Mechanical VentilationNCT05946707
Effects of Oxygen Supply After Lung Isolation in Thoracic Surgery
A study testing restrictive oxygen supply and liberal oxygen supply in people with Mechanical Ventilation and Thoracic Surgery, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The goal of this randomized clinical trial is to compare a liberal versus restrictive oxygen supply (fraction of inspired oxygen, FiO2) strategy in patients scheduled for thoracic surgery requiring one-lung ventilation during lung isolation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Thoracic Surgery, One-Lung Ventilation
- What is being tested?
- restrictive oxygen supply and liberal oxygen supply
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteAustria
- Study dates
- 19 Jul 2023to 7 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male and female subjects ≥ 18 years
- Elective thoracic surgery requiring OLV
- American Society of Anesthesiologists physical status classification I-III
- Written informed consent
Who cannot join
- Emergency surgery
- Female subjects known to be pregnant
- Known participation in another interventional clinical trial
- Empyema evacuation or signs of pulmonary infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oxygen Supply on Hypoxic Pulmonary Vasoconstriction and Lung Collapse After Lung Isolation in Thoracic Surgery - a Prospective, Randomized Clinical Trial
The goal of this randomized clinical trial is to compare a liberal versus restrictive oxygen supply (fraction of inspired oxygen, FiO2) strategy in patients scheduled for thoracic surgery requiring one-lung ventilation during lung isolation. The primary and secondary outcome parameters are:
- oxygenation of the blood after 30 minutes of one-lung ventilation, assessed by PaO2/FiO2 ratio
- time to lung collapse after start of one-lung ventilation
Read more
Participants in the control goup will receive an oxygen content of 100% before lung isolation, which will be subsequently decreased to achieve normoxia or mild hyperoxia (PaO2 of 75-120 mmHg).
The intervention group will receive the previous, during two-lung ventilation set, oxygen content and after lung isolation oxygen supply will be increased to secure adequate oxygenation of the blood (PaO2 75-120 mmHg) during one-lung ventilation.
The investigators hypothesize, that a higher fraction of inspired oxygen may impede hypoxic pulmonary vasoconstriction of the collapsed lung and thus decrease overall oxygenation performance during one-lung ventilation. Secondary endpoint will be the time to lung collapse, as a lower fraction of inspired oxygen and thus a higher nitrogen content may impede lung collapse.
Read the detailed description
After anesthesia induction and securing the airway with a double lumen tracheal tube, the patient will be ventilated with pressure-controlled ventilation (PCV) and the following settings during two-lung ventilation (TLV): positive end-expiratory pressure of 5 cmH2O, peak pressure set to achieve a tidal volume of 6-8 ml/kg, respiratory rate set to achieve normocapnia, I:E ratio set to 1:1.5, FiO2 adjusted to achieve normoxia. After changing to lateral position, the patient will be randomized to one of the following group:
- Decremental FiO2 titration: FiO2 will be set to 1.0 five minutes before lung isolation and reduced consecutively during one-lung ventilation (OLV) according to paO2 measurement obtained from arterial blood gas samples to achieve normoxia (paO2 of 75-120 mmHg).
- Incremental FiO2 titration: FiO2 will be maintained to secure normoxia during the entire surgery. This means, that the previous FiO2 setting during two-lung ventilation will be continued and after OLV initiation the FiO2 has to be adjusted, to secure normoxia assessed by continuous SpO2 measurement (SpO2 of 92-96 %) and paO2 measurement obtained from arterial blood gas samples (paO2 of 75-120 mmHg).
During OLV the applied tidal volume will be reduced to 4-6 ml/kg by an appropriate adjustment of peak pressure, otherwise the ventilator settings will not be changed. After 30 minutes of OLV the intervention period ends and because in both groups oxygenation will be adjusted to achieve a PaO2 of 75-120 mmHg during OLV, the routine anesthetic regime of both groups will not differ in the further course of thoracic surgery.
- Being tested
- restrictive oxygen supply, liberal oxygen supply
- Keywords
- Oxygen supply, Hypoxic pulmonary vasoconstriction, Lung collapse, Flow-controlled Ventilation
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restrictive oxygen supplyDrug
Oxygen supply will be limited to guarantee normoxia at the beginning of OLV.
liberal oxygen supplyDrug
Oxygen supply will be maximized to 100% at the beginning of OLV
| Study group | Role | What they receive |
|---|---|---|
| high oxygen: decremental FiO2 titration | Active comparator | Five minutes before lung isolation fraction of inspired oxygen will be increased to 1.0, representing the standard procedure for one-lung ventilation. 10, 20 and 30 minutes after OLV initiation paO2 obtained from arterial blood gas analysis will be measured and FiO2 titrated to achieve a paO2 of 75-120 mmHg. Receives: Drug: liberal oxygen supply |
| low oxygen: incremental FiO2 titration | Experimental | Before lung isolation fraction of inspired oxygen will be maintained as previously set to guarantee normoxia (SpO2 >92%). During OLV SpO2 will be continuously monitored and FiO2 adjusted to keep SpO2 >92%. Additionally after 10, 20 and 30 minutes after OLV initiation paO2 obtained from arterial blood gas analysis will be measured and FiO2 more precisely titrated to achieve a paO2 of 75-120 mmHg. Receives: Drug: restrictive oxygen supply |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation of the blood
Oxygenation of the blood will be assessed by the paO2/FiO2 ratio and compared between groups.
Measured: Primary outcome timepoint is defined at 30 minutes after start of OLV
Secondary outcomes (2)
lung collapse
Time to complete lung collapse will be recorded and compared between groups.
Measured: Lung collapse will be assessed and recorded as no collapse, partial collapse or complete collapse at 10, 20, 30 and 60 minutes after start of one-lung ventilation.
postoperative pulmonary complication
Occurence of postoperative pulmonary complications will be assessed postoperatively
Measured: Follow-up will be completed after end of hospital stay or 30-days of hospital stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start19 Jul 2023
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- non-blinded, randomized, controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Spraider, MD, Principal investigator, Medical University of Innsbruck, Department of Anesthesiology and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946707
- Sponsor's protocol ID
- 1051/2023
- Status last verified
- May 2023
- First submitted
- 25 May 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oxygen Supply on Hypoxic Pulmonary Vasoconstriction and Lung Collapse After Lung Isolation in Thoracic Surgery - a Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05946707
- Acronym / sponsor ID
- 1051/2023
- Keywords
- Oxygen supply, Hypoxic pulmonary vasoconstriction, Lung collapse, Flow-controlled Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 14 Jul 2023 (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.
The goal of this randomized clinical trial is to compare a liberal versus restrictive oxygen supply (fraction of inspired oxygen, FiO2) strategy in patients scheduled for thoracic surgery requiring one-lung ventilation during lung isolation. The primary and secondary outcome parameters are:
- oxygenation of the blood after 30 minutes of one-lung ventilation, assessed by PaO2/FiO2 ratio
- time to lung collapse after start of one-lung ventilation
Participants in the control goup will receive an oxygen content of 100% before lung isolation, which will be subsequently decreased to achieve normoxia or mild hyperoxia (PaO2 of 75-120 mmHg).
The intervention group will receive the previous, during two-lung ventilation set, oxygen content and after lung isolation oxygen supply will be increased to secure adequate oxygenation of the blood (PaO2 75-120 mmHg) during one-lung ventilation.
The investigators hypothesize, that a higher fraction of inspired oxygen may impede hypoxic pulmonary vasoconstriction of the collapsed lung and thus decrease overall oxygenation performance during one-lung ventilation. Secondary endpoint will be the time to lung collapse, as a lower fraction of inspired oxygen and thus a higher nitrogen content may impede lung collapse.
