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Clinical Trials/NCT03657368
NCT03657368
Completed
Not Applicable

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

The Cleveland Clinic1 site in 1 country2,860 target enrollmentSeptember 3, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Orthopedic Surgery
Sponsor
The Cleveland Clinic
Enrollment
2860
Locations
1
Primary Endpoint
Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU)
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 3, 2018
End Date
October 23, 2020
Last Updated
8 months ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Surgery in orthopedic operating rooms 32-37
  • General anesthesia with endotracheal intubation.

Exclusion Criteria

  • Non-orthopedic procedures;
  • Intubation before induction of anesthesia.

Outcomes

Primary Outcomes

Time-weighted Average SaO2/FiO2 Ratio in the Postanesthesia Care Unit (PACU)

Time Frame: 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 Outcomes

  • Composite of Serious Postoperative Pulmonary Complications(After surgery from 2 to 5 days)
  • Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio(After surgery from 2 to 5 days)
  • Length of Postoperative Hospital Stay by Days(from out of operation room to discharge)

Study Sites (1)

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