Anesthesia Clinical Trial
— MAASOfficial title:
Accuracy of the MAAS Method (Minimal-flow Auto-control Anesthesia System) for the Administration of Desflurane and Sevoflurane in the Anesthetic Maintenance Phase. Prospective and Paired Observational Study.
In the present work the investigators will study the accuracy of the MAAS (Minimal-flow Autocontrol Anesthesia System) method to estimate the percentage of halogenated anesthetic (HA) to be supplied to the anesthetic circuit based on the estimation of HA uptake during the maintenance phase. The investigators will evaluate the accuracy of sevoflurane and desflurane vaporizers to guarantee the administration of that amount of estimated HA, thus guaranteeing the maintenance of the target concentration of HA at the end of expiration: end-tidal target HA% (ettHA%). To do this, the investigators will quantify the number of adjustments that need to be made to each vaporizer to maintain ettHA%. As secondary objectives, the investigators will analyze the time to reach the target concentration of HA, the deviations that occur from that concentration despite the correct application of the method, and the consumption of HA during the procedure. Through the entire procedure, all participants will be ventilated under a tailored open lung approach (tOLA) strategy.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | September 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Adult subjects (= 18 years) scheduled for robotic urological, coloproctological or gynecological surgery in the investigators´ institution - Written informed consent Exclusion Criteria: - Participation in another interventional study - Participants unable to understand the information contained in the informed consent - American Society of Anesthesiologists (ASA) classification grade = IV - Patient in dialysis - Chronic obstructive pulmonary disease (COPD) grade Global Initiative for Chronic Obstructive Lung Disease(GOLD) > 2 - Functional vital capacity < 60% or > 120% of the predicted - Body mass index (BMI) > 35 kg/m2 - New York Heart Association (NYHA) functional class = 3 - Clinically suspected heart failure - Diagnosis or suspicion of intracranial hypertension - Presence of pneumothorax or giant bullae on preoperative imaging tests - Use of Continuous Positive Airway Pressure (CPAP). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
Brattwall M, Warren-Stomberg M, Hesselvik F, Jakobsson J. Brief review: theory and practice of minimal fresh gas flow anesthesia. Can J Anaesth. 2012 Aug;59(8):785-97. doi: 10.1007/s12630-012-9736-2. Epub 2012 Jun 1. — View Citation
Carter LA, Oyewole M, Bates E, Sherratt K. Promoting low-flow anaesthesia and volatile anaesthetic agent choice. BMJ Open Qual. 2019 Sep 13;8(3):e000479. doi: 10.1136/bmjoq-2018-000479. eCollection 2019. — View Citation
Colak YZ, Toprak HI. Feasibility, safety, and economic consequences of using low flow anesthesia according to body weight. J Anesth. 2020 Aug;34(4):537-542. doi: 10.1007/s00540-020-02782-y. Epub 2020 May 3. — View Citation
Ferrando C, Suarez-Sipmann F, Tusman G, Leon I, Romero E, Gracia E, Mugarra A, Arocas B, Pozo N, Soro M, Belda FJ. Open lung approach versus standard protective strategies: Effects on driving pressure and ventilatory efficiency during anesthesia - A pilot, randomized controlled trial. PLoS One. 2017 May 11;12(5):e0177399. doi: 10.1371/journal.pone.0177399. eCollection 2017. — View Citation
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Sherman J, Le C, Lamers V, Eckelman M. Life cycle greenhouse gas emissions of anesthetic drugs. Anesth Analg. 2012 May;114(5):1086-90. doi: 10.1213/ANE.0b013e31824f6940. Epub 2012 Apr 4. — View Citation
Tusman G, Groisman I, Fiolo FE, Scandurra A, Arca JM, Krumrick G, Bohm SH, Sipmann FS. Noninvasive monitoring of lung recruitment maneuvers in morbidly obese patients: the role of pulse oximetry and volumetric capnography. Anesth Analg. 2014 Jan;118(1):137-44. doi: 10.1213/01.ane.0000438350.29240.08. — View Citation
Wetz AJ, Mueller MM, Walliser K, Foest C, Wand S, Brandes IF, Waeschle RM, Bauer M. End-tidal control vs. manually controlled minimal-flow anesthesia: a prospective comparative trial. Acta Anaesthesiol Scand. 2017 Nov;61(10):1262-1269. doi: 10.1111/aas.12961. Epub 2017 Aug 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes made in the sevoflurane vaporizer | Number of adjustments that must be made in the sevoflurane vaporizer to maintain the predefined end-tidal target of sevoflurane (ettSEVO%). | 60 minutes, starting from the end of Phase sevo 1 (once filled the HPO compartment) | |
Primary | Changes made in the desflurane vaporizer | Number of adjustments that must be made in the desflurane vaporizer to maintain the predefined end-tidal target of desflurane (ettDESFLU%). | 60 minutes, starting from the end of Phase desflu 1(once filled the HPO compartment) | |
Secondary | Time to reach the ettSEVO% | Time (minutes) to reach the ettSEVO%; measured from the time of OTI until completing the Phase sevo 1. Includes M1 and M2 of this Phase. | Immediately after OTI and until completing the Phase sevo 1 | |
Secondary | Time to reach the ettDESFLU% | Time (minutes) to reach the ettDESFLU%; measured from the starting of Phase desflu 1 until completing this Phase desflu 1. Includes M1 and M2 of this Phase. | Immediately after completing the Washout phase and until completing the Phase desflu 1. | |
Secondary | Deviations from ettSEVO% despite the correct application of the method | Deviations that occur from that ettSEVO% despite the correct application of the method.
Following the modified Wetz model, all the time periods in which the HA is outside the target range will be recorded, as well as the percentage of deviation over that range. Then, the investigators will calculate the duration of those periods with deviated values with respect to the total duration of the measured phase. The accuracy and stability of the method will be established based on the duration of these periods and their magnitude (degree of deviation) with respect to the study phase. |
60 minutes: starting from the end of Phase sevo 1 until the end of Phase sevo 2 | |
Secondary | Deviations from ettDESFLU% despite the correct application of the method | Following the modified Wetz model, all the time periods in which the HA is outside the target range will be recorded, as well as the percentage of deviation over that range. Then, we will calculate the duration of those periods with deviated values with respect to the total duration of the measured phase. The accuracy and stability of the method will be established based on the duration of these periods and their magnitude (degree of deviation) with respect to the study phase. | 60 minutes: starting from the end of Phase desflu1 until the end of Phase desflu 2 | |
Secondary | Consumption of HA (ml of HA in its liquid phase) during the procedure | To estimate the consumption of ml of liquid HA, the investigators will calculate the difference in weight of the vaporizer before and after procedure in each case, using a precision scale and taking into account the density and specific weight specifications set by the manufacturer for sevoflurane and desflurane. | During the procedure: starting pre-intervention and immediately after the procedure |
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