Oxygen Gas for Inhalation for Respiratory Insufficiency

Overseen By Anthony Doufas, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Opioids

Disqualifiers: COPD, Neurological, Cardiopulmonary, Psychiatric, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 90 minutes

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how oxygen delivery aids breathing recovery immediately after surgery. It compares two methods: one maintains oxygen levels between 90-94%, and the other keeps them above 96%. The goal is to determine which method improves breathing after anesthesia. Suitable participants have a BMI under 40 and are undergoing specific kidney or prostate surgeries. As an unphased trial, this study provides an opportunity to contribute to medical knowledge and potentially enhance post-surgery recovery for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a chronic pain condition treated with opioids, you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that inhaling oxygen gas is generally safe for people. Hospitals often use oxygen therapy to assist those with breathing problems. While excessive oxygen can occasionally cause issues like lung or eye problems, these are rare when administered carefully.

Oxygen is essential for the body to function properly. Without sufficient oxygen, serious issues like organ failure or brain damage can occur. Studies indicate that oxygen use can help prevent these problems by ensuring the body receives the oxygen it needs.

Previous studies have demonstrated that oxygen therapy can improve breathing and aid recovery from severe respiratory issues. Although risks exist if oxygen is not used correctly, it is usually well-tolerated by most patients when properly monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about testing different oxygen supplementation strategies for respiratory insufficiency because it could lead to more personalized and effective care. Unlike the standard approach that typically targets a general range of oxygen saturation, this trial investigates two distinct strategies. The conservative approach titrates oxygen to keep levels between 90 and 94%, potentially reducing the risk of oxygen toxicity. On the other hand, the liberal approach aims for saturation above 96%, which may offer better oxygen delivery to tissues. Understanding which strategy works best could optimize treatment outcomes and improve patient safety.

What evidence suggests that this trial's treatments could be effective for respiratory insufficiency?

Research has shown that oxygen therapy can improve breathing after anesthesia. In this trial, participants will receive either "Conservative O2 Supplementation," with oxygen titrated to maintain an oxyhemoglobin saturation (SpO2) between 90 and 94%, or "Liberal O2 Supplementation," with oxygen titrated to an SpO2 greater than 96%. Studies have found that higher oxygen levels can enhance comfort and may reduce the need for mechanical breathing assistance. Specifically, high-flow oxygen has been linked to better outcomes in patients with various breathing issues. This suggests that increased oxygen might expedite recovery of normal breathing. Overall, evidence supports using oxygen to stabilize breathing in patients with respiratory difficulties. ^{6 7 8 9 10}

Who Is on the Research Team?

Anthony Doufas, MD, PhD

Principal Investigator

Professor, Department of Anesthesiology, Stanford University Medical School

Are You a Good Fit for This Trial?

This trial is for adults in good to moderate health (ASA I-III), with a BMI under 40, who are scheduled for robotic-assisted kidney removal surgery. It's not open to those with chronic lung disease, severe brain/heart/lung conditions, major psychiatric or untreated thyroid issues, chronic pain on opioid treatment, low blood count or significant blood loss during surgery.

Inclusion Criteria

American Society of Anesthesiologists (ASA) physical status I-III

Your body mass index (BMI) is below 40 kg/m2.

You are planning to have a type of kidney surgery called robotic-assisted radical laparoscopic nephrectomy.

Exclusion Criteria

You have been diagnosed with severe COPD, neurological, cardiopulmonary, or psychiatric conditions, or untreated thyroid disorder.

You are currently taking prescription painkillers for a long-term pain problem.

Patients with a hematocrit lower than 30% at the end of surgery, or those with an excessive blood loss, requiring transfusion of blood products during surgery

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either conservative or liberal oxygen supplementation during the 90-minute post-anesthesia period

90 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oxygen Gas for Inhalation

Trial Overview

The study tests if breathing high levels of oxygen after general anesthesia helps patients recover their normal breathing faster. Participants will be randomly assigned to receive extra oxygen or not after they wake up from anesthesia and will be monitored for 90 minutes.

How Is the Trial Designed?

Group I: "Liberal O2 Supplementation" Experimental Treatment 1 Intervention

Oxygen administration will be titrated to an SpO2 \> 96%.

Group II: "Conservative O2 Supplementation" Active Control 1 Intervention

Oxygen administration will be titrated to a oxyhemoglobin saturation (SpO2) between 90 and 94%.

Oxygen Gas for Inhalation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Oxygen for:

• Anoxia
• Hypoxia
• Dyspnea
• Respiratory distress
• Post-anesthesia recovery

Approved in United States as Oxygen for:

• Anoxia
• Hypoxia
• Dyspnea
• Respiratory distress
• Post-anesthesia recovery

Approved in Canada as Oxygen for:

• Anoxia
• Hypoxia
• Dyspnea
• Respiratory distress
• Post-anesthesia recovery

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Inhaled nitric oxide (iNO) was effectively utilized in a NICU setting, leading to a significant reduction in costs per patient from $21,620 to $10,580, demonstrating improved management of hypoxemic respiratory failure.

The quality improvement project not only optimized the use of iNO by ensuring appropriate indications and timely weaning but also successfully implemented these strategies across multiple NICUs, enhancing overall treatment efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quality improvement project improving the value of iNO utilization in preterm and term infants. Fischer, H., Singh, T., Devlin, L., et al.[2021]

Nitrous oxide mixed with oxygen is a safe and effective pain relief option that is underutilized in community settings for painful procedures.

