Thoracic SurgeryNCT04175379
The Effect of Permissive Hypercapnia on Oxygenation and Post-operative Pulmonary Complication During One-lung Ventilation
A study testing group 40, group 50 and group 60 in people with Thoracic Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Permissive hypercapnia increased the survival rate in patients with acute respiratory distress syndrome (ARDS) who required mechanical ventilation in critical care medicine. This has been explained by its association with ventilator induced lung injury. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- group 40, group 50 and group 60
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Nov 2019to Oct 2021
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients aged 40-80 years who are planning to have thoracoscopic single lobectomy or segmentectomy with one lung ventilation during surgery.
- American Society of Anesthesiologists (ASA) classification 1~3
Who cannot join
- patients with heart failure (NYHA class III~IV)
- patients who are having moderate obstructive lung disease or restrictive lung disease
- Low DLCO (< 75%)
- patients with brain disease history or increased ICP
- patients with pulmonary hypertension (mean PAP>25mmHg)
- patients with liver disease (AST level ≥100 IU/mL or ALT ≥ level 50 IU/L) or kidney disease (Creatine level ≥ 1.5 mg/dL)
Show all 11Show fewer
- patients with pre-existing hypercapnia or metabolic acidosis
- body mass index (BMI) > 30 kg/m2
- patients who have had contralateral lung surgery
- patients who cannot read explanation and consent form
- patients who are pregnant
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 03722
About this study
Official title: The Effect of Permissive Hypercapnia on Oxygenation and Post-operative Pulmonary Complication During One-lung Ventilation : Prospective, Randomized Controlled Study
Permissive hypercapnia increased the survival rate in patients with acute respiratory distress syndrome (ARDS) who required mechanical ventilation in critical care medicine. This has been explained by its association with ventilator induced lung injury. Since then, a protective lung ventilation strategy has been very important, with a low tidal volume of 4-6 ml/kg. Patients undergoing surgery will inevitably require mechanical ventilation. In particular, patients undergoing one lung ventilation for thoracic surgery may have increased airway pressure and a greater chance of ventilator induced lung injury. Recently, protective lung ventilation has been applied to patients undergoing one ung ventilation during thoracic surgery. The purpose of this study is to evaluate the difference in the degree of pulmonary oxygenation and the incidence of postoperative pulmonary complications in hypercapnia induced by controlling the respiratory rate with a constant tidal volume.
- Conditions
- Thoracic Surgery
- Being tested
- group 40, group 50, group 60
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group 40Other
During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 40 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2).
group 50Other
During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 50 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2).
group 60Other
During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 60 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2).
| Study group | Role | What they receive |
|---|---|---|
| group 40 | Experimental | In group 40, target PaCO2 is 40 during surgery Receives: Other: group 40 |
| group 50 | Experimental | In group 50, target PaCO2 is 50 during surgery Receives: Other: group 50 |
| group 60 | Experimental | In group 60, target PaCO2 is 60 during surgery Receives: Other: group 60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 ratio
(arterial oxygen partial pressure / fractional inspired oxygen) at the time of T2 (PaO2 of ABGA/FiO2) T2
Measured: about 60 minutes after reaching to the target PaCO2 (T2)
Secondary outcomes (6)
Post-op complication: desaturation event
desaturation event (<90%) the first 3 days after surgery
Measured: first 3 days after surgery
Post-op complication: oxygen therapy
necessity of oxygen therapy within the first 2~7 days after surgery hospitalized days, ICU days, expire
Measured: first 2~7 days after surgery
Post-op complication
The presence or absence of post operative complication like pneumonia, acute lung injury, re-intubation, ICU admission, ventilator care, empyema, broncho-pleura fistula, air-leakage, pleural effusion, pulmonary embolism, tracheostomy, wound infection, AKI, MI, etc.
