Ventilation Strategy During General Anesthesia for Orthopedic Surgery: A Quality Improvement Project
- Conditions
- Orthopedic SurgeryVentilation
- Registration Number
- NCT03657368
- Lead Sponsor
- The Cleveland Clinic
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2860
- Surgery in orthopedic operating rooms 32-37
- General anesthesia with endotracheal intubation.
- Non-orthopedic procedures;
- Intubation before induction of anesthesia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU) After surgery until discharged from PACU or up to 90 minutes 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.
- Secondary Outcome Measures
Name Time Method Composite of Serious Postoperative Pulmonary Complications After surgery from 2 to 5 days 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.
Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio After surgery from 2 to 5 days 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.
Length of Postoperative Hospital Stay by Days from out of operation room to discharge The days of postoperative hospitalization, which from out of operation room to discharge from the hospital, an average of 1 week
Trial Locations
- Locations (1)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation🇺🇸Cleveland, Ohio, United States