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Several projects in high altitude research in environments with a low oxygen partial pressure (hypobaric hypoxia) leading to hypoxemia showed, that cerebral perfusion and cerebral performance could be improved by adding C02 (cabon dioxide).
The investigators hypothesize that adding 5% C02 to 02 (Oxygen) also under normobaric conditions increases the time until a significant cerebral hyopxia is measured by near infrared spectroscopy (NIRS) compared to the administration of 95% 02.
lf this hypothesis proves to be true, this approach might be used in situations in which individuals are prone to cerebral hypoxia. In bariatric surgery, patients that experience an apnea phase are more prone to (cerebral) hypoxia due to the fact, that they have a higher body mass index (BMI) leading to a reduced functional residual capacity (FRC), which serves as the oxygen reserve in the body.
On the day of surgery patients will be randomized. After induction of anesthesia and endotracheal intubation patients will be managed by the study team to perform the intervention and the measurements.
According to randomization, investigational medical product (IMP) or comparator will be administrated by ventilator 1/ventilator 2.
At time point 1 apnea will be performed by disconnecting the ventilator from the endotracheal tube until the NIRS value has dropped by 20% from baseline. After that, re-ventilation will be resumed immediately, until parameters have returned to baseline.
During apnea time NIRS and vital signs will be recorded permanently, blood samples will be drawn at definite time points.
Application of IMP (or comparator) will be performed in this cross-over study design in the same manner after the baseline level is reached again.
At the end of the study procedure, after the baseline level of end-expiratory CO2 is reached again, patient will be taken over by the clinical anesthesia team and surgeons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycarbon (5% CO2 + 95% O2) | Experimental | Patients will be mechanical ventilated with Oxycarbon (5%CO2 +95% O2) after normocapnia is reached until FeO2 is stable for at least 1 min ≥ 80%. At timepoint 1 immediately prior apnea NIRS and vital parameters will be registered and an bloodsample will be drawn. |
|
| Control (95% O2) | Placebo Comparator | Same procedure as arm "active comparator" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycarbon (5% CO2+ 95% O2) | Drug | Oxycarbon will be administered by mechanical ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to decrease of tissue oxygenation index by 20 % | Parameter will be measured by NIRS | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| PaO2 (Oxygen partial pressure) | Parametere will be measured by arterial bloodgas | 1 Day |
| SpO2 (oxygen saturation) | Parametere will be measured by arterial bloodgas |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Schläpfer, MD, M.Sc. | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Zurich | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16695569 | Background | Kety SS, Schmidt CF. THE EFFECTS OF ALTERED ARTERIAL TENSIONS OF CARBON DIOXIDE AND OXYGEN ON CEREBRAL BLOOD FLOW AND CEREBRAL OXYGEN CONSUMPTION OF NORMAL YOUNG MEN. J Clin Invest. 1948 Jul;27(4):484-92. doi: 10.1172/JCI101995. No abstract available. | |
| 98161 | Background | Karl AA, McMillan GR, Ward SL, Kissen AT, Souder ME. Effects of increased ambient CO2 on brain tissue oxygenation and performance in the hypoxic rhesus. Aviat Space Environ Med. 1978 Aug;49(8):984-9. |
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Ist not planned to share data with other researchers
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| ID | Term |
|---|---|
| D002534 | Hypoxia, Brain |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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Controlled, randomized, single blind, crossover
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The sequence whether the IMP or the comparator is applied first will be randomly assigned using the web-based randomizer.
| 1 Day |
| PCO2 ( partial pressure of carbon) | Parametere will be measured by arterial bloodgas | 1Day |
| 17691228 | Background | Brzecka A. Role of hypercapnia in brain oxygenation in sleep-disordered breathing. Acta Neurobiol Exp (Wars). 2007;67(2):197-206. doi: 10.55782/ane-2007-1648. |
| 4719663 | Background | Kronenberg RS, Drage CW. Attenuation of the ventilatory and heart rate responses to hypoxia and hypercapnia with aging in normal men. J Clin Invest. 1973 Aug;52(8):1812-9. doi: 10.1172/JCI107363. |
| 968505 | Background | Hannay DR, Maddox EJ. Symptom prevalence and referral behaviour in Glasgow. Soc Sci Med (1967). 1976 Mar-Apr;10(3-4):185-9. doi: 10.1016/0037-7856(76)90046-9. No abstract available. |
| 15004003 | Background | Ainslie PN, Poulin MJ. Ventilatory, cerebrovascular, and cardiovascular interactions in acute hypoxia: regulation by carbon dioxide. J Appl Physiol (1985). 2004 Jul;97(1):149-59. doi: 10.1152/japplphysiol.01385.2003. Epub 2004 Mar 5. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |