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.

Healthy Volunteers

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.

Inhaled Nitrogen

Inhaled nitric oxide selectively reverses human hypoxic pulmonary vasoconstriction without causing systemic vasodilation.

Hypoxia as a therapy for mitochondrial disease.

Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial.

Massachusetts General Hospital

Prolonged Hypoxic Breathing in Healthy Volunteers: a Safety Study

Physiological and Biochemical Response to Prolonged Exposure to Hypoxic Breathing in Healthy Volunteers

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.

Erythropoietin will be tested each day during the 7 day study period.

Pulmonary pressure will be non-invasively measured via transthoracic echocardiography each day during the 7 day study period.

Plasma reactive oxygen species (ROS) will be evaluated each day during the 7 day study period.

Venous acid-base status will be evaluated each day during the 7 day study period.

Systemic blood pressure will be regularly monitored during the 7 day study period.

Heart rate will be continuously monitored via electrocardiography (EKG) during the 7 day study period.

Respiratory rate will be regularly monitored during the 7 day study period.

Lactate levels will be tested each day during the 7 day study period.

Alpha-hydroxybutyrate levels will be tested each day during the 7 day study period.

Lorenzo Berra, MD

Assistant Professor of Anesthesia

Rezoagli, Emanuele, M.D., Massachusetts General Hospital, Harvard Medical School

Ferrari, Michele, M.D., Massachusetts General Hospital, Harvard Medical School

Patel, Sarvagna, B.A., Massachusetts General Hospital, Harvard Medical School

Zapol, Warren M., M.D., Massachusetts General Hospital, Harvard Medical School

Fisher, Daniel, R.R.T., Massachusetts General Hospital, Harvard Medical School

Jain, Isha, B.A., Massachusetts General Hospital, Harvard Medical School

Mootha, Vamsi, M.D., Massachusetts General Hospital, Harvard Medical School

Harris, Stuart N., M.D., Massachusetts General Hospital, Harvard Medical School

Karaa, Amel, M.D., Massachusetts General Hospital, Harvard Medical School

Patients will receive a 50/50 mixture of Oxygen and Nitrous oxide via non breather mask

Patients will receive a 50/50 mixture of Oxygen and Nitrous oxide via non breather mask
Inhaled Nitrous Oxide: Patients undergoing procedural sedation with Ketamine will receive inhaled Nitrous Oxide

Nitrous Oxide Arm

Sex: Female, Male

Region of Enrollment

Presence or absence of emergence reaction

Emergence Reaction

Physiologic Measure

heart rate, respiratory rate, peripheral SaO2

Vitals

verbal or physical stimulation, airway repositioning, additional oxygen, positive pressure ventilation, endotracheal intubation

Physician Interventions

Level of Sedation

Patient Recall of Procedure

Total Ketamine Dose

Total Time of Nitrous Use

Physician procedure satisfaction survey responses

Physician Procedure Satisfaction Score

Patient procedure satisfaction survey responses

Patient Procedure Satisfaction Score

Nurse procedure satisfaction survey responses

Nurse Procedure Satisfaction Score

Length of ED Stay

Overall Study

Kamran Mohiuddin. Director Clinical Research Emergency Department

Procedural Sedation

Patients undergoing procedural sedation with Ketamine will receive inhaled Nitrous Oxide

Inhaled Nitrous Oxide

Albert Einstein Healthcare Network

Inhaled Nitrous Oxide for the Prevention of Emergence Reaction During Ketamine Administration in Adults, a Pilot Study

Paul Dominici

Attending Physician

Dexmedetomidine sedated pediatric patients undergoing EEG study.

Chloral hydrate sedated pediatric patients undergoing sedated EEG study.

Dexmedetomidine 3 micrograms per kilogram per os; subsequent dose of 1 microgram per kilogram per os if necessary to treat inadequate sedation 30 minutes following initial dosing.

Dexmedetomidine

Chloral hydrate 75 milligrams per kilogram per os; subsequent dose of 25 milligrams per kilogram per os if necessary to treat inadequate sedation 30 minutes following initial dosing.

ataxia/hypoxia

Prolonged Hypoxic Breathing in Healthy Volunteers: a Safety Study

Inhaled Nitrous Oxide for the Prevention of Emergence Reaction During Ketamine Administration in Adults, a Pilot Study

Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG

Cơ sở dữ liệu đầy đủ nhất về dược liệu được hỗ trợ bởi khoa học