Mechanical Ventilation ComplicationNCT01630395
The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery
A study testing protective ventilation and Recruitment maneuver combined with protective ventilation in people with Mechanical Ventilation Complication and Thoracic Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine if a recruitment maneuver combined with protective ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to one-lung ventilation during thoracic surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Mechanical Ventilation Complication, Thoracic Surgery, Inflammation
- What is being tested?
- protective ventilation and Recruitment maneuver combined with protective ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to May 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 Years and older
- Patients undergoing thoracic surgery
Who cannot join
- Emergency surgery
- Heart failure
- Pulmonary hypertension
- Forced vital capacity or forced expiratory volume in 1 sec < 50% of the predicted values
- Coagulation disorder
- Pulmonary or extrapulmonary infections
Show all 9Show fewer
- History of treatment with steroid in 3 months before surgery
- History of recurrent pneumothorax
- History of lung resection surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Recruitment Maneuver With Protective Ventilation on the Pulmonary and Systemic Inflammatory Response to One-lung Ventilation
The purpose of this study is to determine if a recruitment maneuver combined with protective ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to one-lung ventilation during thoracic surgery.
- Being tested
- protective ventilation, Recruitment maneuver combined with protective ventilation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protective ventilationProcedure or surgery
low tidal volume and PEEP
Recruitment maneuver combined with protective ventilationProcedure or surgery
Low tidal volume, PEEP and recruitment maneuver
| Study group | Role | What they receive |
|---|---|---|
| conventional | No intervention | Two-lung ventilation: tidal volume = 10 ml/kg, no PEEP. One-lung ventilation: tidal volume = 10 ml/kg, no PEEP |
| Protective | Active comparator | Two-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O. Receives: Procedure: protective ventilation |
| Recruitment | Active comparator | Two-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O. Recruitment maneuver will be applied during one-lung ventilation. Receives: Procedure: Recruitment maneuver combined with protective ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of IL-8, TNFa in the bronchoalveolar lavage
Measured: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
Secondary outcomes (4)
Levels of IL-1, IL-6, IL-10 in the bronchoalveolar lavage
Measured: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa
Measured: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
oxygenation
Changes in PaO2/FIO2 ratio
Measured: 1 hour after extubation
Chest-X ray
Measured: 7 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 posted28 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630395
- Sponsor's protocol ID
- JHBahk_recruitment maneuver
- Status last verified
- Jun 2012
- First submitted
- 21 Jun 2012
- Last updated
- 21 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Recruitment Maneuver With Protective Ventilation on the Pulmonary and Systemic Inflammatory Response to One-lung Ventilation
- ClinicalTrials.gov ID
- NCT01630395
- Acronym / sponsor ID
- JHBahk_recruitment maneuver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Jun 2012 (estimated)
- 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 purpose of this study is to determine if a recruitment maneuver combined with protective ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to one-lung ventilation during thoracic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional | No intervention | –Two-lung ventilation: tidal volume = 10 ml/kg, no PEEP. One-lung ventilation: tidal volume = 10 ml/kg, no PEEP |
| Protective | Active comparator | Procedure: protective ventilationTwo-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O. |
| Recruitment | Active comparator | Procedure: Recruitment maneuver combined with protective ventilationTwo-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O. Recruitment maneuver will be applied during one-lung ventilation. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20 Years and older
- Patients undergoing thoracic surgery
Key exclusion criteria (9 listed)
- Emergency surgery
- Heart failure
- Pulmonary hypertension
- Forced vital capacity or forced expiratory volume in 1 sec < 50% of the predicted values
- Coagulation disorder
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 |
|---|---|---|
| protective ventilationlow tidal volume and PEEP | Procedure or surgery | Protective |
| Recruitment maneuver combined with protective ventilationLow tidal volume, PEEP and recruitment maneuver | Procedure or surgery | Recruitment |
Primary outcome
Levels of IL-8, TNFa in the bronchoalveolar lavage
Time frame: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
4 secondary outcomes
Levels of IL-1, IL-6, IL-10 in the bronchoalveolar lavage
Time frame: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa
Time frame: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery
oxygenation
Time frame: 1 hour after extubation
Chest-X ray
Time frame: 7 days after surgery
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 21 Apr 2016.
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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 protective ventilation and Recruitment maneuver combined with protective ventilation in people with Mechanical Ventilation Complication and Thoracic Surgery, run by Seoul National University 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 2 inclusion and 9 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 21 Apr 2016. 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?
Levels of IL-8, TNFa in the bronchoalveolar lavage (time frame: up to 20 minutes, after reexpansion of the non-dependent lung at the end 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 21 Apr 2016.