NCT03657368

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,860 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orthopedic Surgery
• Ventilation

Interventions

Type	Name	Description
PROCEDURE	Low tidal Volume	Tidal volume = 6 ml/kg predicted body weight
PROCEDURE	High tidal Volume	Tidal volume = 10 ml/kg predicted body weight
PROCEDURE	Low PEEP	PEEP = 5 cm H2O
PROCEDURE	High PEEP	PEEP = 8 cm H2O

Timeline

• Start date: 2018-09-03
• Primary completion: 2020-10-23
• Completion: 2020-10-23
• First posted: 2018-09-05
• Last updated: 2025-08-27
• Results posted: 2025-08-27

Locations

1 site across 1 country: United States