The objective is to determine the optimal intraoperative ventilation strategy among the chosen tidal volume and positive end-expiratory pressure (PEEP) levels, and standardize it in an enhanced recovery pathway for orthopedic surgical patients. In particular, we propose to determine which combination of intraoperative tidal volume and positive end-expiratory pressure is best for patients having elective orthopedic surgery.
This is a non-randomized alternating intervention cohort study in which all orthopedic surgery operating rooms will alternate amongst four designated ventilation settings which include two tidal volumes and two PEEP levels. At the end of the four-week sequence, the entire sequence will be repeated 26 times over a 2-year period. Thus, ventilator settings will not be randomized on a per-patient basis, or even among study weeks. Ventilation parameters will be designated at the beginning of each study week. However, clinicians will be free to adjust to whatever ventilation settings they believe is optimal in individual patients to ensure oxygenation and patient safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,860
Tidal volume = 6 ml/kg predicted body weight
Tidal volume = 10 ml/kg predicted body weight
PEEP = 5 cm H2O
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU)
Primary outcome was oxygenation in the postoperative care unit, defined by the peripheral oxygen saturation divided by the fraction of inspired oxygen (SpO2/FiO2 ratio), a validated measure of acute lung injury.
Time frame: After surgery until discharged from PACU or up to 90 minutes
Composite of Serious Postoperative Pulmonary Complications
Postoperative diagnoses will be collected from electronic medical records of patients. Individual chart reviews (blinded to ventilation management) will confirm that terms of the composite are met will be performed.
Time frame: After surgery from 2 to 5 days
Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio
Oxygen administration and SaO2 are normally recorded at 4-hour intervals on surgical wards. The time weighted average (TWA) of overall SaO2/FIO2 ratio will be compared among different ventilation strategies.
Time frame: After surgery from 2 to 5 days
Length of Postoperative Hospital Stay by Days
The days of postoperative hospitalization, which from out of operation room to discharge from the hospital, an average of 1 week
Time frame: from out of operation room to discharge
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PEEP = 8 cm H2O