CO2 (Carbon Dioxide) - Cerebral Oxygenation

NCT03338907 | Completed Phase 2

• 1 other identifier: 2017-01790
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia, Brain

Keywords

cerebral hypoxia; CO2; cerebral perfusion; hypoxia

Outcome Measures

Primary Outcomes (1)

• Time to decrease of tissue oxygenation index by 20 %

  Parameter will be measured by NIRS

  1 Day

Secondary Outcomes (3)

• PaO2 (Oxygen partial pressure)

  1 Day

• SpO2 (oxygen saturation)

  1 Day

• PCO2 ( partial pressure of carbon)

  1Day

Study Arms (2)

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.

Drug: Oxycarbon (5% CO2+ 95% O2)

Control (95% O2)

PLACEBO COMPARATOR

Same procedure as arm "active comparator"

Drug: Oxycarbon (5% CO2+ 95% O2)

Interventions

Oxycarbon (5% CO2+ 95% O2) DRUG

Oxycarbon will be administered by mechanical ventilation

Control (95% O2); Oxycarbon (5% CO2 + 95% O2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are designated for bariatric surgery at the University Hospital Zurich (USZ)
• Informed Consent as documented by signature
• BMI \>35 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 16695569 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.

  PMID: 98161 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.

  PMID: 17691228 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.

  PMID: 4719663 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.

  PMID: 968505 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.

  PMID: 15004003 BACKGROUND

MeSH Terms

Conditions

Hypoxia, Brain; Hypoxia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Schläpfer, MD, M.Sc.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The sequence whether the IMP or the comparator is applied first will be randomly assigned using the web-based randomizer.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled, randomized, single blind, crossover

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 9, 2017
• Study Start: January 25, 2018
• Primary Completion: October 26, 2018
• Study Completion: February 12, 2019
• Last Updated: February 20, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)