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

NCT03657368 | Completed Results DMC

• 1 other identifier: 18-001
• Study Type: interventional
• Target: 2,860
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Surgery; Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Other Outcomes (2)

• Patients Need of Oxygen in Ward After Surgery

  from out of operation room to discharge from the hospital

• Patients With Unplanned ICU Admission

  from out of operation room to discharge from the hospital

Study Arms (4)

Low tidal volume and low PEEP

EXPERIMENTAL

Ventilation parameters will be set at tidal volume = 6 ml/ kg predicted body weight, and PEEP = 5 cm water (H2O).

Procedure: Low tidal Volume; Procedure: Low PEEP

Low tidal volume and high PEEP

EXPERIMENTAL

Ventilation parameters will be set at tidal volume = 6 ml/kg predicted body weight, and PEEP = 8 cm H2O.

Procedure: Low tidal Volume; Procedure: High PEEP

High tidal volume and low PEEP

EXPERIMENTAL

Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 5cm H2O.

Procedure: High tidal Volume; Procedure: Low PEEP

High tidal volume and high PEEP

EXPERIMENTAL

Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 8cm H2O.

Procedure: High tidal Volume; Procedure: High PEEP

Interventions

Low tidal Volume PROCEDURE

Tidal volume = 6 ml/kg predicted body weight

Low tidal volume and high PEEP; Low tidal volume and low PEEP

High tidal Volume PROCEDURE

Tidal volume = 10 ml/kg predicted body weight

High tidal volume and high PEEP; High tidal volume and low PEEP

Low PEEP PROCEDURE

PEEP = 5 cm H2O

High tidal volume and low PEEP; Low tidal volume and low PEEP

High PEEP PROCEDURE

PEEP = 8 cm H2O

High tidal volume and high PEEP; Low tidal volume and high PEEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: YanYan Han
• Organization: Cleveland Clinic Foundation

HANY3@ccf.org

216-444-2250

Study Officials

• Alparslan Turan, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 5, 2018
• Study Start: September 3, 2018
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: August 27, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication of the primary manuscript.
• Access Criteria: Data will be shared on a collaborative basis with investigators who plan substantive sub-analyses.

Locations

US (1)