Oxygen Gas for Inhalation for Respiratory Insufficiency
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Must not be taking: Opioids
Disqualifiers: COPD, Neurological, Cardiopulmonary, Psychiatric, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
In this randomized-controlled trial the investigators will examine the effect of oxygen supplementation on the recovery of breathing for 90 minutes in the immediate post-anesthesia period starting from extubation of the trachea.
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.
What data supports the effectiveness of the treatment Oxygen Gas for Inhalation for Respiratory Insufficiency?
The research indicates that oxygen therapy is essential for treating respiratory insufficiency when there is a significant lack of oxygen in the blood (hypoxemia), especially when levels are critically low. It is most effective when used in controlled and dosed amounts for patients with severe respiratory issues.12345
Is oxygen gas safe for inhalation in humans?
How is the treatment 'Oxygen Gas for Inhalation' unique for respiratory insufficiency?
Oxygen Gas for Inhalation is unique because it provides controlled, continuous oxygen through a nasopharyngeal catheter, which helps improve oxygen levels and overall respiratory function without the risk of worsening respiratory depression. This method allows for safe home use, unlike some other treatments that may require hospital settings.3491112
Eligibility Criteria
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
Trial Timeline
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
Treatment Details
Interventions
- Oxygen Gas for Inhalation (Gas)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: "Liberal O2 Supplementation"Experimental Treatment1 Intervention
Oxygen administration will be titrated to an SpO2 \> 96%.
Group II: "Conservative O2 Supplementation"Active Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford University School of MedicineStanford, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
References
Inhaled nitric oxide to improve oxygenation for safe critical care transport of adults with severe hypoxemia. [2020]Inhaled nitric oxide (iNO) is a rescue treatment for severe hypoxemia in the intensive care unit setting.
[Computed tomographic criteria as expected effect to inhaled nitric oxide in patients with severe acute respiratory distress syndrome]. [2020]Inhaled nitric oxide (iNO) is an effective therapy for severe hypoxemia in most patients with acute respiratory distress syndrome (ARDS). For unknown reason, a subset of ARDS patients does not respond favorably to iNO therapy. We hypothesized that radiological manifestation of lung injury may be related to iNO response.
Inhaled Nitric Oxide Use and Outcomes in Critically Ill Children With a History of Prematurity. [2023]Inhaled nitric oxide (INO) is used to treat hypoxic respiratory failure without clear evidence of benefit. Future trials to evaluate its use will be designed based on an understanding of the populations in which this therapy is provided and with outcomes based on patient characteristics, for example, a history of premature birth.
A quality improvement project improving the value of iNO utilization in preterm and term infants. [2021]Inhaled NO (iNO) is used in the NICU for management of hypoxemic respiratory failure. The cost of iNO is significant and does not consistently improve outcomes in infants
[Indications and contraindications for oxygen therapy of respiratory insufficiency]. [2009]After a critical review of the different opinions, the author differentiates the indications for oxygen treatment of respiratory insufficiency to subjective and objective based on his own experience following a clinical observation of 100 patients with exacerbated chronic respiratory insufficiency, subjected to dosed, controlled and continuous oxygen therapy. The most essential objective indication for oxygen treatment is the manifestation of hypoxemia degree without or with CO2 retention. According to hypoxemia manifestation, determined by PaO2 level, the indications are absolute (with PaO2 under 40 mm Hg), urgent (with PaO2 under 30 mm Hg) and relative (with PaO2 over 50 mm Hg). The application of oxygen treatment with PaO2 over 700 mm Hg as well as the so called "preventive" O2 treatment (with no hypoxemia) is improper with a view to possible harmful side effects of oxygen. Oxygen treatment is contraindicated in all patients with unfavourable ventilation response to oxygen treatment. In case of non-effective O2 treatment (unfavourable ventilation response resp.) mechanical ventilation must be turned to as well as in all cases with patients in respiratory coma.
Prehospital pharmacology: nitrous oxide. [2017]Nitrous oxide is a potent inhalational anesthetic/analgesic that is safe and effective for out-of-hospital use. It is a regulated drug that must be purchased and prescribed by a physician. Thus, its use will be limited to those EMS systems where it is allowed by local, regional or state formulary and approved by the system medical director.
