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NCT Number: NCT04352049

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manuel Gómez-Ríos, A Coruña, Galicia, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Preoxygenation

Procedure

Primary outcomes

  1. Cerebral regional oxygen saturation (rScO2)

    Time frame: Preoxygenation period, an average of 10 minutes

    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.

Secondary outcomes

  1. pO2

    Time frame: Preoxygenation period, an average of 10 minutes

    partial pressure of oxygen through samples for arterial blood gas analyses using the GEM® Premier 3000 monitor (Instrumentation Laboratory. Lexington, MA, USA).

  2. pCO2

    Time frame: Preoxygenation period, an average of 10 minutes

    partial pressure of CO2 through samples for arterial blood gas analyses using the GEM® Premier 3000 monitor (Instrumentation Laboratory. Lexington, MA, USA).

  3. bispectral index (BIS)

    Time frame: Preoxygenation period, an average of 10 minutes

    by means of a BIS VISTATM monitor (Aspect Medical Systems Inc, Massachusetts, USA)

  4. Cardiac index (CI)

    Time frame: Preoxygenation period, an average of 10 minutes

    using a VigileoTM monitor (Edwards Lifesciences LLC. Irvine, USA

  5. continuous intra-arterial blood pressure

    Time frame: Preoxygenation period, an average of 10 minutes

    . A 20-G cannula was placed in the left radial artery to obtain continuous intra-arterial blood pressure

Sponsors and collaborators

Lead sponsor

Complexo Hospitalario Universitario de A Coruña

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 17, 2020
Registry last updated
Apr 17, 2020

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

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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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