NCT03980210

Effect of Hyperbaric Oxygen Therapy on Microcirculation

Effect of Hyperbaric Oxygen Therapy on Healthy Volunteers Microcirculation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

Previous studies shoes that hyperoxia alters microcirculation.The investigators hypothesize that hyperbaric may restore microcirculation integrity. This hypothesis is supported by a recent study in rabbits, but no data exists for humans. The study will expose fifteen healthy volunteers to a succession of different fraction of inspired oxygen and barometric pressure and assess microcirculatory and macrocirculatory changes via sidestream dark field videomicroscopy, near-infrared spectroscopy, Laser Doppler, transthoracic echocardiography and bio-impedancemetry at every step.

Detailed description

Microcirculation alterations and hyperoxia are known to alter ICU-patients' prognostic. Studies have shown that hyperoxia alters healthy volunteers' microcirculation, whereas hyperbaric oxygen therapy is commonly used to facilitate cicatrization. There seems to be a paradox. A recent study in rabbits has given some evidences that hyperbaria may restore microcirculation integrity, but to date, there is no such evidences in human. To study hyperoxia and hyperbaric induced changes in micro and macrocirculation, fifteen healthy volunteers will be exposed to successive variations of inspired oxygen fraction and barometric pressure according to a predefine sequence so that only one parameter will change from a condition to the next one : 1. FiO2 0.21 - 1 ATA 2. FiO2 1 - 1 ATA 3. FiO2 1 - 2.5 ATA 4. FiO2 0.21 - 2.5 ATA 5. FiO2 0.21 - 1 ATA At each time, and after a 30 minutes period of exposure, measures will be made using SDF-microscopy, Laser Doppler and NIRS to assess microcirculation. As previously described, macrocirculation can modify microcirculation due to a mechanism called hemodynamic coherence. Hence, the investigators planned to assess macrocirculation changes at every step of the protocol using bioimpedancemetry and transthoracic echocardiography. Each volunteer will be his own control, using the first measurements (condition 1. FiO2 0.21 - 1 ATA) as reference.

Conditions

• Hyperbaric Oxygen Therapy

Interventions

Type	Name	Description
PROCEDURE	Hyperbaric oxygen therapy	1. FiO2 0.21 - 1 ATA 2. FiO2 1 - 1 ATA 3. FiO2 1 - 2.5 ATA 4. FiO2 0.21 - 2.5 ATA 5. FiO2 0.21 - 1 ATA

Timeline

• Start date: 2019-06-14
• Primary completion: 2019-07-25
• Completion: 2019-07-25
• First posted: 2019-06-10
• Last updated: 2026-01-08

Locations

1 site across 1 country: France