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Oxygen Deficiency clinical trials

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NCT ID: NCT03185507 Completed - Cryotherapy Effect Clinical Trials

The Effect of Cryotherapy on Cerebral Hemodynamics Within Healthy Subjects

Start date: March 22, 2017
Phase: Phase 1
Study type: Interventional

Upon suffering a concussion, a neurometabolic cascade including an increase in glucose and oxygen demand occurs for up to 48 hours post-insult.5 This period of increased glucose and oxygen demand is coupled with a period of hyperperfusion and decreased cerebral blood flow. 6-9 Cryotherapy in the musculoskeletal system has been shown to decrease tissue temperature, blood flow, oxygen and metabolic demands.10-17 Cryotherapy following moderate or severe traumatic brain injury has been demonstrated to decrease intracranial metabolic processes and oxygenation consumption.18-23 Although the benefits of cryotherapy have been established in moderate-severe TBI, the effects of superficial cranial cooling in individuals with and without concussion are unknown. The purpose of this randomized control trial is to evaluate the effects of superficial cryotherapy on cerebral blood flow and cognitive function in healthy, recreationally active young adults.

NCT ID: NCT03128372 Completed - Oxygen Deficiency Clinical Trials

Validation of Next Generation Cerebral and Tissue Oximeter

Start date: May 22, 2017
Phase: N/A
Study type: Interventional

This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.

NCT ID: NCT03080688 Completed - Oxygen Deficiency Clinical Trials

Prizma Pulse Oximeter Evaluation

Start date: April 15, 2016
Phase: N/A
Study type: Observational

This study is intended to evaluate performance of the new design sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically: - SpO2 value range 70% to 100% - 10 or more subjects, at least 3 of dark pigmentation - At least 200 data points - Meeting the following test required by the 2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions and by ISO 80601-2-61 on Pulse Oximeters: - 2013 FDA Guidance on Pulse Oximeters - Premarket Notification Submissions: - 4.1. ACCURACY OF PULSE OXIMETERS - 4.1.1 IN VIVO TESTING FOR SPO2 ACCURACY UNDER LABORATORY CONDITIONS - ISO 80601-2-61:2011 Annex EE.2 and clause 201.12.1.101.2 - 201.12.1.101 SpO2 accuracy of pulse oximeter equipment - 201.12.1.101.2 Determination of SpO2 accuracy