CO2 (Carbon Dioxide) - Cerebral Oxygenation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-25

Study Completion Date

2019-02-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypoxia, Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Controlled, randomized, single blind, crossover

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The sequence whether the IMP or the comparator is applied first will be randomly assigned using the web-based randomizer.

Study Groups

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Oxycarbon (5% CO2 + 95% O2)

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.

Group Type EXPERIMENTAL

Oxycarbon (5% CO2+ 95% O2)

Intervention Type DRUG

Oxycarbon will be administered by mechanical ventilation

Control (95% O2)

Same procedure as arm "active comparator"

Group Type PLACEBO_COMPARATOR

Oxycarbon (5% CO2+ 95% O2)

Intervention Type DRUG

Oxycarbon will be administered by mechanical ventilation

Interventions

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Oxycarbon (5% CO2+ 95% O2)

Oxycarbon will be administered by mechanical ventilation

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No