Cardiac SurgeryNCT04978636
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
A study testing Continuous low-tidal volume ventilation with using FiO2 of 0.21, Continuous low tidal volume ventilation with using FiO2 of 1.0 and Apnea During CPB in people with Cardiac Surgery, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This is a multi-institutional study (CCF, UPMC, OSU) evaluating different ventilation strategies during cardiopulmonary bypass on mortality and postoperative pulmonary complications, with sub-study investigating 8-iso-prostaglandin F2a and sRAGE levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Continuous low-tidal volume ventilation with using FiO2 of 0.21, Continuous low tidal volume ventilation with using FiO2 of 1.0 and Apnea During CPB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,502 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- >18 years of age
- Male and female patients undergoing elective cardiac surgeries requiring cardiopulmonary bypass.
Who cannot join
- Emergency surgeries, surgeries requiring lung isolation and one-lung ventilation (OLV), heart or lung transplants, and mechanical circulatory support device implantation pulmonary thrombendarterectomies.
- Surgeries requiring one-lung ventilation will be excluded because of the inability to employ study intervention and the differential treatment of the lungs likely confounding any potential effect from the planned intervention.
- Lung transplant surgeries will be excluded for similar reasons as well as other confounding effects affecting the primary composite outcome.
- Heart transplants and mechanical circulatory support device implantation surgeries will be excluded because these patients already receive intervention as part of the institutional protocol at the primary study site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The eFfect of cOntinuous Low Tidal Volume Ventilation With Hyperoxia Avoidance During CardiopUlmonary Bypass "FOCUS" Trial Blood Samples
This is a multi-institutional study (CCF, UPMC, OSU) evaluating different ventilation strategies during cardiopulmonary bypass on mortality and postoperative pulmonary complications, with sub-study investigating 8-iso-prostaglandin F2a and sRAGE levels.
Read the detailed description
The investigators will evaluate the effect of low tidal volume with varying FiO2 fractions during cardiopulmonary bypass on postoperative mortality and pulmonary complications. This will be a prospective, pragmatic, cluster randomized trial including all eligible adult cardiac surgical patients requiring cardiopulmonary bypass. Each week, all operating rooms will be randomized to one of three possible ventilation strategies during the period of cardiopulmonary bypass: 1) continuous low tidal volume ventilation with inspired oxygen fraction at 1.0, 2) continuous low tidal volume ventilation with inspired oxygen fraction at 0.21, and 3) no ventilation (apnea). The investigators will anticipate increase in plasma sRAGE and 8-iso-prostaglandin F2a levels in all three groups of patients during CPB with the highest levels immediately after cross-clamp release. The investigators will anticipate significant difference with at least 25% lower sRAGE levels in this group. The sub-study will also provide preliminary data on the behavior of the 8-iso-prostaglandin F2a which will be useful in further investigation of other targeted interventions to reduce ischemia-reperfusion injury to the lung during routine cardiac surgical operations.
- Conditions
- Cardiac Surgery
- Being tested
- Continuous low-tidal volume ventilation with using FiO2 of 0.21, Continuous low tidal volume ventilation with using FiO2 of 1.0, Apnea During CPB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous low-tidal volume ventilation with using FiO2 of 0.21Other
The continuous low-tidal volume ventilation with using FiO2 of 0.21 will be defined as the tidal volume of 3 mL/kg IBW (up to maximum 200 mL), 0.21 of FiO2, respiratory rate of 5 per minute, and PEEP 5 cm H20). A recruitment maneuver with 30 cm H2O for 10 seconds will be performed before starting the selected ventilation mode in all patients. During the sub-study extra blood samples will be drawn before and after CPB.
Continuous low tidal volume ventilation with using FiO2 of 1.0Other
The continuous low-tidal volume ventilation with using FiO2 of 1.0 will be defined as the tidal volume of 3 mL/kg IBW (up to maximum 200 mL), 1.0 of FiO2, respiratory rate of 5 per minute, and PEEP 5 cm H20). A recruitment maneuver with 30 cm H2O for 10 seconds will be performed before starting the selected ventilation mode in all patients. During the sub-study extra blood samples will be drawn before and after CPB.