Use of Entonox in the community for control of procedural pain. [2019]Nitrous oxide gas, mixed 50:50 with oxygen, is an effective and safe analgesic which, although widely used in many areas of clinical practice, has not been fully recognized in the community setting for painful procedures. The reasons why it has not been implemented and used to the patient's advantage have been suggested as apathy, lack of confidence, lack of knowledge and lack of resources. The author describes how, following a review of the literature pertaining to its use in other clinical areas, she has successfully introduced nitrous oxide/oxygen into her trust, with positive results.
[Premixed 50% nitrous oxide and oxygen: theoretical recalls and practical modalities]. [2017]The concept of premixed 50% nitrous oxide and oxygen dated back to 1961 in England, where it is commercialised under the name Entonox. In France, after a so marginal use, premixed 50% nitrous oxide and oxygen now knows such a revival since we first consider the pain provoked by the cure. To use correctly premixed 50% nitrous oxide and oxygen, we need to know the main properties of the nitrous oxide. The four commercial versions, now on the market, are presented (Kalinox, Medimix, Antasol, Oxynox. Except a few contraindications, these indications are large, as well at hospital as outside. In less than 10% of the cases, side effects are possible. Conditions of administration are given in details. The limits of the technic and the particular precautions of use are precised.
Decompression sickness risk at 6553 m breathing two gas mixtures. [2019]The risk of severe decompression sickness (DCS) increases rapidly above 6248 m (20,500 ft) and is greater when breathing higher proportions of inert gas. Contemporary aircrew may be exposed to higher cabin altitudes while breathing molecular sieve oxygen concentrator (MSOC) product gas containing variable concentrations of oxygen, nitrogen, and argon. This study assessed the risk of DCS at 6553 m (21,500 ft) breathing two simulated MSOC product gas mixtures.
Nitrous oxide sedation/analgesia in emergency medicine. [2019]Nitrous oxide:oxygen mixtures are safe and effective sedative/analgesic agents for use in emergency medicine. They are suitable for prehospital care because of their safety, rapid onset, and short duration of action. The self-administered form of a 50:50 mixture is the most acceptable system, but other methods of administration should be investigated, particularly in the ED setting. While there are unresolved questions concerning the use of nitrous oxide as an anesthetic and analgesic agent, it is difficult to extrapolate many of the findings to the low-dose, patient-controlled 50:50 mixture used in emergency medicine. Use of the gas mixture in a variety of clinical settings has been associated with no major adverse occurrences, and experience continues to support its safety. Future possibilities for study include the use of the gas mixture in combination with other agents or TENS. No one drug can be considered a panacea for all painful states. Nitrous oxide:oxygen mixtures certainly do not meet all the criteria for the ideal analgesic. Those clinicians who seek a safe and effective sedative/analgesic for mild to moderate pain will be satisfied that we can now offer more to our patients in the early management of their problems.
Therapeutic gases for neonatal and pediatric respiratory care. [2016]Though oxygen is the most frequently administered gas in respiratory care, the use of other specialty gases has become common practice in neonatal and pediatric intensive care and emergency departments across the United States. This report reviews the literature and evidence regarding 4 such specialty gases: heliox (helium-oxygen mixture), nitric oxide, hypoxic gas (ie,
[Adaptation to oxygen breathing]. [2013]Controlled, dosed, uninterrupted and continuous oxygen treatment was applied in 63 patients with global respiratory insufficiency, through a nasopharyngeal catheter in concentrations to 30 per cent. PaO2, is elevated with and average of 12 mm mercury column after 30 minutes 25% oxygen breathing and PaCO2--at an average of 8 mm mercury column. PaO2 level was kept after 24 hours whereas PaCO2 decreased at an average of 4 mm mercury column. Besides, respiration and pulse rate are decelerated, secondary polyglobulia decreases, cardiac and renal function is improved. Those changes are interpreted as patients' adaptation to oxygen breathing. The adaptation to oxygen breathing decreases the danger of critical intensification of the respiratory depression in the course of the treatment and conditions for a successful application of O2 treatment at home are created.