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Ventilation Strategy During General Anesthesia for Orthopedic Surgery: A Quality Improvement Project

Not Applicable
Completed
Conditions
Orthopedic Surgery
Ventilation
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
Inclusion Criteria
  • Surgery in orthopedic operating rooms 32-37
  • General anesthesia with endotracheal intubation.
Exclusion Criteria
  • Non-orthopedic procedures;
  • Intubation before induction of anesthesia.

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Composite of Serious Postoperative Pulmonary ComplicationsAfter 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 RatioAfter 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 Daysfrom 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

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