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

NCT ID: NCT03657368

Last Updated: 2025-08-27

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2860 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2020-10-23

Brief Summary

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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

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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

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Orthopedic Surgery Ventilation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Low tidal Volume

Intervention Type PROCEDURE

Tidal volume = 6 ml/kg predicted body weight

Low PEEP

Intervention Type PROCEDURE

PEEP = 5 cm H2O

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.

Group Type EXPERIMENTAL

Low tidal Volume

Intervention Type PROCEDURE

Tidal volume = 6 ml/kg predicted body weight

High PEEP

Intervention Type PROCEDURE

PEEP = 8 cm H2O

High tidal volume and low PEEP

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

Group Type EXPERIMENTAL

High tidal Volume

Intervention Type PROCEDURE

Tidal volume = 10 ml/kg predicted body weight

Low PEEP

Intervention Type PROCEDURE

PEEP = 5 cm H2O

High tidal volume and high PEEP

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

Group Type EXPERIMENTAL

High tidal Volume

Intervention Type PROCEDURE

Tidal volume = 10 ml/kg predicted body weight

High PEEP

Intervention Type PROCEDURE

PEEP = 8 cm H2O

Interventions

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Low tidal Volume

Tidal volume = 6 ml/kg predicted body weight

Intervention Type PROCEDURE

High tidal Volume

Tidal volume = 10 ml/kg predicted body weight

Intervention Type PROCEDURE

Low PEEP

PEEP = 5 cm H2O

Intervention Type PROCEDURE

High PEEP

PEEP = 8 cm H2O

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Non-orthopedic procedures;
* Intubation before induction of anesthesia.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alparslan Turan, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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18-001

Identifier Type: -

Identifier Source: org_study_id

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