Anesthesia; Functional Clinical Trial
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
Verified date | April 2020 |
Source | Complexo Hospitalario Universitario de A Coruña |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 53 |
Est. completion date | October 15, 2014 |
Est. primary completion date | October 15, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Complexo Hospitalario Universitario de A Coruña | A Coruña | |
Spain | Manuel Gómez-Ríos | A Coruña | Galicia |
Lead Sponsor | Collaborator |
---|---|
Complexo Hospitalario Universitario de A Coruña |
Spain,
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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | bispectral index (BIS) | by means of a BIS VISTATM monitor (Aspect Medical Systems Inc, Massachusetts, USA) | Preoxygenation period, an average of 10 minutes | |
Secondary | Cardiac index (CI) | using a VigileoTM monitor (Edwards Lifesciences LLC. Irvine, USA | Preoxygenation period, an average of 10 minutes | |
Secondary | 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 |
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