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

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.

Study Overview

• Status: Completed
• Conditions: Ventilation; Orthopedic Surgery
• Intervention / Treatment: Procedure: Low tidal Volume; Procedure: Low PEEP; Procedure: High PEEP; Procedure: High tidal Volume

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.

• Study Type: Interventional
• Enrollment (Actual): 2860
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low tidal volume and low PEEP; Ventilation parameters will be set at tidal volume = 6 ml/ kg predicted body weight, and PEEP = 5 cm water (H2O).	Procedure: Low tidal Volume; Tidal volume = 6 ml/kg predicted body weight; Procedure: Low PEEP; PEEP = 5 cm H2O
Experimental: Low tidal volume and high PEEP; Ventilation parameters will be set at tidal volume = 6 ml/kg predicted body weight, and PEEP = 8 cm H2O.	Procedure: Low tidal Volume; Tidal volume = 6 ml/kg predicted body weight; Procedure: High PEEP; PEEP = 8 cm H2O
Experimental: High tidal volume and low PEEP; Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 5cm H2O.	Procedure: Low PEEP; PEEP = 5 cm H2O; Procedure: High tidal Volume; Tidal volume = 10 ml/kg predicted body weight
Experimental: High tidal volume and high PEEP; Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 8cm H2O.	Procedure: High PEEP; PEEP = 8 cm H2O; Procedure: High tidal Volume; Tidal volume = 10 ml/kg predicted body weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After surgery until discharged from PACU or up to 90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	from out of operation room to discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients Need of Oxygen in Ward After Surgery	number of patients who need of Oxygen in ward after surgery during hospital stay	from out of operation room to discharge from the hospital
Patients With Unplanned ICU Admission	number of patients with unplanned ICU admission after surgery in hospital stay	from out of operation room to discharge from the hospital

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Alparslan Turan, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2018
• Primary Completion (Actual): October 23, 2020
• Study Completion (Actual): October 23, 2020

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Aspiration
• Other Study ID Numbers: 18-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared on a collaborative basis.
• IPD Sharing Time Frame: After publication of the primary manuscript.
• IPD Sharing Access Criteria: Data will be shared on a collaborative basis with investigators who plan substantive sub-analyses.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No