Clinical trial NCT04352049: Assessment Through Transcutaneous Brain Oximetry (NIRS) of Two Preoxygenation Techniques
Official title: Comparing the Dynamics of Changes in Regional Cerebral Oxygen Saturation With Arterial Oxygen Partial Pressure With Two Techniques of Preoxygenation in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia; Functional
Keywords: airway management
general anaesthesia
standard of care
respiration
neurophysiological monitoring.
Lead sponsor: Complexo Hospitalario Universitario de A Coruña
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cerebral regional oxygen saturation (rScO2)
timeFrame: Preoxygenation period, an average of 10 minutes
Secondary outcomes:
measure: pO2
timeFrame: Preoxygenation period, an average of 10 minutes
measure: pCO2
timeFrame: Preoxygenation period, an average of 10 minutes
measure: bispectral index (BIS)
timeFrame: Preoxygenation period, an average of 10 minutes
measure: Cardiac index (CI)
timeFrame: Preoxygenation period, an average of 10 minutes
measure: continuous intra-arterial blood pressure
timeFrame: Preoxygenation period, an average of 10 minutes
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Manuel Gómez-Ríos
state: Galicia
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario de A Coruña
Study officials:
affiliation: Complejo Asistencial Salamanca
name: Jose C Garzón, MD
role: STUDY_DIRECTOR
References:
citation: Joffe AM, Aziz MF, Posner KL, Duggan LV, Mincer SL, Domino KB. Management of Difficult Tracheal Intubation: A Closed Claims Analysis. Anesthesiology. 2019 Oct;131(4):818-829. doi: 10.1097/ALN.0000000000002815.
citation: Baillard C, Boubaya M, Statescu E, Collet M, Solis A, Guezennec J, Levy V, Langeron O. Incidence and risk factors of hypoxaemia after preoxygenation at induction of anaesthesia. Br J Anaesth. 2019 Mar;122(3):388-394. doi: 10.1016/j.bja.2018.11.022. Epub 2018 Dec 29.
citation: Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.
citation: Pandit JJ. The analysis of variance in anaesthetic research: statistics, biography and history. Anaesthesia. 2010 Dec;65(12):1212-20. doi: 10.1111/j.1365-2044.2010.06542.x.