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

Study Results

Results pending

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-15

Study Completion Date

2014-10-15

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).

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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.

Conditions

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Anesthesia; Functional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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3TV group

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

Group Type ACTIVE_COMPARATOR

Preoxygenation

Intervention Type PROCEDURE

8DB group

Or eight vital capacity breaths for 1 minute with FGF of 10 L/min

Group Type ACTIVE_COMPARATOR

Preoxygenation

Intervention Type PROCEDURE

Interventions

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Preoxygenation

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No