Phase 1 N=16 Reoxygenation After Cardiac Arrest II (REOX II Study)
Cardiac Arrest
Primary: Plasma Isofurans (pg/mL)/Isoprostanes (pg/mL) Ratio
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=201 Risk of Oxygen During Cardiac Surgery Trial
Cardiac Surgery
Primary: Intraoperative Systemic Oxidative Damage — 69; 83 pg/ml
N/A N=29 Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period
Hypoplastic Left Heart Syndrome · Total Anomalous Pulmonary Venous Return · Truncus Arteriosus
Primary: Systemic Oxidative Stress Based on Thiobarbituric Acid Reactive Substances (TBARS) — 1.21; 1.93; 1.09; 1.77 Fold Change from Baseline — p=<0.01
N/A N=212 Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate
Intrauterine Resuscitation
Primary: Umbilical Artery Malondialdehyde — 9.8; 10.2 umol/L
Phase 3 N=100 Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?
Atelectasis
Primary: Oxygen Requirement to Maintain SpO2>90% — 1; 1; 1; 1 liters per minute
Phase 2 N=96 Normobaric Hyperoxia for Intracerebral Hemorrhage
Normobaric Hyperoxia · Intracerebral Hemorrhage
Primary: Percentage of Patients With mRS 0-3 — 39; 27 Participants
N/A N=114 Oxygen for Intrauterine Resuscitation of Category II Fetal Heart Tracings
Electronic Fetal Monitoring · Fetal Hypoxia · Fetal-Placental Circulation
Primary: Mean Umbilical Artery Lactate at Delivery — 3.5; 3.4 mmol/L — p=0.69
N/A N=31 Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
Respiratory Distress Syndrome in Premature Infants · Very Low Birth Weight Baby
Primary: Maximum Factional Inspired Oxygen Percent (FiO2) — 48; 39 percentage of Inspired Oxygen — p=0.0012
N/A N=1,301 Pragmatic Trial Examining Oxygenation Prior to Intubation
Acute Respiratory Failure
Primary: Incidence of Hypoxemia — 57; 118 Participants
Phase 4 N=33 Neuroimaging During Pure Oxygen Breathing
Hyperoxia · Hypoxia, Brain · Neurobehavioral Manifestations
Primary: Cerebral Blood Flow — 48.54; 36.17 ml/min/100g tissue — p=<0.05
Phase 2 N=19 High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients
Cancer
Primary: Change in Dyspnea Numeric Score Between 0 and 10 Minutes — -1.8; -1.8; -0.6; -0.5 score on a scale
N/A N=37 Preoxygenation With Nasal Cannula and Noninvasive Positive Pressure Ventilation
Hypoxia
Primary: End-tidal Oxygen — 78.1; 78.6 End tidal oxygen saturation percentage
N/A N=150 Preoxygenation With Positive Inspiratory Pressure During Induction of Anesthesia
Anesthesia
Primary: Time for Preoxygenationfrom Face Mask Positioning to FEO2=90% — 190; 153; 140 seconds
N/A N=31 Correlation of Changes in PaO2 and ORi in Adult Patients
Hyperoxia
Primary: Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. — 100 percentage of true positives
N/A N=70 Supplemental Oxygen Study
Cesarean Section · Supplemental Oxygen · Umbilical Cord Gases
Primary: Umbilical Cord pH Levels — 7.29; 7.28 pH
N/A N=60 Effect of Super-Oxygenated Water on Blood Oxygen Saturation
Adult Subject
Primary: SpO2 Response Rate — 21; 11 Participants — p=0.010
Phase 3 N=738 Long-term Oxygen Treatment Trial
Chronic Obstructive Pulmonary Disease
Primary: Death or Hospitalization, Whichever Occurs First — 34.2; 36.4 Composite events/100 person-years — p=0.52
N/A N=29 Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00025
Healthy
Primary: Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. — 99.68; 92.94; 91.48 percentage of accuracy
N/A N=29 Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029
Healthy
Primary: Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values — 99.4; 89.74; 89.86 percentage of accuracy
N/A N=49 Prevention of Opioid-Induced Hypoxemia
Non-cardiac Surgery
Primary: Time-weighted Average of SpO2 Below a Threshold of 90% — 0.29; 0.11; 0.16; 0.10 % of SpO2 — p=0.120
N/A N=40 Pre-Oxygenation Techniques in Pregnancy
Preoxygenation
Primary: End Tidal Oxygen Concentration (ETO2) Following Tidal Volume Breathing Using Either Face Mask or OptiFlow — 91.0; 87.4 Percentage units of end-tidal oxygen
N/A N=19 Supplemental Oxygen in Pulmonary Fibrosis
Pulmonary Fibrosis
Primary: Change in University of California San Diego Shortness of Breath Questionnaire From Immediately Prior to One Month After Starting Daily-use Supplemental Oxygen — 0.9…
N/A N=27 Oxygen Reserve Index (ORi) Validation of INVSENSOR00025
Healthy
Primary: Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. — 94.82; 90.69; 100 percentage of true negatives
N/A N=30 Oxygen Reserve Index (ORi) Validation of INVSENSOR00029
Healthy
Primary: Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. — 93.63 percentage of true positives
N/A N=572 Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients
Trauma · Critical Illness · Oxygen Toxicity
Primary: Patient-time Hyperoxic and Not on Room Air — 40.6; 33.9 Percent patient-time in hyperoxia — p=0.03
N/A N=196 A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants
Premature Infants
Primary: Duration of Home Oxygen Therapy — 66; 58 Days — p=<0.03
N/A N=2,541 Pragmatic Investigation of optimaL Oxygen Targets Trial
Respiratory Failure
Primary: Ventilator-free Days (VFDs) to Study Day 28 — 20; 21; 21 number of days
Phase 3 N=136 Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
Idiopathic Pulmonary Arterial Hypertension · Cardiomyopathy
Primary: Number of Participants With Reversible Pulmonary Hypertension (Vasoreactivity) — 28; 16 Participants
Phase 2 N=20 Hyperbaric Oxygen Therapy for Lung Transplantation
Disorder Related to Lung Transplantation · Central Airway Stenosis · Airway Exudative Plaques
Primary: Subjects Needing Airway Stent Placement as Determined by Transbronchial Lung Biopsy. — 4; 4 Participants — p=1
N/A N=34 Preoxygenation With Optiflow™ - the Effect of Speech on Lung Oxygenation.
Unrecognized Condition
Primary: End Tidal Oxygen Fraction — 43.9; 81.9 percentage of End-Tidal Oxygen Fraction