Physiological Effects of Lung Recruitment During General Anesthesia and Low-tidal Volume Ventilation
NCT ID: NCT03083457
Last Updated: 2021-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2017-03-20
2020-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
A randomization sequence will be produced by a dedicated software and sealed envelopes will be used to allocate patients to study treatments.
TREATMENT
SINGLE
Study Groups
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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
Fluid resuscitation or amine administration
Fluid administration or amine administration if deemed necessary by the attending physician. Haemodynamics will be monitored through noninvasive cardiac output assessment by arterial pulse contour analysis
General anesthetic
Total intravenous anesthesia with a standard protocol
Fluid administration
3-5 ml/kg of balanced crystalloids will be administered throughout the whole surgical procedure
Low-tidal volume ventilation
Volume-control ventilation with tidal volume=7 ml/kg of predicted body weight for the entire surgical procedure. Respiratory rate will be set to maintain EtCO2 within a physiological range and kept unchanged for the entire duration of the study
Scheduled recruiting maneuvers
Pressure-control ventilation inspiratory pressure=10 cmH2O. Steplike 5-cmH2O-PEEP increase every 30 seconds to achieve a peep of 35 cmH2O, followed by 5-cmH2O-PEEP reduction every 30 seconds to set PEEP
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
Fluid resuscitation or amine administration
Fluid administration or amine administration if deemed necessary by the attending physician. Haemodynamics will be monitored through noninvasive cardiac output assessment by arterial pulse contour analysis
General anesthetic
Total intravenous anesthesia with a standard protocol
Fluid administration
3-5 ml/kg of balanced crystalloids will be administered throughout the whole surgical procedure
Low-tidal volume ventilation
Volume-control ventilation with tidal volume=7 ml/kg of predicted body weight for the entire surgical procedure. Respiratory rate will be set to maintain EtCO2 within a physiological range and kept unchanged for the entire duration of the study
Scheduled recruiting maneuvers
Pressure-control ventilation inspiratory pressure=10 cmH2O. Steplike 5-cmH2O-PEEP increase every 30 seconds to achieve a peep of 35 cmH2O, followed by 5-cmH2O-PEEP reduction every 30 seconds to set PEEP
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
Fluid resuscitation or amine administration
Fluid administration or amine administration if deemed necessary by the attending physician. Haemodynamics will be monitored through noninvasive cardiac output assessment by arterial pulse contour analysis
General anesthetic
Total intravenous anesthesia with a standard protocol
Fluid administration
3-5 ml/kg of balanced crystalloids will be administered throughout the whole surgical procedure
Low-tidal volume ventilation
Volume-control ventilation with tidal volume=7 ml/kg of predicted body weight for the entire surgical procedure. Respiratory rate will be set to maintain EtCO2 within a physiological range and kept unchanged for the entire duration of the study
Scheduled recruiting maneuvers
Pressure-control ventilation inspiratory pressure=10 cmH2O. Steplike 5-cmH2O-PEEP increase every 30 seconds to achieve a peep of 35 cmH2O, followed by 5-cmH2O-PEEP reduction every 30 seconds to set PEEP
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
Fluid resuscitation or amine administration
Fluid administration or amine administration if deemed necessary by the attending physician. Haemodynamics will be monitored through noninvasive cardiac output assessment by arterial pulse contour analysis
General anesthetic
Total intravenous anesthesia with a standard protocol
Fluid administration
3-5 ml/kg of balanced crystalloids will be administered throughout the whole surgical procedure
Low-tidal volume ventilation
Volume-control ventilation with tidal volume=7 ml/kg of predicted body weight for the entire surgical procedure. Respiratory rate will be set to maintain EtCO2 within a physiological range and kept unchanged for the entire duration of the study
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
Fluid resuscitation or amine administration
Fluid administration or amine administration if deemed necessary by the attending physician. Haemodynamics will be monitored through noninvasive cardiac output assessment by arterial pulse contour analysis
General anesthetic
Total intravenous anesthesia with a standard protocol
Fluid administration
3-5 ml/kg of balanced crystalloids will be administered throughout the whole surgical procedure
Low-tidal volume ventilation
Volume-control ventilation with tidal volume=7 ml/kg of predicted body weight for the entire surgical procedure. Respiratory rate will be set to maintain EtCO2 within a physiological range and kept unchanged for the entire duration of the study
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
Fluid resuscitation or amine administration
Fluid administration or amine administration if deemed necessary by the attending physician. Haemodynamics will be monitored through noninvasive cardiac output assessment by arterial pulse contour analysis
General anesthetic
Total intravenous anesthesia with a standard protocol
Fluid administration
3-5 ml/kg of balanced crystalloids will be administered throughout the whole surgical procedure
Low-tidal volume ventilation
Volume-control ventilation with tidal volume=7 ml/kg of predicted body weight for the entire surgical procedure. Respiratory rate will be set to maintain EtCO2 within a physiological range and kept unchanged for the entire duration of the study
Interventions
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Fluid resuscitation or amine administration
Fluid administration or amine administration if deemed necessary by the attending physician. Haemodynamics will be monitored through noninvasive cardiac output assessment by arterial pulse contour analysis
General anesthetic
Total intravenous anesthesia with a standard protocol
Fluid administration
3-5 ml/kg of balanced crystalloids will be administered throughout the whole surgical procedure
Low-tidal volume ventilation
Volume-control ventilation with tidal volume=7 ml/kg of predicted body weight for the entire surgical procedure. Respiratory rate will be set to maintain EtCO2 within a physiological range and kept unchanged for the entire duration of the study
Scheduled recruiting maneuvers
Pressure-control ventilation inspiratory pressure=10 cmH2O. Steplike 5-cmH2O-PEEP increase every 30 seconds to achieve a peep of 35 cmH2O, followed by 5-cmH2O-PEEP reduction every 30 seconds to set PEEP
Eligibility Criteria
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Inclusion Criteria
* 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
* BMI\>30 kg/m\^2
* hepatic surgery
* Cardiac failure NYHA\>2
* History of chronic respiratory failure
18 Years
ALL
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Responsible Party
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Massimo Antonelli
MD
Principal Investigators
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Massimo Antonelli, MD
Role: PRINCIPAL_INVESTIGATOR
Catholic University of the Sacred Heart
Locations
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General surgery OR, A. Gemelli hospital
Rome, , Italy
Countries
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Other Identifiers
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10989/15
Identifier Type: -
Identifier Source: org_study_id
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