NCT03083457

Physiological Effects of Lung Recruitment During General Anesthesia and Low-tidal Volume Ventilation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia, General
• Surgery

Interventions

Type	Name	Description
DRUG	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
DRUG	General anesthetic	Total intravenous anesthesia with a standard protocol
DRUG	Fluid administration	3-5 ml/kg of balanced crystalloids will be administered throughout the whole surgical procedure
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
PROCEDURE	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

Timeline

• Start date: 2017-03-20
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2017-03-20
• Last updated: 2021-01-29

Locations

1 site across 1 country: Italy