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Ventilation Strategies for Orthopedic Surgery

N/A
Waitlist Available
Led By Alparslan Turan, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
General anesthesia with endotracheal intubation
Surgery in orthopedic operating rooms 32-37
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 2 to 5 days
Awards & highlights

Study Summary

This trial is looking at what combination of two things--tidal volume (the amount of air you breathe in) and positive end-expiratory pressure (a pressure that helps keep air in your lungs)--is best for patients during surgery.

Who is the study for?
This trial is for patients undergoing elective orthopedic surgery in specific operating rooms, who will receive general anesthesia with endotracheal intubation. It's not open to those having non-orthopedic procedures or those intubated before anesthesia induction.Check my eligibility
What is being tested?
The study is testing different combinations of breathing support settings during surgery: low vs high amounts of air per breath (tidal volume) and low vs high pressure after exhalation (PEEP). The goal is to find the best mix for a faster recovery.See study design
What are the potential side effects?
Potential side effects may include discomfort from the breathing tube, lung complications due to varying pressures and volumes, and possible impacts on oxygen levels or blood pressure during surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will be put to sleep with a tube in my windpipe for surgery.
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My surgery will be in an orthopedic operating room numbered 32 to 37.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after surgery until discharged from pacu or up to 90 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and after surgery until discharged from pacu or up to 90 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time-weighted average SaO2/FiO2 ratio in the postanesthesia care unit (PACU)
Secondary outcome measures
Composite of serious postoperative pulmonary complications
Length of postoperative hospital stay
Oxygenation in ward, defined as SaO2/FIO2 ratio
Other outcome measures
Exploratory objective
Exploratory outcome

Trial Design

4Treatment groups
Experimental Treatment
Group I: Low tidal volume and low PEEPExperimental Treatment2 Interventions
Ventilation parameters will be set at tidal volume = 6 ml/ kg predicted body weight, and PEEP = 5 cm water (H2O).
Group II: Low tidal volume and high PEEPExperimental Treatment2 Interventions
Ventilation parameters will be set at tidal volume = 6 ml/kg predicted body weight, and PEEP = 8 cm H2O.
Group III: High tidal volume and low PEEPExperimental Treatment2 Interventions
Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 5cm H2O.
Group IV: High tidal volume and high PEEPExperimental Treatment2 Interventions
Ventilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 8cm H2O.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low PEEP
2014
N/A
~4590
High PEEP
2019
N/A
~3840

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,363,189 Total Patients Enrolled
Alparslan Turan, MDPrincipal InvestigatorThe Cleveland Clinic
7 Previous Clinical Trials
2,437 Total Patients Enrolled

Media Library

Low PEEP Clinical Trial Eligibility Overview. Trial Name: NCT03657368 — N/A
Orthopedic Procedures Research Study Groups: High tidal volume and high PEEP, Low tidal volume and high PEEP, High tidal volume and low PEEP, Low tidal volume and low PEEP
Orthopedic Procedures Clinical Trial 2023: Low PEEP Highlights & Side Effects. Trial Name: NCT03657368 — N/A
Low PEEP 2023 Treatment Timeline for Medical Study. Trial Name: NCT03657368 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
AnesthesiologyJournal
Tidal Volume and Positive End-expiratory Pressure and Postoperative Hypoxemia During General Anesthesia: A Single-center Multiple Crossover Factorial Cluster Trial
Turan, Alparslan, Wael Ali Sakr Esa, Eva Rivas, Jiayi Wang, Omer Bakal, Samantha Stamper, Ehab Farag, et al.. 2022. “Tidal Volume and Positive End-expiratory Pressure and Postoperative Hypoxemia During General Anesthesia: A Single-center Multiple Crossover Factorial Cluster Trial”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aln.0000000000004342.
clinicaltrials.govStudy
Ventilation Strategy During General Anesthesia for Orthopedic Surgery
2018. "Ventilation Strategy During General Anesthesia for Orthopedic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03657368.
All > Anesthesia > Orthopedic
~439 spots leftby Apr 2025
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