Lung CancerNCT01636973
Effects of Humidified Ventilation on Arterial Oxygenation and Respiratory Mechanics During One Lung Ventilation
A study testing Vaporizing humidifier in people with Lung Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
A continuous loss of moisture and heat occurs during mechanical ventilation and prediposes patients to airway damage. Vaporizing humidifier has known to be advantages of improvement of oxygenation and protection of airway damage. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Vaporizing humidifier
- 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
- Mar 2011to Apr 2012
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status class I,II
- Unilateral lung lobectomy
- Use of one-lung ventilation
Who cannot join
- COPD
- CAOD
- Unstable cardiovascular status
- Peak inspiratory pressure > 30 mmHg
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 120-752
About this study
A continuous loss of moisture and heat occurs during mechanical ventilation and prediposes patients to airway damage. Vaporizing humidifier has known to be advantages of improvement of oxygenation and protection of airway damage. However, there is a lack of study about the effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung ventilation. We therefore invesgate that the effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung ventilation .
- Conditions
- Lung Cancer
- Being tested
- Vaporizing humidifier
- Keywords
- Lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaporizing humidifierProcedure or surgery
Vaporizing humidifier applying during one-lung ventilation
| Study group | Role | What they receive |
|---|---|---|
| Vaporizing humidifier | Experimental | Vaporizing humidifier applying during one-lung ventilation Receives: Procedure: Vaporizing humidifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial oxygenation
T1,T2,T3,T4: all measurement in lateral position, T1-arterial oxygenation(PaO2), T2-arterial oxygenation(PaO2),T3-arterial oxygenation(PaO2),T4-arterial oxygenation(PaO2)
Measured: T1(10min before one-lung ventilation),T2(30min after one-lung ventilation),T3(60min), T4(10min after two lung ventilation)
Secondary outcomes (1)
Respiratory dynamic parameters
T1,T2,T3,T4: T1-respiratory dynamic parameters, T2-respiratory dynamic parameters, T3-respiratory dynamic parameters, T4-respiratory dynamic parameters
Measured: T1,T2,T3,T4 (same as 'primary outcome measure')
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Jun Oh, M.D.,PhD., Study chair, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636973
- Sponsor's protocol ID
- 1-2011-0027
- Status last verified
- Jul 2012
- First submitted
- 5 Jul 2012
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Humidified Ventilation on Arterial Oxygenation and Respiratory Mechanics During One Lung Ventilation
- ClinicalTrials.gov ID
- NCT01636973
- Acronym / sponsor ID
- 1-2011-0027
- Conditions
- Lung Cancer
- Keywords
- Lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Jul 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.
A continuous loss of moisture and heat occurs during mechanical ventilation and prediposes patients to airway damage. Vaporizing humidifier has known to be advantages of improvement of oxygenation and protection of airway damage. However, there is a lack of study about the effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung ventilation. We therefore invesgate that the effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung ventilation .
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaporizing humidifier | Experimental | Procedure: Vaporizing humidifierVaporizing humidifier applying during one-lung ventilation |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status class I,II
- Unilateral lung lobectomy
- Use of one-lung ventilation
Key exclusion criteria (4 listed)
- COPD
- CAOD
- Unstable cardiovascular status
- Peak inspiratory pressure > 30 mmHg
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 |
|---|---|---|
| Vaporizing humidifierVaporizing humidifier applying during one-lung ventilation | Procedure or surgery | Vaporizing humidifier |
Primary outcome
arterial oxygenation
Time frame: T1(10min before one-lung ventilation),T2(30min after one-lung ventilation),T3(60min), T4(10min after two lung ventilation)
T1,T2,T3,T4: all measurement in lateral position, T1-arterial oxygenation(PaO2), T2-arterial oxygenation(PaO2),T3-arterial oxygenation(PaO2),T4-arterial oxygenation(PaO2)
1 secondary outcome
Respiratory dynamic parameters
Time frame: T1,T2,T3,T4 (same as 'primary outcome measure')
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 10 Jul 2012.
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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.
Young Jun Oh, M.D.,PhD. study chair
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaporizing humidifier in people with Lung Cancer, 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 3 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 10 Jul 2012. 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?
arterial oxygenation (time frame: T1(10min before one-lung ventilation),T2(30min after one-lung ventilation),T3(60min), T4(10min after two lung ventilation)). 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 10 Jul 2012.