Measured: 30 days after surgery
Post-op complication: hospitalized days
length of hospitalized stays CU days, expire
Measured: 30 days after surgery
Post-op complication: ICU days
length of ICU stays
Measured: 30 days after surgery
Dead
patient has been dead or not
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start25 Nov 2019
- Primary completionAug 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Random sampling using random numbers is divided into three groups, and the ratio of each group is 1: 1: 1.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 279 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175379
- Sponsor's protocol ID
- 4-2019-0904
- Status last verified
- Dec 2019
- First submitted
- 15 Nov 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joe YE, Lee CY, Kim N, Lee K, Kang SJ, Oh YJ. Effect of permissive hypercarbia on lung oxygenation during one-lung ventilation and postoperative pulmonary complications in patients undergoing thoracic surgery: A prospective randomised controlled trial. Eur J Anaesthesiol. 2023 Sep 1;40(9):691-698. doi: 10.1097/EJA.0000000000001873. Epub 2023 Jul 15.
PubMed 37455644
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Permissive Hypercapnia on Oxygenation and Post-operative Pulmonary Complication During One-lung Ventilation : Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04175379
- Acronym / sponsor ID
- 4-2019-0904
- Conditions
- Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 279 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 25 Nov 2019 (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.
Permissive hypercapnia increased the survival rate in patients with acute respiratory distress syndrome (ARDS) who required mechanical ventilation in critical care medicine. This has been explained by its association with ventilator induced lung injury. Since then, a protective lung ventilation strategy has been very important, with a low tidal volume of 4-6 ml/kg. Patients undergoing surgery will inevitably require mechanical ventilation. In particular, patients undergoing one lung ventilation for thoracic surgery may have increased airway pressure and a greater chance of ventilator induced lung injury. Recently, protective lung ventilation has been applied to patients undergoing one ung ventilation during thoracic surgery. The purpose of this study is to evaluate the difference in the degree of pulmonary oxygenation and the incidence of postoperative pulmonary complications in hypercapnia induced by controlling the respiratory rate with a constant tidal volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Random sampling using random numbers is divided into three groups, and the ratio of each group is 1: 1: 1.
| Arm | Type | Receives |
|---|---|---|
| group 40 | Experimental | Other: group 40In group 40, target PaCO2 is 40 during surgery |
| group 50 | Experimental | Other: group 50In group 50, target PaCO2 is 50 during surgery |
| group 60 | Experimental | Other: group 60In group 60, target PaCO2 is 60 during surgery |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients aged 40-80 years who are planning to have thoracoscopic single lobectomy or segmentectomy with one lung ventilation during surgery.
- American Society of Anesthesiologists (ASA) classification 1~3
Key exclusion criteria (11 listed)
- patients with heart failure (NYHA class III~IV)
- patients who are having moderate obstructive lung disease or restrictive lung disease
- Low DLCO (< 75%)
- patients with brain disease history or increased ICP
- patients with pulmonary hypertension (mean PAP>25mmHg)
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 |
|---|---|---|
| group 40During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 40 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2). | Other | group 40 |
| group 50During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 50 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2). | Other | group 50 |
| group 60During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 60 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2). | Other | group 60 |
Primary outcome
PaO2/FiO2 ratio
Time frame: about 60 minutes after reaching to the target PaCO2 (T2)
(arterial oxygen partial pressure / fractional inspired oxygen) at the time of T2 (PaO2 of ABGA/FiO2) T2
6 secondary outcomes
Post-op complication: desaturation event
Time frame: first 3 days after surgery
Post-op complication: oxygen therapy
Time frame: first 2~7 days after surgery
Post-op complication
Time frame: 30 days after surgery
Post-op complication: hospitalized days
Time frame: 30 days after surgery
Post-op complication: ICU days
Time frame: 30 days after surgery
Dead
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Derived from this study: PubMed 37455644Joe YE, Lee CY, Kim N, Lee K, Kang SJ, Oh YJ. Effect of permissive hypercarbia on lung oxygenation during one-lung ventilation and postoperative pulmonary complications in patients undergoing thoracic surgery: A prospective randomised controlled trial. Eur J Anaesthesiol. 2023 Sep 1;40(9):691-698. doi: 10.1097/EJA.0000000000001873. Epub 2023 Jul 15.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group 40, group 50 and group 60 in people with Thoracic Surgery, run by Yonsei University at 1 site in South Korea.
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 11 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: status not confirmed, as of the sponsor's last update on 2 Jan 2020. 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 South Korea. 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?
Results are not available in the source record.
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?
PaO2/FiO2 ratio (time frame: about 60 minutes after reaching to the target PaCO2 (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04175379, which also lists 1 linked publication.
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 2 Jan 2020.