The author successfully implemented the use of nitrous oxide/oxygen in her clinical practice after reviewing existing literature, leading to positive outcomes, highlighting the need for greater awareness and training in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Entonox in the community for control of procedural pain. Evans, A.[2019]

Premixed 50% nitrous oxide and oxygen, known as Entonox, has been effectively used for pain relief since its introduction in 1961, and its use is experiencing a revival in France due to its effectiveness in managing pain during medical procedures.

The use of this gas mixture has a low incidence of side effects (less than 10%), making it a safe option for pain management in various settings, both in hospitals and outside, with specific guidelines for administration and precautions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Premixed 50% nitrous oxide and oxygen: theoretical recalls and practical modalities]. Boulland, P., Favier, JC., Villevieille, T., et al.[2017]

Nitrous oxide:oxygen mixtures are safe and effective for sedation and pain relief in emergency medicine, particularly in prehospital care due to their rapid onset and short duration of action.

The self-administered 50:50 mixture is the most acceptable method, and while it has shown no major adverse effects in various clinical settings, further research is needed to explore its use in combination with other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nitrous oxide sedation/analgesia in emergency medicine. Stewart, RD.[2019]

In a study of 63 patients with global respiratory insufficiency, controlled oxygen treatment significantly improved oxygen levels (PaO2) by an average of 12 mmHg within 30 minutes and maintained these levels over 24 hours.

The treatment also led to a decrease in carbon dioxide levels (PaCO2) by an average of 8 mmHg, along with improved respiratory and cardiac function, suggesting that patients adapted well to the oxygen therapy, making it safer for potential home use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adaptation to oxygen breathing]. Patarinski, D.[2013]

Inhaled nitric oxide (INO) was used in a study of 163 children in the pediatric ICU, showing that early preterm infants (born <32 weeks) had better outcomes, including more ventilator-free days and lower mortality rates compared to late preterm and full-term infants.

The study suggests that INO was initiated for less severe lung disease in early preterm infants, indicating a need for future clinical trials to standardize criteria for starting INO therapy and to consider the history of prematurity when evaluating its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled Nitric Oxide Use and Outcomes in Critically Ill Children With a History of Prematurity. Maddux, AB., Mourani, PM., Banks, R., et al.[2023]

Inhaled nitric oxide (iNO) therapy is more effective in ARDS patients with a greater amount of normal lung tissue surrounding small consolidated areas, as indicated by a significant correlation between the morphology of lung injury and the response to iNO.

Patients who did not respond to iNO therapy had larger, more coherently consolidated lung regions, suggesting that the distribution of lung injury plays a crucial role in the efficacy of iNO treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Computed tomographic criteria as expected effect to inhaled nitric oxide in patients with severe acute respiratory distress syndrome]. Röttgen, R., Busch, T., Lohbrunner, H., et al.[2020]

Oxygen therapy is crucial for treating respiratory insufficiency, particularly indicated by low levels of oxygen in the blood (PaO2), with specific thresholds defining absolute (PaO2 < 40 mm Hg), urgent (PaO2 < 30 mm Hg), and relative (PaO2 > 50 mm Hg) indications based on a study of 100 patients.

Using oxygen therapy when PaO2 is above 70 mm Hg or for preventive measures without hypoxemia can be harmful, and in cases where oxygen treatment is ineffective, mechanical ventilation should be considered, especially for patients in respiratory coma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Indications and contraindications for oxygen therapy of respiratory insufficiency]. Patarinski, D.[2009]

Heliox, a mixture of helium and oxygen, reduces breathing resistance and work, making it beneficial for managing airway obstruction in neonatal and pediatric patients.

Inhaled nitric oxide acts as a selective pulmonary vasodilator, while hypoxic gas and carbon dioxide are used to manage pulmonary and systemic vascular resistance in infants with congenital heart defects, ensuring adequate oxygenation and tissue perfusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic gases for neonatal and pediatric respiratory care. Myers, TR.[2016]

In a study involving 10 subjects exposed to high altitudes of 6553 m (21,500 ft), the risk of decompression sickness (DCS) was found to be 25%, with minor cases occurring after less than 90 minutes, indicating a significant risk for aircrew at these altitudes.

Breathing a gas mixture with 56% oxygen reduced the latency of venous gas emboli (VGE), suggesting that higher oxygen concentrations in the breathing gas can enhance safety and reduce the risk of DCS during high-altitude flights.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decompression sickness risk at 6553 m breathing two gas mixtures. Connolly, DM., Lee, VM., D'Oyly, TJ.[2019]

Nitrous oxide is a safe and effective anesthetic and analgesic for use outside of hospital settings, making it suitable for emergency medical services (EMS).

Its use is regulated and requires a physician's prescription, which means it can only be utilized in EMS systems that have received approval from local or state authorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehospital pharmacology: nitrous oxide. Jaslow, D., Lemecha, D.[2017]

Inhaled nitric oxide (iNO) significantly improved oxygen levels in patients with severe hypoxemia, with arterial oxygen partial pressure (PaO2) increasing from 60.7 to 72.3 mm Hg after treatment (P=.008).

The use of iNO allowed for safe transport of patients to a tertiary care center, with 60.2% of those treated surviving to discharge, compared to a 50% survival rate in patients transported without iNO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled nitric oxide to improve oxygenation for safe critical care transport of adults with severe hypoxemia. Teman, NR., Thomas, J., Bryner, BS., et al.[2020]

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