80 Participants Needed

Carbon Dioxide Breathing for Orthostatic Hypotension

JB
TS
RH
Overseen ByRasha Hamzeh, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The Autonomic (or "automatic") Nervous System (ANS) regulates internal processes, including control of heart rate and blood pressure (BP). When someone stands, and gravity tries to pull blood away from the brain, the ANS works to maintain BP and brain blood flow. Neurogenic Orthostatic Hypotension (NOH) occurs when our "fight-or-flight" part ("sympathetic") of the ANS fails. BP can drop a lot when upright, reducing blood flow and oxygen delivery to the brain, and this can cause symptoms of light-headedness, nausea, and fainting.One solution to help counter the effects of NOH may be to increase sympathetic activity by breathing higher levels of carbon dioxide. In healthy volunteers, small increases in the amount of inhaled carbon dioxide has been shown to increase BP in the upright position, and this improves symptoms!The objectives of the current study are to apply carbon dioxide in patients with NOH and healthy controls to: (a) evaluate the effects of breathing carbon dioxide on BP and brain blood flow, and (b) determine if a device that increases carbon dioxide while standing will work as a new therapy

Will I have to stop taking my current medications?

The trial excludes participants taking medications that could interfere with autonomic function testing, so you may need to stop certain medications. It's best to discuss your specific medications with the trial team to see if they are allowed.

Is carbon dioxide therapy safe for humans?

The research does not provide specific safety data on carbon dioxide therapy, but it highlights that excessive oxygen therapy can be harmful, especially for patients with conditions like COPD, which may involve carbon dioxide retention.12345

How does the treatment Sequential Gas Delivery for orthostatic hypotension differ from other treatments?

Sequential Gas Delivery, also known as Carbon Dioxide Therapy, is unique because it involves controlled breathing of carbon dioxide to manage orthostatic hypotension, which is different from traditional treatments that may not focus on gas delivery. This approach is novel as it uses the therapeutic effects of carbon dioxide, which is not a standard treatment for this condition.36789

Who Is on the Research Team?

SR

Satish R Raj, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent, travel to the University of Calgary, and are non-smokers. It's not for those with dementia, substance abuse issues, severe organ diseases, pregnant or breastfeeding women, people on certain medications affecting autonomic function or unable to wear a mask.

Inclusion Criteria

Able and willing to provide informed consent
I am either male or female.
People who do not smoke.
See 1 more

Exclusion Criteria

You have severe anxiety or somatization symptoms.
Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies
I need portable oxygen for breathing, either at rest or during physical activity.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Active Stand Tests with varying levels of CO2 and O2 to evaluate the effects on blood pressure and orthostatic tolerance

5 sessions
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sequential Gas Delivery
Trial Overview The study tests if breathing in higher levels of carbon dioxide (Sequential Gas Delivery) can help manage low blood pressure when standing in patients with Neurogenic Orthostatic Hypotension by increasing blood pressure and brain blood flow.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Active Control
Group I: +5mmHg CO2Experimental Treatment1 Intervention
Group II: +10mmHg CO2 + 50mmHg O2Experimental Treatment1 Intervention
Group III: +10mmHgExperimental Treatment1 Intervention
Group IV: +0mmHg CO2 Clamped at baselineExperimental Treatment1 Intervention
Group V: Room AirActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Published Research Related to This Trial

Oxygen is a crucial life-saving treatment for patients with severe hypoxemia, but its use has often been based on tradition rather than scientific evidence, leading to potential risks.
Excessive oxygen therapy can increase mortality rates in critically ill patients, even in those without conditions like COPD that predispose them to carbon dioxide retention, highlighting the need for more careful management of oxygen administration.
Oxygen Use in Critical Illness.O'Driscoll, BR., Smith, R.[2020]
The article emphasizes the importance of nurses understanding the safe administration of oxygen therapy, particularly for patients with chronic obstructive pulmonary disease (COPD) and type II respiratory failure.
It highlights potential complications that can arise from oxygen delivery in these patients, underscoring the need for careful monitoring and management during acute care.
Administration of oxygen therapy.McGloin, S.[2008]
Intermittent negative pressure ventilation (INPV) combined with increasing oxygen concentrations was tested on 17 male patients with severe COPD, successfully raising arterial oxygen levels without worsening carbon dioxide retention.
This method not only improved oxygen levels significantly (from 47.2 mm Hg to 61.5 mm Hg) but also reduced carbon dioxide levels (from 74.4 mm Hg to 65.6 mm Hg), suggesting it could be a safer alternative to intubation and mechanical ventilation for patients with severe respiratory failure.
Intermittent short-term negative pressure ventilation and increased oxygenation in COPD patients with severe hypercapnic respiratory failure.Sauret, JM., Guitart, AC., Rodríguez-Froján, G., et al.[2019]

Citations

Oxygen Use in Critical Illness. [2020]
Administration of oxygen therapy. [2008]
Intermittent short-term negative pressure ventilation and increased oxygenation in COPD patients with severe hypercapnic respiratory failure. [2019]
Implementing target range oxygen in critical care: A quality improvement pilot study. [2022]
Oxygen therapy and oxygen toxicity. [2022]
[Ambulatory long-term oxygen therapy]. [2016]
Effect of oxygen administration during sleep on skin surface oxygen and carbon dioxide tensions in patients with chronic lung disease. [2013]
Altitude mountain sickness among tourist populations: a review and pathophysiology supporting management with hyperbaric oxygen. [2011]
Controlled oxygen therapy and carbon dioxide retention during exacerbations of chronic obstructive pulmonary disease. [2015]
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