Lung CancerNCT04007354
Inflammatory Response After One-lung Ventilation According to Ventilation Methods
A study testing Ventilation method in people with Lung Cancer, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
Unlike conventional thoracic surgery performed under general anesthesia with tracheal intubation, non-intubated thoracic surgery with sedation and regional anesthesia has been performed recently. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Ventilation method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jun 2018to 20 May 2019
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective video-assisted thoracoscopic surgery (VATS) lobectomy
- 20 < age < 75
- American Society of Anesthesiologists (ASA) classification I~II
Who cannot join
- preoperative inflammation (CRP>10ng/㎖, WBC>10,000/mm3, body temperature >38℃)
- steroid administration within 1 month
- hematologic / autoimmune disease
- congestive heart failure (NYHA class III~IV) or significant arrhythmia
- severe obstructive / restrictive pulmonary disease
- previous history of thoracic surgery
- BMI >28kg/m2
- expected difficult airway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Inflammatory Response After One-lung Ventilation With Positive Ventilation and Self-respiration
Unlike conventional thoracic surgery performed under general anesthesia with tracheal intubation, non-intubated thoracic surgery with sedation and regional anesthesia has been performed recently. Non-intubated thoracic surgery is expected to reduce the postoperative inflammatory changes by maintaining more physiologic status during the operation compared to intubated thoracic surgery. The aim of this study was to compare perioperative immunological changes between intubated and non-intubated thoracic surgery.
- Conditions
- Lung Cancer
- Being tested
- Ventilation method
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation methodOther
Depending on the group assignment, mechanical ventilation or spontaneous breathing was performed.
| Study group | Role | What they receive |
|---|---|---|
| Intubated | No intervention | The patient was intubated with a left-sided double-lumen endobronchial tube. The protective ventilation was performed as follows: a tidal volume of 6 mL/kg predicted body weight, I:E ratio of 1:2, a respiratory rate to maintain PaCO2 within 35 to 45 mmHg, and positive end-expiratory pressure at 5 cmH2O. If the airway pressure exceeded 25 cmH2O, tidal volume was adjusted. |
| Non-intubated | Experimental | The patients were oxygenated via facial mask with O2 5~10 L/min during the whole procedure. The end-tidal carbon dioxide (EtCO2) was measured by insertion of a detector inside one of the nostrils. Respiration rate was maintained between 12 and 20 breaths/min with adjustment of anesthetics. Receives: Other: Ventilation method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin (IL)-6
Blood samples collected from the antecubital vein
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start25 Jun 2018
- Primary completion19 Apr 2019
- Study completion20 May 2019
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 Lung CancerStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Catholic University of Korea
- Responsible party
- Principal investigator, Wonjung Hwang, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007354
- Sponsor's protocol ID
- KC17EESI0558
- Status last verified
- Jun 2019
- First submitted
- 1 Jul 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jeon J, Sung S, Moon Y, Koo J, Hyun K, Han K, Hwang W. Comparison of early postoperative cytokine changes in patients undergoing intubated and non-intubated thoracic surgery: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2021 Apr 8;32(3):343-350. doi: 10.1093/icvts/ivaa265.
PubMed 33831216
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Inflammatory Response After One-lung Ventilation With Positive Ventilation and Self-respiration
- ClinicalTrials.gov ID
- NCT04007354
- Acronym / sponsor ID
- KC17EESI0558
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- The Catholic University of Korea
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 5 Jul 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.
Unlike conventional thoracic surgery performed under general anesthesia with tracheal intubation, non-intubated thoracic surgery with sedation and regional anesthesia has been performed recently. Non-intubated thoracic surgery is expected to reduce the postoperative inflammatory changes by maintaining more physiologic status during the operation compared to intubated thoracic surgery. The aim of this study was to compare perioperative immunological changes between intubated and non-intubated thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubated | No intervention | –The patient was intubated with a left-sided double-lumen endobronchial tube. The protective ventilation was performed as follows: a tidal volume of 6 mL/kg predicted body weight, I:E ratio of 1:2, a respiratory rate to maintain PaCO2 within 35 to 45 mmHg, and positive end-expiratory pressure at 5 cmH2O. If the airway pressure exceeded 25 cmH2O, tidal volume was adjusted. |
| Non-intubated | Experimental | Other: Ventilation methodThe patients were oxygenated via facial mask with O2 5~10 L/min during the whole procedure. The end-tidal carbon dioxide (EtCO2) was measured by insertion of a detector inside one of the nostrils. Respiration rate was maintained between 12 and 20 breaths/min with adjustment of anesthetics. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective video-assisted thoracoscopic surgery (VATS) lobectomy
- 20 < age < 75
- American Society of Anesthesiologists (ASA) classification I~II
Key exclusion criteria (8 listed)
- preoperative inflammation (CRP>10ng/㎖, WBC>10,000/mm3, body temperature >38℃)
- steroid administration within 1 month
- hematologic / autoimmune disease
- congestive heart failure (NYHA class III~IV) or significant arrhythmia
- severe obstructive / restrictive pulmonary disease
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 |
|---|---|---|
| Ventilation methodDepending on the group assignment, mechanical ventilation or spontaneous breathing was performed. | Other | Non-intubated |
Primary outcome
Interleukin (IL)-6
Time frame: 24 hours after surgery
Blood samples collected from the antecubital vein
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 5 Jul 2019.
- Derived from this study: PubMed 33831216Jeon J, Sung S, Moon Y, Koo J, Hyun K, Han K, Hwang W. Comparison of early postoperative cytokine changes in patients undergoing intubated and non-intubated thoracic surgery: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2021 Apr 8;32(3):343-350. doi: 10.1093/icvts/ivaa265.
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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 Ventilation method in people with Lung Cancer, run by Seoul St. Mary's Hospital 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 3 inclusion and 8 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 5 Jul 2019. 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?
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?
Interleukin (IL)-6 (time frame: 24 hours after surgery). 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 NCT04007354, 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 5 Jul 2019.