Prolonged Hypoxic Breathing in Healthy Volunteers: a Safety Study (MGH-nitrogen)
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|ClinicalTrials.gov Identifier: NCT02860975|
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : March 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Other: Inhaled Nitrogen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Physiological and Biochemical Response to Prolonged Exposure to Hypoxic Breathing in Healthy Volunteers|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Inhaled Nitrogen
A humidified mixture of gas will be delivered by mask, nasal cannulae, and small room-sized tent. Inspiratory oxygen fraction (FiO2) will be gradually decreased to 11% over a period or five days to obtain a peripheral capillary O2 saturation (SpO2) between 80%-85% (corresponding to 40-55 mmHg of arterial partial oxygen pressure (PaO2)). Healthy volunteers will be monitored and blood and urine will be obtained at 24h and 48 hours after returning to normoxia.
Other: Inhaled Nitrogen
To create the correct gas mixture, nitrogen tanks or membrane technology nitrogen generators will be utilized.
Humidified, high flow, hypoxic gas by nasal cannula will allow the participant to walk short distances, eat, execute basic personal needs (e.g., use of toilette, washing, bathing etc.), or take breaks from wearing the mask.
- Peripheral oxygen saturation [ Time Frame: 7 days ]Peripheral oxygen saturation of the healthy volunteers receiving different levels of FiO2 will be continuously monitored for the 5 days of hypoxia titration and the 2 days after return to normoxia.
- Erythropoiesis [ Time Frame: 7 days ]Erythropoietin will be tested each day during the 7 day study period.
- Pulmonary pressure [ Time Frame: 7 days ]Pulmonary pressure will be non-invasively measured via transthoracic echocardiography each day during the 7 day study period.
- Mitochondrial oxidative stress [ Time Frame: 7 days ]Plasma reactive oxygen species (ROS) will be evaluated each day during the 7 day study period.
- Acid-base status [ Time Frame: 7 days ]Venous acid-base status will be evaluated each day during the 7 day study period.
- Systemic blood pressure [ Time Frame: 7 days ]Systemic blood pressure will be regularly monitored during the 7 day study period.
- Heart rate [ Time Frame: 7 days ]Heart rate will be continuously monitored via electrocardiography (EKG) during the 7 day study period.
- Respiratory rate [ Time Frame: 7 days ]Respiratory rate will be regularly monitored during the 7 day study period.
- Anaerobiotic glycolytic pathway [ Time Frame: 7 days ]Lactate levels will be tested each day during the 7 day study period.
- Energy metabolism [ Time Frame: 7 days ]Alpha-hydroxybutyrate levels will be tested each day during the 7 day study period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860975
|Contact: Lorenzo Berra, MDfirstname.lastname@example.org|
|Contact: Warren Myron Zapol, MD||617-643-4349||WZAPOL@mgh.harvard.edu|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02134|
|Contact: Lorenzo Berra, MD 617-643-7733 email@example.com|
|Principal Investigator:||Lorenzo Berra, MD||Massachusetts General Hospital|