Physiological Effects of Lung Recruitment During General Anesthesia and Low-tidal Volume Ventilation
Not Applicable
Completed
- Conditions
- Anesthesia, GeneralSurgery
- Interventions
- Drug: Fluid resuscitation or amine administrationDrug: General anestheticDrug: Fluid administrationProcedure: Low-tidal volume ventilationProcedure: Scheduled recruiting maneuvers
- Registration Number
- NCT03083457
- Lead Sponsor
- Catholic University of the Sacred Heart
- Brief Summary
Low-tidal volume ventilation is arising as a tool to optimize the ventilatory management and to improve clinical outcome in patients undergoing general anesthesia for abdominal surgery.
A recent large randomized controlled trial failed to detect a significant difference between two different approaches for ensuring adequate lung recruitment (PEEP=12 cmH2O + scheduled recruiting maneuvers vs. PEEP 2 cmH2O) during protective ventilation. Thus, in patients undergoing open abdominal surgery and receiving low-tidal volumes, the effects of different positive end-expiratory pressure (PEEP) levels and recruiting maneuvers remain to be established.
Design: prospective, cross-over, physiological trial.
PURPOSE To assess the physiological effects of different PEEP levels with or without scheduled recruiting maneuvers in patients undergoing general anesthesia for open abdominal surgery and receiving low-tidal volume ventilation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- ASA physical status I-II patients
- scheduled for open abdominal surgery (major gastrointestinal surgery: duodeno-cephalo-pancreatectomy, gastrectomy, hemi-colectomy; gynecological surgery; oncologic surgery)
- Expected duration of surgery >= 150 minutes
Exclusion Criteria
- Pregnancy
- BMI>30 kg/m^2
- hepatic surgery
- Cardiac failure NYHA>2
- History of chronic respiratory failure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PEEP12 + RM Low-tidal volume ventilation General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP7 + RM General anesthetic General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP7 + RM Scheduled recruiting maneuvers General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP12 + RM Fluid resuscitation or amine administration General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP12 + RM General anesthetic General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP2 - RM Fluid resuscitation or amine administration General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP12 - RM. Fluid administration General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP12 - RM. Low-tidal volume ventilation General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP2 + RM General anesthetic General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O and scheduled recruiting maneuvers at the beginning of each PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP2 + RM Scheduled recruiting maneuvers General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O and scheduled recruiting maneuvers at the beginning of each PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP7 - RM Low-tidal volume ventilation General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP12 - RM. General anesthetic General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP2 + RM Fluid resuscitation or amine administration General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O and scheduled recruiting maneuvers at the beginning of each PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP2 + RM Low-tidal volume ventilation General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O and scheduled recruiting maneuvers at the beginning of each PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP7 + RM Fluid administration General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP7 + RM Low-tidal volume ventilation General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP12 + RM Fluid administration General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP12 + RM Scheduled recruiting maneuvers General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP2 + RM Fluid administration General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O and scheduled recruiting maneuvers at the beginning of each PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP7 + RM Fluid resuscitation or amine administration General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP2 - RM Low-tidal volume ventilation General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP7 - RM Fluid resuscitation or amine administration General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP2 - RM General anesthetic General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP7 - RM General anesthetic General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP2 - RM Fluid administration General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP7 - RM Fluid administration General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study PEEP12 - RM. Fluid resuscitation or amine administration General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study
- Primary Outcome Measures
Name Time Method Driving Pressure At the end of each 40-minute step Respiratory system elastic pressure (Plateau pressure-total PEEP)
- Secondary Outcome Measures
Name Time Method Oxygenation At the end of each 40-minute step PaO2/FiO2
Vasoactive agents At the end of each 40-minute step Vasoactive agents requirements, according to the decision of the attending physician blinded to the design of the study
Lung strain At the end of each 40-minute step Lung static and dynamic strain
Dead space At the end of each 40-minute step Approximated as the difference between End-tidal CO2 and PaCO2 divided by PaCO2
Adverse events At the end of each 40-minute step Adverse events
Lung overdistension due to PEEP At the end of each 40-minute step % (lung overdistension/change in end-expiratory lung volume)
Heart rate At the end of each 40-minute step heart rate
Stroke volume At the end of each 40-minute step Stroke volume, measured by pulse contour analysis
Fluid requirements At the end of each 40-minute step Fluid bolus requirements, according to the decision of the attending physician blinded to the design of the study
Lung recruitment At the end of each 40-minute step % (lung recruitment/change in end-expiratory lung volume)
Stroke volume variation At the end of each 40-minute step Stroke volume variation, measured by pulse contour analysis
Functional residual capacity At the end of each 40-minute step Change in functional residual capacity due to PEEP, measured with the Nitrogen washin-washout technique
Blood pressure At the end of each 40-minute step Arterial blood pressure
Cardiac Output At the end of each 40-minute step Stroke volume x heart rate
Trial Locations
- Locations (1)
General surgery OR, A. Gemelli hospital
🇮🇹Rome, Italy