Oxygenation for Vascular Lesions

Overseen By Kristi Kearney, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Age < 18, Age > 90, Colon ulcerations, Previous colon surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of oxygenation (the process of adding oxygen) in the colon for individuals with specific vascular issues, particularly in the upper colon. The trial compares two groups: one with vascular abnormalities and one with healthy colons. It suits individuals who have undergone a colonoscopy and have a history of vascular lesions in their colon. Participants must not have any colon ulcers or a history of colon surgeries. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance understanding and treatment of vascular issues in the colon.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that oxygen saturation is safe for evaluating vascular lesions?

Research has shown that maintaining blood oxygen levels between 88% and 93% can be beneficial, such as reducing eye problems in newborns. This highlights the importance of managing oxygen levels effectively.

Hyperbaric oxygen therapy involves breathing pure oxygen in a special chamber to boost oxygen levels. While excessive pressure can cause side effects, the therapy is generally safe when administered correctly. It can enhance blood flow and aid tissue healing.

Overall, careful control of oxygen levels in the body is usually well-tolerated and typically does not cause major issues when performed properly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about oxygen saturation as a treatment for vascular lesions because it offers a novel approach by focusing on enhancing oxygen delivery to affected areas. Unlike traditional treatments that often rely on surgical interventions or medications to manage symptoms, this method aims to improve the body's natural healing process by optimizing oxygen levels. This technique could potentially lead to quicker recovery times and fewer side effects, making it a promising alternative to existing options.

What evidence suggests that oxygen saturation might be an effective treatment for vascular lesions?

Research has shown that oxygen levels play a crucial role in managing blood vessel problems. This trial will compare the effects of oxygen therapy on individuals with acquired vascular abnormalities in the proximal colon to a control group with a healthy colon. Studies have found that increasing oxygen, particularly through treatments like hyperbaric oxygen therapy (HBOT), might enhance blood flow and alleviate issues in these conditions. More oxygen can aid the body in repairing and maintaining blood vessels. Although few studies focus specifically on colon-related blood vessel problems, the success of oxygen treatments in other areas suggests potential benefits. Early findings support the idea that improved oxygen levels could help manage symptoms of blood vessel issues in the colon. ^{3 4 6 7 8}

Who Is on the Research Team?

Joel Pekow, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults aged 18-89 who are undergoing a routine colonoscopy and either have a history of vascular lesions in the colon or have a healthy colon. It's not open to those under 18, over 90, with ulcerations at the ascending colon opposite the ileocecal valve, or who've had previous colon surgery.

Inclusion Criteria

My colon is healthy.

I will have a routine colonoscopy as part of my care.

I have had blood vessel issues in my colon.

Exclusion Criteria

I am under 18 years old.

I am over 90 years old.

I have ulcers in the upper part of my large intestine near the small intestine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Evaluation

Participants undergo evaluation of colonic oxygen saturation levels

12 months

Regular visits for oxygen saturation measurement

Follow-up

Participants are monitored for safety and effectiveness after evaluation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oxygen saturation

Trial Overview The study aims to measure how well oxygen gets to parts of the large intestine (colon) in people with abnormal blood vessels there. This will be done during their standard care procedure for examining the inside of their large intestine.

How Is the Trial Designed?

Group I: Vascular abnormality group Experimental Treatment 1 Intervention

People with acquired vascular abnormalities in the proximal colon

Group II: Control group Active Control 1 Intervention

People with healthy colon

Oxygen saturation is already approved in United States, European Union for the following indications:

Approved in United States as Oxygen therapy for:

• Respiratory distress
• Cardiovascular emergencies
• Carbon monoxide poisoning
• Decompression sickness

Approved in European Union as Oxygen therapy for:

• Respiratory failure
• Cardiac arrest
• Carbon monoxide poisoning
• Gas gangrene

Approved in United States as Hyperbaric oxygen therapy for:

• Carbon monoxide poisoning
• Decompression sickness
• Gas gangrene
• Crush injuries

Approved in European Union as Hyperbaric oxygen therapy for:

• Carbon monoxide poisoning
• Decompression sickness
• Gas gangrene
• Diabetic foot ulcers

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

Adjunctive hyperbaric oxygen therapy is a safe and effective treatment that can enhance healing in complicated acute wounds, flaps, and grafts when used alongside standard wound management practices, based on a review of eight relevant studies.

