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Oxygen ConsumptionNCT05511584

Oxygen Consumption and Sevoflurane Uptake Based on Physiological Dead Space Estimation

A study testing VO2 estimation and SEVOup estimation in people with Oxygen Consumption and Sevoflurane, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this study, the investigators will evaluate whether the delivered fraction of oxygen (O2) and sevoflurane administered through a a closed circuit and calculated on the basis of the estimations of O2 consumption (VO2) and sevoflurane uptake (SEVOup) through the inspired-expired fraction gradients of both gases once… Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
VO2 estimation and SEVOup estimation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteSpain
Study dates
1 Feb 2023to 31 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult subjects (≥ 18 years) scheduled for robotic prostatic surgery at the investigators´ institution
  • Written informed consent

Who cannot join

  • 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
Show all 14Show fewer
  • Body mass index (BMI) > 35 kg/m2
  • Relation arterial pressure of oxygen (PaO2)/FiO2 <200 mmHg in the baseline sample
  • Presence of mechanical ventilation in the 72 hours prior to enrollment
  • 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).

Trial locations and contacts

1 site in 1 country.

Manuel de la Matta, MD contact

0034 647 49 33 62

mdlmatta@hotmail.com

Manuel de la Matta, MD contact

Spain1 site, 1 recruiting
  • Hospital Universitario Virgen del Rocío

    Seville, 41013

    Manuel de la Matta, MD, 00 34 647 49 33 62, mdlmatta@hotmail.com

    Daniel López-Herrera, PhD

    Recruiting

Other trials in Spain

About this study

Official title: Oxygen Consumption and Sevoflurane Uptake Based on Physiological Dead Space Estimation During Closed Circuit Anesthesia: A Prospective Interventional Study

In this study, the investigators will evaluate whether the delivered fraction of oxygen (O2) and sevoflurane administered through a a closed circuit and calculated on the basis of the estimations of O2 consumption (VO2) and sevoflurane uptake (SEVOup) through the inspired-expired fraction gradients of both gases once subtracted the physiological dead space (VDphys), adequately fits the real gases consumption. All participants will be ventilated under a tailored open lung approach (tOLA) strategy.

Read the detailed description

The "quantity" of the lung that participates in gas exchange in anesthetized and mechanically ventilated patients varies depending on individual conditions. This "part" of the lung that is responsible for "breathing" is referred as the respiratory volume in contrast to that "part" or volume of the lung that is in charge of driving the air towards the respiratory zones: the trachea, bronchi, et cetera, which do not directly participate in breathing. This conduction volume, together with that alveolar volume excluded from gas exchange due to different circumstances, constitutes the physiological dead space (VDphys), which represents the percentage of tidal volume that does not participate of respiration. The VDphys can be estimated by different means.

Knowing the VDphys will allow the clinicians to more precisely adjust the amount of oxygen and anesthetic gas (sevoflurane) to be supplied to the anesthesia workstation when working in a closed circuit mode, given that the estimations of VO2 and SEVOup, and consequently of the milliliters of oxygen and sevoflurane to supply per minute (DO2 and SEVOsuppl, respectively), are calculated in the basis of the "respiratory" volume rather that in the "total" tidal volume (TV); this is, taking in consideration the VDphys/TV ratio.

In this work, the investigators will evaluate the accuracy in estimating VO2 and SEVOup taking into consideration the VDphys/TV ratio when working with a closed circuit mode of anesthesia administration. The investigators will study the relationship between the DO2 and SEVOsuppl, calculated based on VDphys/TV ratio, and the real consumption of O2 and sevoflurane measured through the gas analyzer of the anesthesia workstation.

Methods

This one-arm interventional study corresponds to phase 3 of the study "Influence of Inspiratory Pause on Ventilatory Efficiency in Robotic Surgery. A Prospective Paired Study". Participants will be consecutively recruited among those patients submitted to prostatic robotic surgery, once obtained the corresponding informed consent. The study will be carried out in a tertiary care teaching hospital (Hospital Universitario Virgen del Rocío). Approval for this study will be sought from the local ethics committee. The recruitment will be made on investigators availability.

Study protocol Participants will be ventilated through a Primus anesthesia workstation (Drager, Telford, PA, USA) using a TV of 7 mL/kg of predicted body weight. The ventilation mode used will be volume control, which will include an inspiration: expiration ratio of 1:2 and a respiratory rate of 12-15 breaths/min to maintain carbon dioxide (CO2) at the end of expiration (etCO2) between 35 and 40 mmHg and an initial positive end expiratory pressure (PEEP) of 5 cmH2O. A 30 % end inspiratory pause will be scheduled for all participants. A fresh gas flow of 0.5 to 1 L/min with an inspired fraction of oxygen (FIO2) of 0.5 will be used throughout the procedure. Anesthesia will be maintained with remifentanil 0.03 to 0.05 µg/kg/min and sevoflurane, with a minimum alveolar concentration of 0.6 to 0.8, which will be adjusted to the patient's age to ensure a Bispectral Index (BIS Quatro; Covidien Ilc , Mansfield, MA, USA) between 40-60. Rocuronium will be administered to ensure deep neuromuscular blockade during the study, which will be monitored by train of four neuromuscular relaxation (TOF-watch®, Organon Ltd., Swords, Co. Dublin, Ireland). A tOLA strategy will be applied ten minutes after commencing mechanical ventilation, and it will comprise an alveolar recruitment manoeuver (ARM) with titration of optimal PEEP (PEEPop) on a decremental PEEP trial, followed by a new ARM and setting a tailored open-lung PEEP (tOL-PEEP), that 2 cm H2O higher than PEEPop. All ventilation parameters will remain stable throughout the study except PEEP, which will be titrated according to the principles of tOLA.

