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Completed

NCT Number: NCT03657368

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.

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Key information

Conditions

Orthopedic Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Low tidal volume

Procedure

Tidal volume = 6 ml/kg predicted body weight

high tidal volume

Procedure

Tidal volume = 10 ml/kg predicted body weight

Low PEEP

Procedure

PEEP = 5 cm H2O

High PEEP

Procedure

PEEP = 8 cm H2O

Primary outcomes

  1. 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

  1. Composite of Serious Postoperative Pulmonary Complications

    Time frame: After 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.

  2. Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio

    Time frame: After 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.

  3. Length of Postoperative Hospital Stay by Days

    Time frame: from 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

Other outcomes

  1. Patients Need of Oxygen in Ward After Surgery

    Time frame: from out of operation room to discharge from the hospital

    number of patients who need of Oxygen in ward after surgery during hospital stay

  2. Patients With Unplanned ICU Admission

    Time frame: from out of operation room to discharge from the hospital

    number of patients with unplanned ICU admission after surgery in hospital stay

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 5, 2018
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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