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Hypoxia clinical trials

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NCT ID: NCT05807477 Recruiting - Hypoxia Clinical Trials

Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO19)

Start date: April 18, 2023
Phase:
Study type: Observational

The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.

NCT ID: NCT05807464 Recruiting - Hypoxia Clinical Trials

Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO18)

Start date: April 10, 2023
Phase:
Study type: Observational

The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.

NCT ID: NCT05790616 Recruiting - Hypoxia Clinical Trials

Accuracy of Pulse Oximeters During Profound Hypoxia

APO
Start date: January 28, 2023
Phase: N/A
Study type: Interventional

This study is designed to calibrate and determine the accuracy for SpO2, pulse rate and respiratory rate of the newly in-house build Test Device wrist 1 (TDw1, or EVA) at Philips. SpO2, pulse rate and respiratory rate during hypoxia will be calculated by using data of well-known reference devices, including: - A reference SpO2 sensor of Nellcor placed at a fingertip, that reflects also continuously the pulse rate Will be used to compare with the test device. - A reference respiratory rate device that calculates the respiratory rate based on detection of end-tidal CO2 peaks by capnography. - Oxygen saturation in arterial blood samples (SaO2), determined by a co-oximeter will be used to calculate the accuracy of the test device. During the study the following devices will be additionally used by the volunteers: - AppleWatch 7 - TDw2, watch build by philips, using the PPG and software technology developed by Philips - A smartphone that detects reflected PPG signals from the reflected screen at the handpalm, by the build in frontfacing camera (TDc) of the smartphone Volunteers will undergo progressive hypoxia (9 min/% O2) from 21 to 10% O2 in an altitude room, resulting in a volunteer's SpO2 of 73%. During this deliberated hypoxia, the volunteers wear the test and reference devices. This study consists of 4 sub-studies (NI = non-invasive; IN = invasive with an arterial line): - NI (Fast-Sitting): volunteers are seated in the hypoxia room in which the ambient oxygen concentration decreases at a speed of 9 min/% O2. If the volunteer reached a SpO2 ≤73% for more than 1 minute, he/she leaves the hypoxia room. And will breath air with 21% oxygen. Volunteers wear TDw1 and TDw2 and the reference devices. - NI(Fast-Lying): identical to NI(Fast-Sitting) but volunteers lay on a mattress. Volunteers wear TDw1 and AppleWatch 7 and the reference devices. - NI (Slow-Sitting): identical to NI (Fast-Sitting), but after one of the volunteers reaches a SpO2 ≤73% for more than one minute, oxygen in the room increases at a speed of 9 min/% O2 until normal ambient air oxygen concentration of 21%. Volunteers wear TDw1 and AppleWatch 7 and the reference devices. - IN(Fast-Sitting): identical to NI(Fast-Sitting) but the volunteer's oxygen saturation in blood samples withdrawn via an arterial line is measured in the laboratory. The NI studies include 18 healthy participants in each sub-study. After the first volunteers have completed the study, small adaptations in the software of the study devices is still possible, e.g. to increase the quality of the PPG-signals. After the three sub-studies are completed, the algorithm for conversion of raw PPG signals to SpO2, pulse rate and respiratory rate will be defined and fixed for the test devices. During the IN-study, which can only be started after completion of all NI studies, an arterial catheter will be inserted in the radial artery of the 12 participating volunteers, in order to take several blood samples to measure oxygen saturation in the blood (25 samples at well-defined moments during the study per volunteer). Using these results of arterial oxygen saturation, the accuracy of the test devices can be calculated.

NCT ID: NCT05787899 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

Hypothermia's Effect on Hepatitis B Vaccination

Start date: May 18, 2023
Phase:
Study type: Observational

The purpose of the research is to determine if the Hepatitis B vaccine after birth provides enough protection after cooling for Hypoxic Ischemic Encephalopathy (HIE). To do this, Hepatitis B titers (blood sample) would be taken before, during, and after administering of the Hepatitis B vaccine series to measure efficacy of the vaccine.

