Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The frequency of preoperative cardiac ischemia and the 30-days postoperative mortality is much higher than previously assumed, with approximately 10 % of patients undergoing non-cardiac surgery suffering from postoperative myocardial injury. A recent danish study furthermore showed that patients treated with a high inspiratory oxygen fraction during surgery had a higher 1 year mortality compared with patients treated with a low inspiratory fraction. This was especially significant among patients undergoing cancer surgery. A possible explanation, is that a high oxygen fraction results in oxidative stress and endothelial dysfunction.
With this randomized cross-over study we wish to investigate the effect of a high inspiratory oxygen fraction on the endothelial function among healthy male volunteers. The primary outcome is the endothelial function assessed by the EndoPat system. Secondary outcomes are changes in oxidative biomarkers. Heart rate variability (HRV) recordings will serve as a measure for the effect of oxygen on the autonomic nervous system.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30% oxygen | Placebo Comparator | Inhalation of 30% oxygen |
|
| 80% oxygen | Experimental | Inhalation of 80% oxygen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 80% oxygen | Other |
| ||
| 30% oxygen |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial dysfunction assessed by the EndoPat-system | Changes in baseline pulse-wave-amplitude (PWA) after ischemia-reperfusion from the baseline PWA measurement until 5 minutes after ischemia as a measure of altered endothelial cell function caused by high inspiratory oxygen fractions | After 2 hours of preoxygenation |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability (HRV) after ischemia-reperfusion as a measure of altered balance in the Autonomic nervous system | Baseline measure conducted from baseline until 20 minutes of pre oxygenation. Secondary measures is conducted 20 minutes before withdrawal of the oxygen | |
| Plasma-Malondialdehyde (MDA) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ismail Gögenur, MD, DMSc | Department of surgery, Køge University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHKoge | Køge | 4600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28922226 | Derived | Larsen MHH, Ekeloef S, Kokotovic D, Schou-Pedersen AM, Lykkesfeldt J, Gogenur I. Effect of High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers: A Randomized Controlled Crossover Pilot Study. Anesth Analg. 2017 Nov;125(5):1793-1796. doi: 10.1213/ANE.0000000000002357. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure |
| Plasma-Arginine/Asymmetric dimethylarginine(ADMA) | Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure |
| Plasma-Tetrahydrobiopterin | Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure |
| Plasma-Advanced oxidation protein products (AOPP) | Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure |
| Plasma-Ascorbate/Dehydroascorbate (AA/DHA) | Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure |