation. Utilizing intracardiac impedance measurements, the myocardial contractility can be determined, which contains information about the current sympathetic tone, and thus represents an excellent physiological input for a rate adaptive mechanism. The results presented are taken from a study population of over 200 patients. The objective evaluation of this new approach was performed echocardiographically, by ergometry and 24-hour Holter monitoring.
Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial. [2022]To compare the effect of two different automated oxygen control devices on target range (TR) time and occurrence of hypoxaemic and hyperoxaemic episodes.
Factors Affecting Optimal Titration Pressure of Continuous Positive Airway Pressure Device in Patients with Obstructive Sleep Apnea Syndrome. [2022]To assess the effects of anatomical, clinical parameters, and pulmonary respiratory function on the therapeutic titration pressure of continuous positive airway pressure (CPAP) device in obstructive sleep apnea syndrome (OSAS).
[The Bain circuit. Theoretical aspects and clinical use]. [2006]After a concise theoretical presentation of the present stage of semiclosed circuits, the authors assess their personal experience in the use of the Bain system. Under controlled respiration, adminstration of a fresh flow of gases of 70 ml per Kg of body weight-1 per minute-1 (between 4,5 and 6 1 per minute-1) prevents reinchalation. By its characteristics, which include: on optimal control of PaCO2 by a simple variation of the flow of fresh gases, universality, economy, the Bain system has demonstrated its utility in the anesthetics practice.
Servo respirator constructed from a positive-pressure ventilator. [2017]We have constructed an electronically controlled respirator from three commercially available components: a positive-pressure ventilator, a recorder pen motor, and a differential amplifier. Using negative feedback derived from a tracheal pressure signal, the instrument functions as a servo respirator which provides precise control of tracheal pressure. The system's power and response characteristics are well suited for ventilation of anesthetized cats and dogs. The servo respirator can be used as an externally controlled respiratory pump which provides flexibility in selection of the parameters of the ventilatory cycle. Alternatively, it can function as a "demand" respirator which generates transthoracic pressure proportional to efferent respiratory discharge.
The use of respirators in patients with complicated myocardial infarction. [2016]The results of controlled respiration as treatment in 20 patients with complicated myocardial infarction are presented. The clinical indications to this method of treatment included: shock, pulmonary oedema refractory to treatment, recurrent ventricular fibrillation and respirator failure following cardiac arrest. An indication for the use of this method is a drop in PaO2 below 70 mm Hg despite breathing 30% oxygen. Neuroleptanalgesic drugs were administered routinely while the patient was on the respirator. In all cases at least two prognostically unfavourable clinical signs were found. A correlation was observed between the clinical result and hypoxaemia after breathing 100% oxygen.
A closed-loop controller for mechanical ventilation of patients with ARDS. [2020]Mechanical ventilators are routinely used to care for patients who cannot adequately breath on their own. Management of mechanical ventilation often involves a careful watch of the patient's arterial blood-oxygen tension and requires frequent adjustment of ventilation parameters to optimize the therapy. This situation lends itself as a candidate for closed-loop control. This report describes a closed-loop control system based on well-established protocols to systematically maintain appropriate levels of positive end-expiratory pressure (PEEP) and inspired oxygen (FiO2) in patients with Adult Respiratory Distress Syndrome (ARDS). The closed-loop control system consists of an in-dwelling arterial oxygenation (PaO2) sensor (Pfizer Continucath), coupled to a Macintosh computer that continuously controls FiO2 and PEEP settings on a Hamilton Amadeus ventilator. The implemented protocols provide continuous closed-loop control of oxygenation and a balance between patient need and minimal therapy. The controller is based on a traditional proportional-integral-derivative (PID) approach. The idea is to control, or maintain, the patient's PaO2 level at a target value determined, or set, by the patient's physician. The controller also features non-linear and adaptive characteristics that allow the system to respond more aggressively to "threatening" levels of PaO2. Another benefit of the control system is the ability to display, monitor, record and store all system parameters, settings, and control variables for future analysis and study. The system was extensively tested in the laboratory and in animal trials prior to use on human subjects. The results of a small clinical trial indicated that the system maintained control of the patient's therapy nearly 84% of the time. During the remainder of this time, the controller was interrupted primarily for suctioning, PaO2 sensor calibration or replacement. The response of the closed-loop controller was found to be appropriate, reliable and safe in patients with ARDS.
[CFR - Continuous Flow Reviver - a new device for respiratory resuscitation]. [2020]We developed a new device for respiratory revival in order to do it better than by using the auto inflating reanimation purse, which is common in this emergency situation. This is a portable equipment, handly operated, that controls a continuous flow of gas with until 100% of oxygen, that permits to define both peak inspiratory pressure and positive end expiratory pressure. Both inspiratory and expiratory time can be controlled by the operator during the revive process. All process can be effected using endotracheal tube or mask.