A Fluxmed® monitor (MBMED, Buenos Aires, Argentina) will be used for volumetric capnography. The data will be downloaded to a laptop after proper calibration of the flow and pressure sensors. The computer, through the FluxView software (MBMED, Buenos Aires, Argentina), will automatically calculate the following parameters:alveolar, airway and physiological dead spaces (VDalv, VDaw and VDphys, respectively) and its values related to the TV. The anesthesia workstation will be used for continuous monitoring of airway pressures and inspired and expired fraction of the gases administered. The investigators will measure VO2 and SEVOup while applying a low flow anesthesia administration method.

Statistical analysis will be performed by the principal investigator. For data analysis, the statistical software IBM SPSS Statistics for Windows, version 24 (IBM Corp., Armonk, NY, USA) will be used. The investigators will perform an exploratory analysis of the data, using the mean ± standard deviation or the median with interquartile range for quantitative variables. The investigators will use percentages for the analysis of qualitative variables and will check the normality of data distribution with the Kolmogorov-Smirnov test or with the Shapiro-Wilk test for variables with less than 50 records. The Student's t test for paired samples will be used to study the behavior of the quantitative variables at different times (intragroup comparisons). The investigators will also study the correlation between the consumption and uptake estimations (VO2 and SEVOup, respectively) measured as milliliters per minute (ml/min), and the ml/min delivered of both gases through the closed-circuit anesthesia system.

Being tested
VO2 estimation, SEVOup estimation
Keywords
Oxygen Consumption, Sevoflurane, Anesthesia, Closed-Circuit
Medical subject headings
Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VO2 estimationProcedure or surgery

    1. st) VO2 (ml/min) will be estimated based on the formula: Inspired fraction of O2 (FiO2) - Expired fraction of O2 (FeO2) * minute volume (Volmin)
    2. nd) Assuming the estimation of VDphys obtained with Fluxmed®, the investigators will calculate the VO2 corresponding to effective alveolar ventilation (VO2.alv), which will be the result of subtracting VDphys from Volmin.
    3. rd) The investigators will calculate the O2 delivered fraction (DO2) (ml/min) corresponding to the estimated VO2.alv, and will supply it to the system while working in a closed-circuit mode.
  • SEVOup estimationProcedure or surgery

    1. st) SEVOup (ml/min) will be estimated based on the formula: Inspired fraction of sevoflurane (Fi.sevo) - Expired fraction of sevoflurane (Fe.sevo) * Volmin
    2. nd) Assuming the estimation of VDphys obtained with Fluxmed®, the investigators will calculate the SEVOup corresponding to effective alveolar ventilation (SEVOup.alv), which will be the result of subtracting VDphys from Volmin.
    3. rd) The investigators will calculate the sevoflurane delivered fraction (SEVOsuppl) (ml/min) corresponding to the estimated SEVOup.alv, and will supply it to the system while working in a closed-circuit mode.
Study groups in NCT05511584
Study groupRoleWhat they receive
VO2 and SEVOupExperimentalEstimation of VO2 and SEVOup (ml/min) followed by estimation of O2 and sevoflurane supply (DO2 and SEVOsuppl, respectively) through a closed-circuit anesthesia administration system.
Receives: Procedure: VO2 estimation; Procedure: SEVOup estimation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in FeO2 during the closed-circuit ventilation mode

    Any deviation of the expired fractions of O2 (FeO2) with respect to the reference value (this calculated based on VO2.alv estimation). The investigators will reflect this potential deviation through time.

    Measured: Intraoperative ( From the beginning of the maintenance phase of the anesthesia , with recording every 10 minutes or at any time if a deviation of the end-tidal fraction of O2 higher than 5% of the estimated value is detected)

  2. Change in Fe.sevo during the closed-circuit ventilation mode

    Any deviation of the expired fraction of sevoflurane (Fe.sevo) with respect to the reference value (this calculated based on SEVOup.alv estimation). The investigators will reflect this potential deviation through time.

    Measured: Intraoperative (From the beginning of the maintenance phase of the anesthesia , with recording every 10 minutes or at any time if a deviation of the end-tidal fraction of sevoflurane higher than 5% of the estimated value is detected)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2022
  2. Study start1 Feb 2023
  3. Primary completion31 Mar 2024 (estimated)
  4. Study completion31 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05511584
Sponsor's protocol ID
VO2.SEVOup.VDphys
Status last verified
Sep 2023
First submitted
18 Aug 2022
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing VO2 estimation and SEVOup estimation in people with Oxygen Consumption and Sevoflurane, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Manuel de la Matta, MD (0034 647 49 33 62, mdlmatta@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in FeO2 during the closed-circuit ventilation mode (time frame: Intraoperative ( From the beginning of the maintenance phase of the anesthesia , with recording every 10 minutes or at any time if a deviation of the end-tidal fraction of O2 higher than 5% of the estimated value is detected)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

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