Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03980210
Study type Interventional
Source University Hospital, Lille
Contact
Status Completed
Phase N/A
Start date June 14, 2019
Completion date July 25, 2019

See also
  Status Clinical Trial Phase
Suspended NCT01365780 - Hyperbaric Oxygen Therapy in Distal Radius Fractures: Can it Shorten Recovery Time and Increase Fracture Healing? N/A
Completed NCT05136716 - Effect of Hyperbaric Oxygen Therapy on Cerebral Palsy N/A
Recruiting NCT05289700 - Hyperbaric-oxygen Therapy (HBOT) Versus Placebo for Treating Vaso-Occlusive Crisis (VOC) in Sickle Cell Disease (SCD) Phase 3
Recruiting NCT05031949 - Hyperbaric Oxygen Therapy Combined Camrelizumab in Patients With Advanced/Metastatic Hepatocellular Carcinoma Phase 1
Recruiting NCT03144206 - Hyperbaric Oxygen Therapy for Soft Tissue Sarcoma Pilot Study Phase 4
Recruiting NCT05078073 - HBOT in the Treatment and Prevention of aGVHD N/A
Completed NCT04358796 - Measuring Cognitive Enhancement During Hyperbaric Oxygen Treatments N/A
Terminated NCT03339037 - Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children N/A
Enrolling by invitation NCT02452619 - MRI Brain Changes Induced by Hyperbaric Oxygen Therapy in Brain Injury Patients N/A
Recruiting NCT04311437 - Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy N/A
Not yet recruiting NCT04376359 - The Effectiveness of Hyperbaric Oxygen Therapy on Pneumonia Complicating Stroke N/A
Completed NCT02619383 - HBOT Application in Erectile Dysfunction Phase 1
Not yet recruiting NCT03526796 - Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis N/A
Completed NCT03615755 - Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine N/A
Not yet recruiting NCT05980195 - Cognitive Improvement After Carotid Stenting in Hyperbaric Oxygen Therapy Trial N/A