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OpenTrials
Completed

NCT Number: NCT03338907

CO2 (Carbon Dioxide) - Cerebral Oxygenation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Zurich

Zurich, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycarbon (5% CO2+ 95% O2)

Drug

Oxycarbon will be administered by mechanical ventilation

Primary outcomes

  1. Time to decrease of tissue oxygenation index by 20 %

    Time frame: 1 Day

    Parameter will be measured by NIRS

Secondary outcomes

  1. PaO2 (Oxygen partial pressure)

    Time frame: 1 Day

    Parametere will be measured by arterial bloodgas

  2. SpO2 (oxygen saturation)

    Time frame: 1 Day

    Parametere will be measured by arterial bloodgas

  3. PCO2 ( partial pressure of carbon)

    Time frame: 1Day

    Parametere will be measured by arterial bloodgas

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Anesthesia vs Aviation: Does Added Carbon Dioxide in Normobaric Hypoxia Have the Same Effect on Cerebral Oxygenation as in Hypobaric Hypoxia?

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Nov 9, 2017
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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