NCT ID: NCT05783050 Recruiting - Airway Obstruction Clinical Trials

Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support in Gastrointestinal Endoscopy Patients

Start date: March 30, 2023
Phase: N/A
Study type: Interventional

Sedoanalgesia is applied to patients during gastrointestinal endoscopy. Sedoanalgesia may cause respiratory depression and hypoxia in patients. During these procedures, patients should be given oxygen support to reduce the incidence of hypoxia.This study aimed to compare the efficacy and procedural performance of two different airway devices (Wei Nasal Jet Tube vs Nasal Cannula Oxygen Support) in Gastrointestinal Endoscopy

NCT ID: NCT05782478 Recruiting - Hypoxia Clinical Trials

Added Diagnostic Value of Point of Care Ultrasound in Acute Dyspnea

Start date: March 9, 2023
Phase:
Study type: Observational

Dyspnea is a common diagnostic challenge in the Emergency Department (ED). Delay in diagnosis will increase time to correct treatment and could impact outcome. Previous studies have shown excellent diagnostic performance of point of care ultrasound (POCUS) to detect and differentiate between several important diagnosis (e.g heart failure and pneumonia) in patients with dyspnea. However, in most studies POCUS is performed by physicians highly experienced in ultrasound and often studies have focused only on one or few diagnoses. The aim of this study is to compare the diagnostic accuracy of different diagnosis in dyspnoeic patients before and after a ED physician with limited training applies POCUS.

NCT ID: NCT05778188 Recruiting - Clinical trials for Hypoxic-Ischemic Encephalopathy

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia

STAR
Start date: July 27, 2023
Phase: Phase 2
Study type: Interventional

Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant neurocognitive disability. Despite this vital unmet medical need, no pharmacological adjunct or alternative therapy has proven beneficial in improving outcomes in neonatal HIE. RLS-0071 is a novel peptide being developed for the treatment of neonatal HIE. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of newborns with moderate or severe HIE.

NCT ID: NCT05767476 Recruiting - Clinical trials for Encephalopathy, Hypoxic Ischemic

Neurodevelopmental Outcome in Newborn With Hypoxic-ischemic Encephalopathy Treated With Therapeutic Hypothermia

Start date: April 28, 2021
Phase:
Study type: Observational

The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia. The main questions it aims to answer are: - Identify patients at risk of neuromotor, cognitive and epileptic sequelae - Plan early rehabilitation programs and future trials on early neuroprotection in infant at risk of neurodevelopmental disability Participants will be involved in serial assessment: - Before and after therapeutic hypothermia and before discharge: neurological assessment, according to the modified Sarna (t) score, Thompson's score and Hammersmith Neonatal Neurological Examination (HNNE); General Movement Assessment - Amplitude integrated electroencephalogram (aEEG) within 6 hours of life, for 6 hours. - Neonatal Cranial Ultrasonography within 6 hours of life, in the third and seventh day of life. - Brain magnetic resonance imaging between 7 and 14 days. - Electroencephalogram (EEG) within 7 days. After discharge study population will perform: - EEG between 3 and 6 months. - Neurological assessment using Hammersmith Infant Neurological Examination (HINE) at 3-6-9-12 months. - General Movement Assessment at 3 months. - Neurodevelopmental assessment using the Griffiths Mental Development Scales at 24 months. - Cognitive assessment using the Wechsler Preschool and Primary Scale of Intelligence between 36 and 41 months. - Motor performance assessment using Movement ABC between 42 and 48 months.

NCT ID: NCT05767385 Recruiting - Hypoxia Clinical Trials

Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior

Start date: December 17, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Determine 1) the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay (ND) outcomes and 2) how this relationship is modified by patient and environmental factors such as chronic congenital heart disease (CCHD) lesion, maternal-fetal environment, and social determinants of heath (SDOH) in a diverse population using a multicenter design. Pregnant women will be approached during one of their fetal cardiology clinic visits.

NCT ID: NCT05764018 Recruiting - Hypoxia Clinical Trials

Caffeine and Hypoxia During Exercise in Males and Females

HypoCaff
Start date: March 6, 2023
Phase: N/A
Study type: Interventional

Several high-altitude destinations recommend their visitors to avoid caffeine, theoretically due to the associated diuresis which could contribute to acute mountain sickness. There is however no direct evidence for this association. In fact, caffeine ingestion is known to improve exercise performance at sea level, and may therefore help mountaineers during expeditions. Sport science research is largely conducted in male participants, and the findings from these studies are assumed to apply to the female population. Given the known sex differences in body composition, hormones, and other physiological factors, this may not be appropriate. It is therefore important to conduct research in women, to allow for female-specific recommendations.