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

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).

Study Overview

• Status: Completed
• Conditions: Anesthesia; Functional
• Intervention / Treatment: Procedure: Preoxygenation

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15004
    • Complexo Hospitalario Universitario de A Coruña
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Manuel Gómez-Ríos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: Preoxygenation
Active Comparator: 8DB group; Or eight vital capacity breaths for 1 minute with FGF of 10 L/min	Procedure: Preoxygenation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Complexo Hospitalario Universitario de A Coruña
• Investigators: Study Director: Jose C Garzón, MD, Complejo Asistencial Salamanca

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2012
• Primary Completion (Actual): October 15, 2014
• Study Completion (Actual): October 15, 2014

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: general anaesthesia; airway management; respiration; standard of care; neurophysiological monitoring.
• Other Study ID Numbers: JCG-PTO-2012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No