Physiological Effects of Positive End-expiratory Pressure With or Without Recruiting Maneuvers in Patients Receiving Low-tidal Volume Ventilation During General Anesthesia for Open Abdominal Surgery. A Randomized, Cross-over Study
Overview
- Phase
- Not Applicable
- Intervention
- Fluid resuscitation or amine administration
- Conditions
- Anesthesia, General
- Sponsor
- Catholic University of the Sacred Heart
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Driving Pressure
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Massimo Antonelli
MD
Catholic University of the Sacred Heart
Eligibility Criteria
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
Arms & Interventions
PEEP2 + RM
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
Intervention: Fluid resuscitation or amine administration
PEEP2 + RM
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
Intervention: General anesthetic
PEEP2 + RM
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
Intervention: Fluid administration
PEEP2 + RM
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
Intervention: Low-tidal volume ventilation
PEEP2 + RM
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
Intervention: Scheduled recruiting maneuvers
PEEP7 + RM
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
Intervention: Fluid resuscitation or amine administration
PEEP7 + RM
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
Intervention: General anesthetic
PEEP7 + RM
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
Intervention: Fluid administration
PEEP7 + RM
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
Intervention: Low-tidal volume ventilation
PEEP7 + RM
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
Intervention: Scheduled recruiting maneuvers
PEEP12 + RM
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
Intervention: Fluid resuscitation or amine administration
PEEP12 + RM
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
Intervention: General anesthetic
PEEP12 + RM
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
Intervention: Fluid administration
PEEP12 + RM
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
Intervention: Low-tidal volume ventilation
PEEP12 + RM
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
Intervention: Scheduled recruiting maneuvers
PEEP2 - RM
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
Intervention: Fluid resuscitation or amine administration
PEEP2 - RM
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
Intervention: General anesthetic
PEEP2 - RM
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
Intervention: Fluid administration
PEEP2 - RM
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
Intervention: Low-tidal volume ventilation
PEEP7 - RM
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
Intervention: Fluid resuscitation or amine administration
PEEP7 - RM
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
Intervention: General anesthetic
PEEP7 - RM
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
Intervention: Fluid administration
PEEP7 - RM
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
Intervention: Low-tidal volume ventilation
PEEP12 - RM.
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
Intervention: Fluid resuscitation or amine administration
PEEP12 - RM.
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
Intervention: General anesthetic
PEEP12 - RM.
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
Intervention: Fluid administration
PEEP12 - RM.
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
Intervention: Low-tidal volume ventilation
Outcomes
Primary Outcomes
Driving Pressure
Time Frame: At the end of each 40-minute step
Respiratory system elastic pressure (Plateau pressure-total PEEP)
Secondary Outcomes
- Oxygenation(At the end of each 40-minute step)
- Vasoactive agents(At the end of each 40-minute step)
- Lung strain(At the end of each 40-minute step)
- Dead space(At the end of each 40-minute step)
- Adverse events(At the end of each 40-minute step)
- Lung overdistension due to PEEP(At the end of each 40-minute step)
- Heart rate(At the end of each 40-minute step)
- Stroke volume(At the end of each 40-minute step)
- Fluid requirements(At the end of each 40-minute step)
- Lung recruitment(At the end of each 40-minute step)
- Stroke volume variation(At the end of each 40-minute step)
- Functional residual capacity(At the end of each 40-minute step)
- Blood pressure(At the end of each 40-minute step)
- Cardiac Output(At the end of each 40-minute step)