Oxygen Consumption and Sevoflurane Uptake Based on Physiological Dead Space Estimation

NCT05511584 | Unknown

• 1 other identifier: VO2.SEVOup.VDphys
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Oxygen Consumption; Sevoflurane; Anesthetics, Inhalation; Surgery

Keywords

Oxygen Consumption; Sevoflurane; Anesthesia, Closed-Circuit

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

• 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.

  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)

Study Arms (1)

VO2 and SEVOup

EXPERIMENTAL

Estimation 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.

Procedure: VO2 estimation; Procedure: SEVOup estimation

Interventions

VO2 estimation PROCEDURE

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.

VO2 and SEVOup

SEVOup estimation PROCEDURE

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.

VO2 and SEVOup

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel de la Matta, MD

  Hospitales Universitarios Virgen del Rocío

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel de la Matta, MD

CONTACT

0034 647 49 33 62; mdlmatta@hotmail.com

Manuel de la Matta, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 23, 2022
• Study Start: February 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: October 31, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

ES (1)