CO2 (Carbon Dioxide) - Cerebral Oxygenation
Primary Purpose
Hypoxia, Brain
Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Oxycarbon (5% CO2+ 95% O2)
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxia, Brain focused on measuring cerebral hypoxia, CO2, cerebral perfusion, hypoxia
Eligibility Criteria
Inclusion Criteria:
- Patients who are designated for bariatric surgery at the University Hospital Zurich (USZ)
- Informed Consent as documented by signature
- BMI >35 kg/m2
Exclusion Criteria:
- Severe end-organ damage: chronic obstuctive pulmonary disease (COPD) GOLD (cassification) III and IV, known hepatic insufficiency or elevated liver enzymes, renal creatinine clearance <30ml/min
- Severe cardiovascular disease (NYHA classification III and IV)
- Known pulmonary Hypertension
- Cerebrovascular disease
- Pregnancy and lactation
- Cardiac dysrhythmias
- acidosis, chronic pulmonary disease
- Known or suspected non-compliance, drug or alcohol abuse
Sites / Locations
- University Hospital Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oxycarbon (5% CO2 + 95% O2)
Control (95% O2)
Arm Description
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.
Same procedure as arm "active comparator"
Outcomes
Primary Outcome Measures
Time to decrease of tissue oxygenation index by 20 %
Parameter will be measured by NIRS
Secondary Outcome Measures
PaO2 (Oxygen partial pressure)
Parametere will be measured by arterial bloodgas
SpO2 (oxygen saturation)
Parametere will be measured by arterial bloodgas
PCO2 ( partial pressure of carbon)
Parametere will be measured by arterial bloodgas
Full Information
NCT ID
NCT03338907
First Posted
October 30, 2017
Last Updated
February 19, 2019
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT03338907
Brief Title
CO2 (Carbon Dioxide) - Cerebral Oxygenation
Official Title
Anesthesia vs Aviation: Does Added Carbon Dioxide in Normobaric Hypoxia Have the Same Effect on Cerebral Oxygenation as in Hypobaric Hypoxia?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
February 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Brain
Keywords
cerebral hypoxia, CO2, cerebral perfusion, hypoxia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Controlled, randomized, single blind, crossover
Masking
Participant
Masking Description
The sequence whether the IMP or the comparator is applied first will be randomly assigned using the web-based randomizer.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxycarbon (5% CO2 + 95% O2)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (95% O2)
Arm Type
Placebo Comparator
Arm Description
Same procedure as arm "active comparator"
Intervention Type
Drug
Intervention Name(s)
Oxycarbon (5% CO2+ 95% O2)
Intervention Description
Oxycarbon will be administered by mechanical ventilation
Primary Outcome Measure Information:
Title
Time to decrease of tissue oxygenation index by 20 %
Description
Parameter will be measured by NIRS
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
PaO2 (Oxygen partial pressure)
Description
Parametere will be measured by arterial bloodgas
Time Frame
1 Day
Title
SpO2 (oxygen saturation)
Description
Parametere will be measured by arterial bloodgas
Time Frame
1 Day
Title
PCO2 ( partial pressure of carbon)
Description
Parametere will be measured by arterial bloodgas
Time Frame
1Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are designated for bariatric surgery at the University Hospital Zurich (USZ)
Informed Consent as documented by signature
BMI >35 kg/m2
Exclusion Criteria:
Severe end-organ damage: chronic obstuctive pulmonary disease (COPD) GOLD (cassification) III and IV, known hepatic insufficiency or elevated liver enzymes, renal creatinine clearance <30ml/min
Severe cardiovascular disease (NYHA classification III and IV)
Known pulmonary Hypertension
Cerebrovascular disease
Pregnancy and lactation
Cardiac dysrhythmias
acidosis, chronic pulmonary disease
Known or suspected non-compliance, drug or alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Schläpfer, MD, M.Sc.
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Ist not planned to share data with other researchers
Citations:
PubMed Identifier
16695569
Citation
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.
Results Reference
background
PubMed Identifier
98161
Citation
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.
Results Reference
background
PubMed Identifier
17691228
Citation
Brzecka A. Role of hypercapnia in brain oxygenation in sleep-disordered breathing. Acta Neurobiol Exp (Wars). 2007;67(2):197-206.
Results Reference
background
PubMed Identifier
4719663
Citation
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.
Results Reference
background
PubMed Identifier
968505
Citation
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.
Results Reference
background
PubMed Identifier
15004003
Citation
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.
Results Reference
background
Learn more about this trial
CO2 (Carbon Dioxide) - Cerebral Oxygenation
We'll reach out to this number within 24 hrs