Blood gas tension

New Study Finds Significant Correlation Between Masimo ORi™ and Arterial Partial Pressure of Oxygen During One-Lung Ventilation

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Lunedì, Dicembre 11, 2023
Biotechnology, Surgery, Health, Pharmaceutical, Health Technology, Odds ratio, Samsung Medical Center, De novo, Blood, OLV, Sungkyunkwan University, Hypoxemia, Risk, MASI, Patient, Multimedia, Journal, FDA, Hyperoxia, Oxygen, Blood gas tension, Perioperative, Ori, Oxygen saturation (medicine), Receiver operating characteristic, Medical device, Medical imaging, Anesthesia, ROC

ORi is trended continuously with SpO2 as a unit-less index between 0.00 and 1.00 to extend the visibility of the patient oxygenation beyond SpO2 under supplemental oxygen.

Key Points: 
  • ORi is trended continuously with SpO2 as a unit-less index between 0.00 and 1.00 to extend the visibility of the patient oxygenation beyond SpO2 under supplemental oxygen.
  • During anesthesia, ORi was monitored using Masimo RD rainbow SET® Pulse CO-Oximetry sensors, and blood gas analysis was performed 15 minutes after OLV was initiated.
  • Of the 11 potential predictors for PaO2
  • The researchers concluded, “ORi values during one-lung ventilation were significantly correlated with PaO2 measured simultaneously.

Masimo ORi™ Granted De Novo as the First and Only FDA-Cleared Noninvasive and Continuous Parameter to Provide Insight into Hyperoxia Under Supplemental Oxygen

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Venerdì, Ottobre 13, 2023
Surgery, Medical Devices, Hospitals, Health, Health Technology, Linda, Multimedia, MASI, Desaturation, De novo, US, University of Utah, De novo gene birth, MD, Ori, Motion, Blood gas tension, Apnea, University, Hyperoxia, Intensive care medicine, American Medical Association, FDA, CE marking, Masimo, Oxygen, Oxygen saturation (medicine), Anesthesia & Analgesia, Pulse, Airway management, Patient, Medical device, Compact Disc manufacturing, RD, Anesthesia, Anesthesiology, Pain management

Masimo (NASDAQ: MASI) today announced that ORi™, a noninvasive, continuous parameter designed to provide additional insight into a patient’s oxygen status in the moderate hyperoxic range under supplemental oxygen, has been granted a De Novo by the FDA.

Key Points: 
  • Masimo (NASDAQ: MASI) today announced that ORi™, a noninvasive, continuous parameter designed to provide additional insight into a patient’s oxygen status in the moderate hyperoxic range under supplemental oxygen, has been granted a De Novo by the FDA.
  • Enabled by the multi-wavelength Masimo rainbow® Pulse CO-Oximetry platform, ORi is designed for use in conjunction with oxygen saturation (SpO2) to provide increased resolution of changes in oxygenation under supplemental oxygen.
  • View the full release here: https://www.businesswire.com/news/home/20231013679815/en/
    Without ORi, there is no noninvasive way to monitor oxygenation under supplemental oxygen to manage hyperoxia, or higher than normal oxygenation of arterial blood.
  • By convention, SpO2 is limited to an upper limit of 100%, but oxygenation can rise into hyperoxia when supplemental oxygen is administered.

New Study Evaluates the Utility of Masimo ORi™ in Reducing Hyperoxemia During Laparoscopic Gastrectomy

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Martedì, Febbraio 21, 2023
Biotechnology, Surgery, General Health, Health, Medical Devices, Hospitals, Health Technology, Clinical Trials, Fraction of inspired oxygen, Ori, Oxygen saturation (medicine), Patient, General surgery, Oxygen, Anesthesia, Mercury (element), Risk, MASI, FDA, Multimedia, Incidence, Blood gas tension, Medical device, Medical imaging, Medicine

The researchers found that the combination of ORi and standard of care oxygen saturation (SpO2) monitoring reduced hyperoxemia compared to SpO2 monitoring alone.1

Key Points: 
  • The researchers found that the combination of ORi and standard of care oxygen saturation (SpO2) monitoring reduced hyperoxemia compared to SpO2 monitoring alone.1
    This press release features multimedia.
  • Enabled by the multi-wavelength rainbow® Pulse CO-Oximetry platform, ORi is provided alongside SpO2 measured by clinically proven Masimo SET® pulse oximetry.
  • In addition to Masimo ORi and SET® SpO2, Masimo PVi® (pleth variability index) was monitored as part of goal-directed fluid management.
  • The rate of severe hyperoxemia was higher in the SpO2 group (84.4%) than in the ORi-SpO2 group (16.7%) 1 hour after incision (p

Mallinckrodt Announces Submission of 510(k) to the U.S. FDA for Inhaled Nitric Oxide Delivery System

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Mercoledì, Settembre 28, 2022
Autoimmunity, Rheumatology, Risk, NICU, Safety, Blood gas tension, Investor relations, NO2, FDA, Nitric oxide, Food, Sale, Blood, Ophthalmology, Nephrology, Biological functions of nitric oxide, Company, Analgesic, Immunotherapy, Patient, Regulation of tobacco by the U.S. Food and Drug Administration, Inhalation, Extracorporeal membrane oxygenation, Pulmonary edema, U.S. Securities and Exchange Commission, Automation, Annual report, Neurology, Nitrogen dioxide, Ajman Specialty General Hospital, SEC, INO, Pulmonary hypertension, Methemoglobin, Pharmaceutical industry, Mallinckrodt, Methemoglobinemia

DUBLIN, Sept. 28, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced the submission of a 510(k) premarket notification application to the U.S. Food and Drug Administration (FDA) for an investigational inhaled nitric oxide delivery system for INOmax® (nitric oxide) gas, for inhalation.

Key Points: 
  • DUBLIN, Sept. 28, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced the submission of a 510(k) premarket notification application to the U.S. Food and Drug Administration (FDA) for an investigational inhaled nitric oxide delivery system for INOmax (nitric oxide) gas, for inhalation.
  • The safety and efficacy of the investigational inhaled nitric oxide delivery system has not been evaluated by the FDA.
  • The investigational inhaled nitric oxide delivery system is not available for sale, distribution or use.
  • This release includes forward-looking statements concerning Mallinckrodt's s 510(k) premarket notification application and the Company's inhaled nitric oxide delivery system.

Diffusion Pharmaceuticals Completes Dosing in Altitude Trial

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Lunedì, Aprile 11, 2022
Company, Private Securities Litigation Reform Act, Risk, Undersea and Hyperbaric Medical Society, Particular, Hypoxia, NASDAQ, Trial of the century, Compliance, Diffusion, Blood gas tension, Physiology, VO2, Underwater environment, Food, Tissue, Oxygen, Industry, Exertion, U.S. Securities and Exchange Commission, Altitude, TSC, COVID-19, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GLOBE, Annual report, Volunteering, Pharmaceutical industry, Medical imaging, Nasdaq

CHARLOTTESVILLE, Va., April 11, 2022 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) (“Diffusion” or the “Company”), a biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, today announced the final participant has completed dosing in its Altitude Trial.

Key Points: 
  • CHARLOTTESVILLE, Va., April 11, 2022 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) (Diffusion or the Company), a biopharmaceutical company developing novel therapies that enhance the bodys ability to deliver oxygen to areas where it is needed most, today announced the final participant has completed dosing in its Altitude Trial.
  • I would like to express our gratitude to the esteemed investigators and the participants in this clinical study, said Chris Galloway, M.D., Chief Medical Officer of Diffusion.
  • Topline, unblinded data from the Altitude Trial will be available within two months.
  • Diffusion Pharmaceuticals Inc. is a biopharmaceutical company developing novel therapies that enhance the bodys ability to deliver oxygen to areas where it is needed most.

Endpoint Health Presents Published Results from a Retrospective Study of Adult ARDS Patients, Identifying an Innovative Approach to Predicting Clinical Outcomes

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Giovedì, Gennaio 6, 2022
Biotechnology, Health, Clinical Trials, Other Health, OH, Blood gas tension, Blood, Genetically modified bacteria, Safety, Rajneesh Duggal, Oxygen, Health, Fraction of inspired oxygen, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Respiratory rate, Doctor of Philosophy, Â, Therapy, Review, Inhalation, Research, Injury, Patient, Adult, Bilirubin, Ventilation, Cleveland Clinic, BMJ, BMJ Open, Acute pancreatitis, Sepsis, Social, Partial pressure, Twitter, American Thoracic Society, Disease, MD, Department, Cleveland, Creatinine, Inflammation, Mortality, Rheumatoid arthritis, Endpoint, Heart rate, Chest injury, Social media, Pneumonia, Survivor, Critical Care Medicine (journal), Acute respiratory distress syndrome, Pharmaceutical industry, Medical imaging, Medical device, Dietary supplement, the Study, ARDS, Endpoint Health, THE STUDY, ARDS, ENDPOINT HEALTH

The clinical utility of subphenotypic assessment in ARDS would require validation in a prospective clinical study.

Key Points: 
  • The clinical utility of subphenotypic assessment in ARDS would require validation in a prospective clinical study.
  • In current clinical practice, risk stratification for patients with ARDS solely depends on the PaO2/FiO2 clinical measure.
  • The retrospective analysis drew on data from six randomized clinical trials in adult patients with ARDS (five U.S. and one international study).
  • Identification of acute respiratory distress syndrome subphenotypes de novo using routine clinical data: a retrospective analysis of ARDS clinical trials.

Diffusion Pharmaceuticals Doses First Participants in Altitude Trial

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Lunedì, Novembre 22, 2021
Volunteering, Private Securities Litigation Reform Act, Tissue, Exertion, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Industry, Annual report, Company, Exercise, Compliance, Altitude, Blood, COVID-19, U.S. Securities and Exchange Commission, Hypoxia, VO2, Research, Risk, GLOBE, Oxygen, TSC, Blood gas tension, NASDAQ, Food, Particular, Pharmaceutical industry, Medical imaging

(NASDAQ: DFFN) (Diffusion or the Company), a biopharmaceutical company developing novel therapies that enhance the bodys ability to deliver oxygen to areas where it is needed most, today announced it has dosed the first participants in its Altitude Trial.

Key Points: 
  • (NASDAQ: DFFN) (Diffusion or the Company), a biopharmaceutical company developing novel therapies that enhance the bodys ability to deliver oxygen to areas where it is needed most, today announced it has dosed the first participants in its Altitude Trial.
  • Diffusion intends to enroll 30 healthy volunteers and give each volunteer a single dose of TSC at one of three different doses.
  • The Altitude Trial is the second in a series of three, short-term studies Diffusion is conducting intended to provide the Company with additional information regarding TSCs mechanism of action and dose-response characteristics.
  • Diffusion Pharmaceuticals Inc. is a biopharmaceutical company developing novel therapies that enhance the bodys ability to deliver oxygen to areas where it is needed most.

Diffusion Pharmaceuticals Reports Third Quarter Financial Results and Provides Business Update

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Mercoledì, Novembre 10, 2021
Hypoxia, Cancer, Industry, Food, COVID-19, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Public expenditure, Partial pressure, TCOM, American Cancer Society, Exertion, Blood gas tension, ILD, Risk, Seventh Avenue station (IND lines), Efficiency, Altitude, Volunteering, Nephrology, Plasma, Tissue, Trial of the century, Research, GLOBE, Cardiology, Patient, FDA, Particular, Adult, Compliance, Private Securities Litigation Reform Act, TSC, U.S. Securities and Exchange Commission, Marginal cost, NASDAQ, CEO, Tumor hypoxia, Disease, Investigational New Drug, Neurology, VO2, Program, Diffusion Pharmaceuticals, Carbon monoxide, Blood, Annual report, Company, Oxygen, DLCO, Critical care, Pharmaceutical industry, Medical imaging

CHARLOTTESVILLE, Va., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) (Diffusion or the Company), a biopharmaceutical company developing novel therapies that enhance the bodys ability to deliver oxygen to areas where it is needed most, today announced financial results for the third quarter of 2021 and provided a business update.

Key Points: 
  • CHARLOTTESVILLE, Va., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) (Diffusion or the Company), a biopharmaceutical company developing novel therapies that enhance the bodys ability to deliver oxygen to areas where it is needed most, today announced financial results for the third quarter of 2021 and provided a business update.
  • We believe this is an exciting time for Diffusion Pharmaceuticals.
  • Diffusion anticipates initiating the ILD-DLCO Trial late in the fourth quarter of 2021 and completing the trial in the first quarter of 2022, with topline results reported within two months of study completion.
  • General and administrative expenses were $1.9 million during the third quarter of 2021 versus $2.1 million in the comparable quarter last year.

Diffusion Pharmaceuticals Reports Q2 Financial Results and Provides Business Update

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Mercoledì, Agosto 11, 2021
Particular, Industry, VO2, Complete blood count, Partial pressure, CEO, Carbon monoxide, ILD, Company, Patient, Glioblastoma, Annual report, Efficiency, TCOM, Private Securities Litigation Reform Act, Risk, U.S. Securities and Exchange Commission, TSC, Tissue, Blood gas tension, Volunteering, COVID-19, Interstitial lung disease, Plasma, DLCO, Hypoxia, Brain, NASDAQ, Disease, GLOBE, Research, Oxygen, Growth, Exertion, Pharmaceutical industry, Medical imaging

We met our key milestones for the first half of 2021, completing and announcing topline results from our COVID-19 Trial and the first of our Oxygenation Trials.

Key Points: 
  • We met our key milestones for the first half of 2021, completing and announcing topline results from our COVID-19 Trial and the first of our Oxygenation Trials.
  • In May 2021, Diffusion reported final results from its Phase 1b trial (the COVID-19 Trial) of trans sodium crocetinate (TSC) in hospitalized COVID-19 patients.
  • Diffusion anticipates initiating and completing the Altitude Trial in the fourth quarter of 2021, with topline results available within one to two months of study completion.
  • Diffusion Pharmaceuticals Inc. is an innovative biopharmaceutical company developing novel therapies that enhance the bodys ability to deliver oxygen to areas where it is needed most.