Assessment Through Transcutaneous Brain Oximetry (NIRS) of Two Preoxygenation Techniques

Study Overview
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Brief Summary
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Preoxygenation techniques is currently considered a standard of care, but how they influence cerebral oxygenation remains largely unknown. In this study, the investigators compare three minutes tidal volume breathing versus eight vital capacity, deep breaths (8DB) technique. Forty-eight patients scheduled for surgery under general anesthesia were included in a randomized study design. The main endpoints were arterial partial pressure of O2 (PaO2) and regional cerebral oxygen saturation (rScO2 ; INVOS TM -5100- C) which were measured at baseline (T1), end of pre-oxygenation (T2) and after desaturation during apnoea to 95% (T3).

Detailed Description
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Hypoxemia secondary to the inability to secure the airway remains the main cause of anesthesia-related morbidity and mortality. Preoxygenation with 100% oxygen before induction of anesthesia is currently considered a standard of care and practiced routinely for all patients, and especially carefully for high-risk cases. It is an essential component of the rapid sequence induction technique. Common pre-oxygenation techniques include the 3 min tidal volume breathing (3TV) and the eight vital capacity, deep breaths (8DB). Their efficiency has been extensively assessed by measuring the rate of decline of SaO2 during apnea after induction/paralysis, with 'time to desaturation (to 95% or 90%) being the endpoint of many studies. This is arguably a surrogate endpoint for oxygen stores and Pandit et al. estimated the total amount of oxygen taken up by the body in these techniques using breath-by-breath gas analysis. An even more relevant measure is the impact of preoxygenation on tissue stores of oxygen, but this is difficult to quantify. Especially, given its vulnerability to hypoxemia due to its high energy requirements compared to the low energy reserves, the brain is particularly susceptible. Cerebral oximetry is a noninvasive monitoring technique that uses near-infrared spectroscopy (NIRS) to measure regional cerebral oxygen saturation (rScO2). Continuous rScO2 monitoring has shown to be useful in detecting mismatch of oxygen supply and demand in the brain and assessing cerebral autoregulation in real-time. This offers a means to measure tissue oxygenation in a relevant organ with pre-oxygenation. The primary aim of the present study was to test the hypothesis that different pre-oxygenation techniques result in different degrees of cerebral oxygenation as measured by rScO2 with the INVOSTM-5100-C. The investigators wished to compare the 3TV method with the 8DB method, as being the two methods that produced the highest increases in body oxygen stores in previous experiments; the null hypothesis that these would yield similar degrees of brain oxygenation. The investigators also wished to assess whether, regardless of the preoxygenation technique, there were differences between arterial PO2 and rScO2 dynamics with preoxygenation and subsequent apnoea.

Official Title
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Comparing the Dynamics of Changes in Regional Cerebral Oxygen Saturation With Arterial Oxygen Partial Pressure With Two Techniques of Preoxygenation in Healthy Adults

Conditions
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Anesthesia; Functional

Intervention / Treatment
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* Procedure: Preoxygenation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult patients scheduled for surgery under general anaesthesia with tracheal intubation ASA physical status 1 aged between 18 and 65 years. Exclusion Criteria: Baseline peripheral oxygen saturation (SpO2) of less than 95%, BMI > 30 kg.m-2, cardiac, respiratory or brain diseases, previous or active smoking, predicted difficult airway, frontal sinusitis, cerebral vascular disorders, hemoglobin less than 13g.dL-1, low-quality rScO2 signal.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3TV group<br>Patients were randomly assigned to receive either three minutes tidal volume (3TV) with a fresh gas flow (FGF 100% O2) via facemask of 5 L/min | Procedure: Preoxygenation<br> <br> |
| Active Comparator: 8DB group<br>Or eight vital capacity breaths for 1 minute with FGF of 10 L/min | Procedure: Preoxygenation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral regional oxygen saturation (rScO2) | rScO2 using an INVOSTM 5100C monitor (Somanetics Corporation, Michigan, USA) and Adult SomaSensor® SAFB-SM sensors (Covidien LLC, MA, USA) placed according to the manufacturers' instructions. | Preoxygenation period, an average of 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pO2 | partial pressure of oxygen through samples for arterial blood gas analyses using the GEM® Premier 3000 monitor (Instrumentation Laboratory. Lexington, MA, USA). | Preoxygenation period, an average of 10 minutes | 
| pCO2 | partial pressure of CO2 through samples for arterial blood gas analyses using the GEM® Premier 3000 monitor (Instrumentation Laboratory. Lexington, MA, USA). | Preoxygenation period, an average of 10 minutes | 
| bispectral index (BIS) | by means of a BIS VISTATM monitor (Aspect Medical Systems Inc, Massachusetts, USA) | Preoxygenation period, an average of 10 minutes | 
| Cardiac index (CI) | using a VigileoTM monitor (Edwards Lifesciences LLC. Irvine, USA | Preoxygenation period, an average of 10 minutes | 
| continuous intra-arterial blood pressure | . A 20-G cannula was placed in the left radial artery to obtain continuous intra-arterial blood pressure | Preoxygenation period, an average of 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway management, general anaesthesia, standard of care, respiration, neurophysiological monitoring.