While hyperbaric oxygen therapy shows promise for improving healing in difficult cases, it is not recommended for normal wound management, indicating that more research is needed to establish its role as a standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does hyperbaric oxygen therapy work in facilitating acute wound healing: a systematic review. Dauwe, PB., Pulikkottil, BJ., Lavery, L., et al.[2022]

Hyperbaric oxygen therapy has been shown to effectively treat trauma-induced compartment syndrome, as demonstrated in a case where it reduced edema and improved tissue viability after surgical decompression.

The therapy works by enhancing oxygen delivery to tissues, which is crucial for recovery in conditions like compartment syndrome, suggesting it could be a valuable treatment option in similar acute traumatic injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive treatment of compartment syndrome with hyperbaric oxygen. Fitzpatrick, DT., Murphy, PT., Bryce, M.[2017]

Hyperbaric oxygen therapy (HBO) is effective in improving tissue oxygenation and promoting wound healing, making it a key treatment for conditions like severe carbon monoxide poisoning and diabetic foot wounds.

HBO is considered safe with minimal adverse effects when administered according to standard protocols, although further research is needed to explore its efficacy for other potential uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen therapy (HBO): current standing]. Haltern, C., Siekmann, UP., Rump, AF., et al.[2006]

Hyperbaric oxygen therapy (O.H.B.) was tested on 2,021 patients with limb arteriopathies from 1966 to 1983, showing no complications and a significant increase in oxygen levels in the blood, which may help treat these conditions.

In 40% of cases, O.H.B. facilitated the movement of blood from healthy areas to hypoxic (low oxygen) regions, suggesting it could be an effective treatment for asymptomatic arteriopathy by improving blood flow to affected areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygenation and arteriopathies]. Fredenucci, P.[2013]

Hyperbaric oxygen therapy can improve oxygen delivery to tissues affected by trauma, potentially reducing cell death and secondary ischemia in patients with crush injuries or compartment syndrome.

Recent studies have confirmed the efficacy of hyperbaric oxygen therapy in trauma patients, but further research is needed to establish optimal treatment protocols and additional uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy in extremity trauma. Greensmith, JE.[2019]

Inhalation of 100% oxygen under pressure, known as hyperbaric oxygen therapy, can significantly enhance healing by improving oxygen delivery to tissues, which promotes the growth of new blood vessels.

This therapy is particularly beneficial for patients suffering from conditions like tissue damage after radiation, refractory osteomyelitis, gas gangrene, and non-healing wounds, making it a valuable adjunctive treatment in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy. Promoting healing in difficult cases. Cohn, GH.[2019]

In a study of 2,334 patients undergoing hyperbaric oxygen (HBO2) therapy, 17.4% experienced adverse events, with the most common being middle ear barotrauma affecting 9.2% of patients.

Despite some side effects, the overall incidence of complications was low at 0.72% per session, indicating that with proper protocols and monitoring, HBO2 therapy is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients. hadanny, A., Meir, O., Bechor, Y., et al.[2016]

In a study of 80 patients with arterial occlusive disease (AOD) and diabetic angiopathy (DA), those receiving hyperbaric oxygen (HBO) therapy in addition to standard treatment showed significantly better healing outcomes, with 9 patients improving compared to only 1 in the non-HBO group.

HBO therapy not only enhanced wound healing but also reduced the number of lower-limb amputations in patients with AOD and DA, supporting its clinical use for treating diabetic lower-extremity wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Occlusive Arterial Disease and Diabetic Angiopathy Treatment Effects by Hyperbaric Oxygenation. Begić, A., Dilić, M.[2022]

A study of 155 patients undergoing hyperbaric oxygen (HBO₂) therapy revealed that there is a measurable increase in blood pressure (systolic, diastolic, and mean arterial pressure) following treatment, although the increase is not large.