Detailed description
After anesthesia induction and securing the airway with a double lumen tracheal tube, the patient will be ventilated with pressure-controlled ventilation (PCV) and the following settings during two-lung ventilation (TLV): positive end-expiratory pressure of 5 cmH2O, peak pressure set to achieve a tidal volume of 6-8 ml/kg, respiratory rate set to achieve normocapnia, I:E ratio set to 1:1.5, FiO2 adjusted to achieve normoxia. After changing to lateral position, the patient will be randomized to one of the following group:
- Decremental FiO2 titration: FiO2 will be set to 1.0 five minutes before lung isolation and reduced consecutively during one-lung ventilation (OLV) according to paO2 measurement obtained from arterial blood gas samples to achieve normoxia (paO2 of 75-120 mmHg).
- Incremental FiO2 titration: FiO2 will be maintained to secure normoxia during the entire surgery. This means, that the previous FiO2 setting during two-lung ventilation will be continued and after OLV initiation the FiO2 has to be adjusted, to secure normoxia assessed by continuous SpO2 measurement (SpO2 of 92-96 %) and paO2 measurement obtained from arterial blood gas samples (paO2 of 75-120 mmHg).
During OLV the applied tidal volume will be reduced to 4-6 ml/kg by an appropriate adjustment of peak pressure, otherwise the ventilator settings will not be changed. After 30 minutes of OLV the intervention period ends and because in both groups oxygenation will be adjusted to achieve a PaO2 of 75-120 mmHg during OLV, the routine anesthetic regime of both groups will not differ in the further course of thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- non-blinded, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| high oxygen: decremental FiO2 titration | Active comparator | Drug: liberal oxygen supplyFive minutes before lung isolation fraction of inspired oxygen will be increased to 1.0, representing the standard procedure for one-lung ventilation. 10, 20 and 30 minutes after OLV initiation paO2 obtained from arterial blood gas analysis will be measured and FiO2 titrated to achieve a paO2 of 75-120 mmHg. |
| low oxygen: incremental FiO2 titration | Experimental | Drug: restrictive oxygen supplyBefore lung isolation fraction of inspired oxygen will be maintained as previously set to guarantee normoxia (SpO2 >92%). During OLV SpO2 will be continuously monitored and FiO2 adjusted to keep SpO2 >92%. Additionally after 10, 20 and 30 minutes after OLV initiation paO2 obtained from arterial blood gas analysis will be measured and FiO2 more precisely titrated to achieve a paO2 of 75-120 mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects ≥ 18 years
- Elective thoracic surgery requiring OLV
- American Society of Anesthesiologists physical status classification I-III
- Written informed consent
Key exclusion criteria (4 listed)
- Emergency surgery
- Female subjects known to be pregnant
- Known participation in another interventional clinical trial
- Empyema evacuation or signs of pulmonary infection
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 |
|---|---|---|
| restrictive oxygen supplyOxygen supply will be limited to guarantee normoxia at the beginning of OLV. | Drug | low oxygen: incremental FiO2 titration |
| liberal oxygen supplyOxygen supply will be maximized to 100% at the beginning of OLV | Drug | high oxygen: decremental FiO2 titration |
Primary outcome
oxygenation of the blood
Time frame: Primary outcome timepoint is defined at 30 minutes after start of OLV
Oxygenation of the blood will be assessed by the paO2/FiO2 ratio and compared between groups.
2 secondary outcomes
lung collapse
Time frame: Lung collapse will be assessed and recorded as no collapse, partial collapse or complete collapse at 10, 20, 30 and 60 minutes after start of one-lung ventilation.
postoperative pulmonary complication
Time frame: Follow-up will be completed after end of hospital stay or 30-days of hospital stay.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Mechanical Ventilation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingObservational study
DIAPHRAGM STRENGTH AND LUNG VOLUMES
Mechanical Ventilation
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Active, not recruitingObservational study
Potential Impact of the Use of the Application VentilO
Mechanical Ventilation Complication
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.
Patrick Spraider, MD principal investigator
Medical University of Innsbruck, Department of Anesthesiology and Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing restrictive oxygen supply and liberal oxygen supply in people with Mechanical Ventilation and Thoracic Surgery, run by Medical University Innsbruck at 1 site in Austria.
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 4 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: finished, as of the sponsor's last update on 12 Mar 2024. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
oxygenation of the blood (time frame: Primary outcome timepoint is defined at 30 minutes after start of OLV). 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 12 Mar 2024.