Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04352049
Enrollment
53
Registered
2020-04-17
Start date
2012-04-15
Completion date
2014-10-15
Last updated
2020-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia; Functional

Keywords

airway management, general anaesthesia, standard of care, respiration, neurophysiological monitoring.

Brief summary

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

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.

Interventions

PROCEDUREPreoxygenation

Sponsors

Complexo Hospitalario Universitario de A Coruña
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cerebral regional oxygen saturation (rScO2)Preoxygenation period, an average of 10 minutesrScO2 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.

Secondary

MeasureTime frameDescription
pO2Preoxygenation period, an average of 10 minutespartial pressure of oxygen through samples for arterial blood gas analyses using the GEM® Premier 3000 monitor (Instrumentation Laboratory. Lexington, MA, USA).
pCO2Preoxygenation period, an average of 10 minutespartial pressure of CO2 through samples for arterial blood gas analyses using the GEM® Premier 3000 monitor (Instrumentation Laboratory. Lexington, MA, USA).
bispectral index (BIS)Preoxygenation period, an average of 10 minutesby means of a BIS VISTATM monitor (Aspect Medical Systems Inc, Massachusetts, USA)
Cardiac index (CI)Preoxygenation period, an average of 10 minutesusing a VigileoTM monitor (Edwards Lifesciences LLC. Irvine, USA
continuous intra-arterial blood pressurePreoxygenation period, an average of 10 minutes. A 20-G cannula was placed in the left radial artery to obtain continuous intra-arterial blood pressure

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026