Patients taking calcium channel blockers and beta-blockers experienced greater increases in blood pressure, while those on ACE inhibitors had a protective effect, suggesting that medication type can influence blood pressure responses during HBO₂ therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of hyperbaric oxygen therapy on blood pressure in patients undergoing treatment. Heyboer Rd, M., Wojcik, SM., Smith, G., et al.[2019]

In a study involving 7 young, healthy individuals with severe vascular trauma, standard vascular repair alone did not restore adequate blood circulation, leaving the limbs ischaemic.

Hyperbaric oxygen treatment at pressures of 2-8 atm successfully prevented gangrene in all cases, suggesting it is a valuable addition to reconstructive vascular surgery, especially when performed later after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen treatment as an adjuvant to reconstructive vascular surgery in trauma. Monies-Chass, I., Hashmonai, M., Hoere, D., et al.[2019]

In a study of 115 patients undergoing coronary stent implantation, those who received hyperbaric oxygen (HBO2) therapy showed significant improvements in vascular endothelial function, indicated by higher levels of flow-mediated dilation (FMD), nitric oxide (NO), and calcitonin gene-related peptide (CGRP) compared to the control group.

HBO2 therapy also resulted in lower levels of high-sensitivity C-reactive protein (hs-CRP) and endothelin-1 (ET-1), suggesting it may help reduce inflammation and improve vascular health in patients with coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen may improve vascular endothelial function in patients undergoing coronary stent implantation. Li, Y., Hao, YF., Wang, T., et al.[2019]

Hyperbaric oxygen therapy, which involves breathing 100% oxygen under high pressure, significantly increases the amount of oxygen available for cellular metabolism, leading to various beneficial effects that support healing in conditions like clostridial myonecrosis and chronic wounds.

While hyperbaric oxygen is now recognized as an effective adjunctive treatment for several medical conditions, further randomized controlled trials are needed to fully establish its efficacy and optimize its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hyperbaric oxygen therapy in trauma surgery]. Mutschler, W., Muth, CM.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11047301/

Assessing the Effectiveness of Different Hyperbaric Oxygen ... The presumptive underlying causes of SSNHL are autoimmune reactions, traumatic events, metabolic disorders, and vascular abnormalities [5,6,7,8] ...

2. jvascsurg.org jvascsurg.org/article/S0741-5214(19)32157-3/fulltext

A systematic review and meta-analysis of hyperbaric ... Inclusion and exclusion criteria, data extraction, and outcomes of interest ... Journal of Vascular Surgery: Venous and Lymphatic Disorders · Journal of ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213510315000159

Clinical Effectiveness of Hyperbaric Oxygen Therapy in ... Hyperbaric oxygen therapy (HBOT) has been utilized and has recently shown promising effects in the management of FM and other chronic pain disorders. In ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1160774/full

Adverse effects of hyperbaric oxygen therapy: a systematic ... Within children with neurological disorders, adverse effects regarding hyperbaric oxygen therapy did not differ significantly from controls, probably due to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6306846/

Hyperbaric Oxygen Therapy Enhanced Circulating Levels ... ... disorders, malignancy, febrile disorders, acute or chronic inflammatory disease at study enrollment, congestive heart failure (New York Heart Association ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5467109/

Hyperbaric Oxygen Therapy: Side Effects Defined and ... Targeting oxygen saturation between 88% and 93% has been shown to result in a significant reduction in retinopathy of prematurity. Arterial pO2 is 90 to 110 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8465921/

A General Overview on the Hyperbaric Oxygen Therapy The results were increased levels of vascular endothelial growth factor (VEGF) and interleukine-6 (IL-6), and lower levels of endothelin-1. These facts ...

8. emedicine.medscape.com emedicine.medscape.com/article/1464149-overview

Hyperbaric Oxygen Therapy Hyperoxia in normal tissues causes vasoconstriction, but this is compensated by increased plasma oxygen content and microvascular blood flow.