Apnea During CPBOther
There will be no ventilation used. But, during the sub-study part of the Apnea CPB extra blood samples will be drawn before and after CPB.
| Study group | Role | What they receive |
|---|---|---|
| Continuous low-tidal volume ventilation with using FiO2 of 0.21 | Active comparator | The investigator will investigate the effect of continuous low tidal volume ventilation with hyperoxia avoidance (using FiO2 of 0.21) on PPCs and 30-day mortality compared to low-tidal volume ventilation (with FiO2 of 0.21) or apnea during CPB, and during the sub-study. Receives: Other: Continuous low-tidal volume ventilation with using FiO2 of 0.21 |
| Continuous low tidal volume ventilation with using FiO2 of 1.0 | Active comparator | The investigator will investigate the effect of low tidal volume lung ventilation with hyperoxia avoidance (FiO2 of 0.21) on PPCs and mortality compared to hyperoxic low-tidal volume ventilation (with FiO2 of 1.0) or apnea during CPB, and during the sub-study. Receives: Other: Continuous low tidal volume ventilation with using FiO2 of 1.0 |
| Apnea | Active comparator | The investigator will investigate the effect of apnea during on PPCs and mortality compared to hyperoxic low-tidal volume ventilation (with FiO2 of 1.0) or hyperoxia avoidance (FiO2 of 0.21) during CPB, and during the sub-study.. Receives: Other: Apnea During CPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Composite including STS 30 day Mortality and postoperative pulmonary complications
Composite including STS 30-day mortality and postoperative pulmonary complications defined a early respiratory failure defined as PaO2/FiO2 ratio<200 mmHg at any time within the first 24 hours of ICU admission, postoperative reintubation during the hospital stay, prolonged ventilation, pneumonia, pleural effusion requiring drainage, pneumothorax requiring intervention, and readmission due to: pleural effusion requiring intervention, or pneumonia.
Measured: Within 30 days of surgery
Secondary outcomes (10)
CPB time
Duration of cardiopulmonary bypass (STS defined)
Measured: During surgery
ICU LOS
ICU length of stay (STS defined)
Measured: Within 30 days of surgery
Early respiratory failure - PaO2/FiO2 ratio < 200 mmHg at any time within the first 24 hours of ICU admission
PaO2/FiO2 ratio < 200 mmHg at any time within the first 24 hours of ICU admission
Measured: 24 hours
Hospital LOS
Hospital length of stay (STS defined)
Measured: Within 30 days of surgery
Reintubation
Reintubation (STS defined)
Measured: Within 30 days of surgery
Need for tracheostomy
Need for tracheostomy (STS defined)
Measured: Within 30 days of surgery
Pleural effusion requiring drainage
Pleural effusion requiring drainage (STS defined)
Measured: Within 30 days of surgery
Pneumonia
Pneumonia (STS defined)
Measured: Within 30 days of surgery
Readmission
Readmission due to respiratory complication or need for thoracentesis and chest tube insertion (STS defined)
Measured: within 30 days of surgery
30-day mortality
STS defined in hospital mortality
Measured: Within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start20 Sep 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5,502 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Cardiovascular Anesthesiologists, University of Pittsburgh Medical Center, Ohio State University
- Responsible party
- Principal investigator, Marta Kelava, MD, The Cleveland Clinic
- Investigators
- Marta Kelava, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978636
- Sponsor's protocol ID
- 21-447
- Status last verified
- Oct 2026
- First submitted
- 20 Jul 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The eFfect of cOntinuous Low Tidal Volume Ventilation With Hyperoxia Avoidance During CardiopUlmonary Bypass "FOCUS" Trial Blood Samples
- ClinicalTrials.gov ID
- NCT04978636
- Acronym / sponsor ID
- 21-447
- Conditions
- Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,502 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Society of Cardiovascular Anesthesiologists, University of Pittsburgh Medical Center, Ohio State University
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-institutional study (CCF, UPMC, OSU) evaluating different ventilation strategies during cardiopulmonary bypass on mortality and postoperative pulmonary complications, with sub-study investigating 8-iso-prostaglandin F2a and sRAGE levels.
Detailed description
The investigators will evaluate the effect of low tidal volume with varying FiO2 fractions during cardiopulmonary bypass on postoperative mortality and pulmonary complications. This will be a prospective, pragmatic, cluster randomized trial including all eligible adult cardiac surgical patients requiring cardiopulmonary bypass. Each week, all operating rooms will be randomized to one of three possible ventilation strategies during the period of cardiopulmonary bypass: 1) continuous low tidal volume ventilation with inspired oxygen fraction at 1.0, 2) continuous low tidal volume ventilation with inspired oxygen fraction at 0.21, and 3) no ventilation (apnea). The investigators will anticipate increase in plasma sRAGE and 8-iso-prostaglandin F2a levels in all three groups of patients during CPB with the highest levels immediately after cross-clamp release. The investigators will anticipate significant difference with at least 25% lower sRAGE levels in this group. The sub-study will also provide preliminary data on the behavior of the 8-iso-prostaglandin F2a which will be useful in further investigation of other targeted interventions to reduce ischemia-reperfusion injury to the lung during routine cardiac surgical operations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous low-tidal volume ventilation with using FiO2 of 0.21 | Active comparator | Other: Continuous low-tidal volume ventilation with using FiO2 of 0.21The investigator will investigate the effect of continuous low tidal volume ventilation with hyperoxia avoidance (using FiO2 of 0.21) on PPCs and 30-day mortality compared to low-tidal volume ventilation (with FiO2 of 0.21) or apnea during CPB, and during the sub-study. |
| Continuous low tidal volume ventilation with using FiO2 of 1.0 | Active comparator | Other: Continuous low tidal volume ventilation with using FiO2 of 1.0The investigator will investigate the effect of low tidal volume lung ventilation with hyperoxia avoidance (FiO2 of 0.21) on PPCs and mortality compared to hyperoxic low-tidal volume ventilation (with FiO2 of 1.0) or apnea during CPB, and during the sub-study. |
| Apnea | Active comparator | Other: Apnea During CPBThe investigator will investigate the effect of apnea during on PPCs and mortality compared to hyperoxic low-tidal volume ventilation (with FiO2 of 1.0) or hyperoxia avoidance (FiO2 of 0.21) during CPB, and during the sub-study.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years of age
- Male and female patients undergoing elective cardiac surgeries requiring cardiopulmonary bypass.
