Clinical trial NCT03083457: Physiological Effects of Lung Recruitment During General Anesthesia and Low-tidal Volume Ventilation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, General
Surgery
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each patient will be randomized to receive or not scheduled recruiting maneuvers every hour. In each of the two groups, patients will receive mechanical ventilation with 3 different levels of PEEP in a sequential, randomized, cross-over manner: each period will last 40 minutes.

A randomization sequence will be produced by a dedicated software and sealed envelopes will be used to allocate patients to study treatments.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Driving Pressure
timeFrame: At the end of each 40-minute step
Secondary outcomes:
measure: Lung strain
timeFrame: At the end of each 40-minute step
measure: Dead space
timeFrame: At the end of each 40-minute step
measure: Oxygenation
timeFrame: At the end of each 40-minute step
measure: Lung recruitment
timeFrame: At the end of each 40-minute step
measure: Lung overdistension due to PEEP
timeFrame: At the end of each 40-minute step
measure: Functional residual capacity
timeFrame: At the end of each 40-minute step
measure: Heart rate
timeFrame: At the end of each 40-minute step
measure: Blood pressure
timeFrame: At the end of each 40-minute step
measure: Stroke volume
timeFrame: At the end of each 40-minute step
measure: Stroke volume variation
timeFrame: At the end of each 40-minute step
measure: Cardiac Output
timeFrame: At the end of each 40-minute step
measure: Fluid requirements
timeFrame: At the end of each 40-minute step
measure: Vasoactive agents
timeFrame: At the end of each 40-minute step
measure: Adverse events
timeFrame: At the end of each 40-minute step
Other outcomes:
Locations:
city: Rome
country: Italy
facility: General surgery OR, A. Gemelli hospital
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Massimo Antonelli, MD
role: PRINCIPAL_INVESTIGATOR
References: