Orthopedic SurgeryNCT03657368
Ventilation Strategy During General Anesthesia for Orthopedic Surgery: A Quality Improvement Project
A study testing Low tidal Volume, High tidal Volume and Low PEEP in people with Orthopedic Surgery and Ventilation, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Surgery, Ventilation
- What is being tested?
- Low tidal Volume, High tidal Volume and Low PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,860 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2018to 23 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery in orthopedic operating rooms 32-37
- General anesthesia with endotracheal intubation.
Who cannot join
- Non-orthopedic procedures;
- Intubation before induction of anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Orthopedic Surgery, Ventilation
- Being tested
- Low tidal Volume, High tidal Volume, Low PEEP, High PEEP
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low tidal VolumeProcedure or surgery
Tidal volume = 6 ml/kg predicted body weight
High tidal VolumeProcedure or surgery
Tidal volume = 10 ml/kg predicted body weight
Low PEEPProcedure or surgery
PEEP = 5 cm H2O
High PEEPProcedure or surgery
PEEP = 8 cm H2O
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: High tidal Volume; Procedure: High PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After surgery until discharged from PACU or up to 90 minutes
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: from out of operation room to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start3 Sep 2018
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,860 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alparslan Turan, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657368
- Sponsor's protocol ID
- 18-001
- Status last verified
- Feb 2025
- First submitted
- 31 Aug 2018
- Last updated
- 27 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared on a collaborative basis.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation Strategy During General Anesthesia for Orthopedic Surgery: A Quality Improvement Project
- ClinicalTrials.gov ID
- NCT03657368
- Acronym / sponsor ID
- 18-001
- Conditions
- Orthopedic Surgery, Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,860 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Posted 27 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low tidal volume and low PEEP | Experimental | Procedure: Low tidal Volume, Procedure: Low PEEPVentilation parameters will be set at tidal volume = 6 ml/ kg predicted body weight, and PEEP = 5 cm water (H2O). |
| Low tidal volume and high PEEP | Experimental | Procedure: Low tidal Volume, Procedure: High PEEPVentilation parameters will be set at tidal volume = 6 ml/kg predicted body weight, and PEEP = 8 cm H2O. |
| High tidal volume and low PEEP | Experimental | Procedure: High tidal Volume, Procedure: Low PEEPVentilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 5cm H2O. |
| High tidal volume and high PEEP | Experimental | Procedure: High tidal Volume, Procedure: High PEEPVentilation parameters will be set at tidal volume = 10 ml/kg predicted body weight, and PEEP = 8cm H2O. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgery in orthopedic operating rooms 32-37
- General anesthesia with endotracheal intubation.
Key exclusion criteria (2 listed)
- Non-orthopedic procedures;
- Intubation before induction of anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low tidal VolumeTidal volume = 6 ml/kg predicted body weight | Procedure or surgery | Low tidal volume and high PEEP, Low tidal volume and low PEEP |
| High tidal VolumeTidal volume = 10 ml/kg predicted body weight | Procedure or surgery | High tidal volume and high PEEP, High tidal volume and low PEEP |
| Low PEEPPEEP = 5 cm H2O | Procedure or surgery | High tidal volume and low PEEP, Low tidal volume and low PEEP |
| High PEEPPEEP = 8 cm H2O | Procedure or surgery | High tidal volume and high PEEP, Low tidal volume and high PEEP |
Primary outcome
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.
3 secondary outcomes
Composite of Serious Postoperative Pulmonary Complications
Time frame: After surgery from 2 to 5 days
Oxygenation in Ward, Defined as Time Weighted Average (TWA) of SaO2/FIO2 Ratio
Time frame: After surgery from 2 to 5 days
Length of Postoperative Hospital Stay by Days
Time frame: from out of operation room to discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be shared on a collaborative basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alparslan Turan, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low tidal Volume, High tidal Volume and Low PEEP in people with Orthopedic Surgery and Ventilation, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.