Key exclusion criteria (4 listed)
- Emergency surgeries, surgeries requiring lung isolation and one-lung ventilation (OLV), heart or lung transplants, and mechanical circulatory support device implantation pulmonary thrombendarterectomies.
- Surgeries requiring one-lung ventilation will be excluded because of the inability to employ study intervention and the differential treatment of the lungs likely confounding any potential effect from the planned intervention.
- Lung transplant surgeries will be excluded for similar reasons as well as other confounding effects affecting the primary composite outcome.
- Heart transplants and mechanical circulatory support device implantation surgeries will be excluded because these patients already receive intervention as part of the institutional protocol at the primary study site.
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 |
|---|---|---|
| Continuous low-tidal volume ventilation with using FiO2 of 0.21The continuous low-tidal volume ventilation with using FiO2 of 0.21 will be defined as the tidal volume of 3 mL/kg IBW (up to maximum 200 mL), 0.21 of FiO2, respiratory rate of 5 per minute, and PEEP 5 cm H20). A recruitment maneuver with 30 cm H2O for 10 seconds will be performed before starting the selected ventilation mode in all patients. During the sub-study extra blood samples will be drawn before and after CPB. | Other | Continuous low-tidal volume ventilation with using FiO2 of 0.21 |
| Continuous low tidal volume ventilation with using FiO2 of 1.0The continuous low-tidal volume ventilation with using FiO2 of 1.0 will be defined as the tidal volume of 3 mL/kg IBW (up to maximum 200 mL), 1.0 of FiO2, respiratory rate of 5 per minute, and PEEP 5 cm H20). A recruitment maneuver with 30 cm H2O for 10 seconds will be performed before starting the selected ventilation mode in all patients. During the sub-study extra blood samples will be drawn before and after CPB. | Other | Continuous low tidal volume ventilation with using FiO2 of 1.0 |
| Apnea During CPBThere will be no ventilation used. But, during the sub-study part of the Apnea CPB extra blood samples will be drawn before and after CPB. | Other | Apnea |
Primary outcome
Occurrence of Composite including STS 30 day Mortality and postoperative pulmonary complications
Time frame: Within 30 days of surgery
Composite including STS 30-day mortality and postoperative pulmonary complications defined a early respiratory failure defined as PaO2/FiO2 ratio<200 mmHg at any time within the first 24 hours of ICU admission, postoperative reintubation during the hospital stay, prolonged ventilation, pneumonia, pleural effusion requiring drainage, pneumothorax requiring intervention, and readmission due to: pleural effusion requiring intervention, or pneumonia.
10 secondary outcomes
CPB time
Time frame: During surgery
ICU LOS
Time frame: Within 30 days of surgery
Early respiratory failure - PaO2/FiO2 ratio < 200 mmHg at any time within the first 24 hours of ICU admission
Time frame: 24 hours
Hospital LOS
Time frame: Within 30 days of surgery
Reintubation
Time frame: Within 30 days of surgery
Need for tracheostomy
Time frame: Within 30 days of surgery
Pleural effusion requiring drainage
Time frame: Within 30 days of surgery
Pneumonia
Time frame: Within 30 days of surgery
Readmission
Time frame: within 30 days of surgery
30-day mortality
Time frame: Within 30 days of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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.
Marta Kelava, 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 Continuous low-tidal volume ventilation with using FiO2 of 0.21, Continuous low tidal volume ventilation with using FiO2 of 1.0 and Apnea During CPB in people with Cardiac Surgery, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Occurrence of Composite including STS 30 day Mortality and postoperative pulmonary complications (time frame: Within 30 days of surgery). 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 26 Oct 2026.