COPD, One Lung VentilationNCT02185430
Effects of Dexmedetomidine on Respiratory Mechanics and Oxygenation During One Lung Ventilation With Chronic Obstructive Lung Disease
A study testing saline infusion and dexmedetomidine infusion in people with COPD, One Lung Ventilation, run by Yonsei University.
Trial summary
COPD is often associated with the airflow limitation and the pulmonary hyperinflation. During the one-lung ventilation (OLV), COPD patients' physiologic dead space increases and hypercapnia may develop. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD, One Lung Ventilation
- What is being tested?
- saline infusion and dexmedetomidine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Apr 2015
- 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
- Above 40 years of age
- American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- COPD diagnosed , criteria ( on preop. PFT : FEV1 < 80%, FEV1 / FVC < 70% after bronchodilator)
- thoracic surgical procedure
Who cannot join
- severe functional liver or kidney disease
- diagnosed HF ( NYHA class >3)
- arrhythmia or received treatment with antiarrythmic drug .
- exceed BMI > 30 kg/ m2
- bradycardia (HR <50 bpm)
About this study
COPD is often associated with the airflow limitation and the pulmonary hyperinflation. During the one-lung ventilation (OLV), COPD patients' physiologic dead space increases and hypercapnia may develop. In addition, an alveolar overdistention by the pulmonary hyperinflation would divert pulmonary blood flow and impair arterial oxygenation. Dexmedetomidine has both vasoconstricting and vasodilatatory effects on a peripheral vasculature and a smooth muscle but its effects on bronchial smooth muscle is unknown. The investigators will evaluate the effects of dexmedetomidine (bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation) as bronchodilator in COPD patients when administered during surgery with the one lung ventilation. If result successfully shows the effect of dexmedetomidine as a predominantly a vasodilator on bronchial tree, the investigators study can support the dexmedetomidine as a vasodilator for pulmonary vessels and bronchial smooth muscle and as an excellent adjunct to anesthetic agents in COPD patients during the OLV.
- Conditions
- COPD, One Lung Ventilation
- Being tested
- saline infusion, dexmedetomidine infusion
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saline infusionDrug
saline infusion, bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation, intravenous
dexmedetomidine infusionDrug
dexmedetomidine, bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation, intravenous
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | saline solution Receives: Drug: saline infusion |
| dexmedetomidine group | Active comparator | dexmedetomidine Receives: Drug: dexmedetomidine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the oxygenation
PaO2/FiO2 ratio
Measured: At two-lung ventilation (T1) , 20 min after of one-lung ventilation (T2), 30 mins after Dex or placebo saline infusion (T3), 60 mins after Dex or placebo saline infusion (T4), at the termination of surgery in TLV (T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2015
- Study completionApr 2015
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 COPD, One Lung VentilationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Jun Oh, MD,PhD, Principal investigator, Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185430
- Sponsor's protocol ID
- 4-2014-0306
- Status last verified
- Oct 2015
- First submitted
- 3 Jul 2014
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee SH, Kim N, Lee CY, Ban MG, Oh YJ. Effects of dexmedetomidine on oxygenation and lung mechanics in patients with moderate chronic obstructive pulmonary disease undergoing lung cancer surgery: A randomised double-blinded trial. Eur J Anaesthesiol. 2016 Apr;33(4):275-82. doi: 10.1097/EJA.0000000000000405.
PubMed 26716866
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine on Respiratory Mechanics and Oxygenation During One Lung Ventilation With Chronic Obstructive Lung Disease
- ClinicalTrials.gov ID
- NCT02185430
- Acronym / sponsor ID
- 4-2014-0306
- Conditions
- COPD, One Lung Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Jul 2014 (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.
COPD is often associated with the airflow limitation and the pulmonary hyperinflation. During the one-lung ventilation (OLV), COPD patients' physiologic dead space increases and hypercapnia may develop. In addition, an alveolar overdistention by the pulmonary hyperinflation would divert pulmonary blood flow and impair arterial oxygenation. Dexmedetomidine has both vasoconstricting and vasodilatatory effects on a peripheral vasculature and a smooth muscle but its effects on bronchial smooth muscle is unknown. The investigators will evaluate the effects of dexmedetomidine (bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation) as bronchodilator in COPD patients when administered during surgery with the one lung ventilation. If result successfully shows the effect of dexmedetomidine as a predominantly a vasodilator on bronchial tree, the investigators study can support the dexmedetomidine as a vasodilator for pulmonary vessels and bronchial smooth muscle and as an excellent adjunct to anesthetic agents in COPD patients during the OLV.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: saline infusionsaline solution |
| dexmedetomidine group | Active comparator | Drug: dexmedetomidine infusiondexmedetomidine |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Above 40 years of age
- American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- COPD diagnosed , criteria ( on preop. PFT : FEV1 < 80%, FEV1 / FVC < 70% after bronchodilator)
- thoracic surgical procedure
Key exclusion criteria (5 listed)
- severe functional liver or kidney disease
- diagnosed HF ( NYHA class >3)
- arrhythmia or received treatment with antiarrythmic drug .
- exceed BMI > 30 kg/ m2
- bradycardia (HR <50 bpm)
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 |
|---|---|---|
| saline infusionsaline infusion, bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation, intravenous | Drug | Control group |
| dexmedetomidine infusiondexmedetomidine, bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation, intravenous | Drug | dexmedetomidine group |
Primary outcome
The change of the oxygenation
Time frame: At two-lung ventilation (T1) , 20 min after of one-lung ventilation (T2), 30 mins after Dex or placebo saline infusion (T3), 60 mins after Dex or placebo saline infusion (T4), at the termination of surgery in TLV (T5)
PaO2/FiO2 ratio
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 14 Oct 2015.
- Derived from this study: PubMed 26716866Lee SH, Kim N, Lee CY, Ban MG, Oh YJ. Effects of dexmedetomidine on oxygenation and lung mechanics in patients with moderate chronic obstructive pulmonary disease undergoing lung cancer surgery: A randomised double-blinded trial. Eur J Anaesthesiol. 2016 Apr;33(4):275-82. doi: 10.1097/EJA.0000000000000405.
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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, MD,PhD principal investigator
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing saline infusion and dexmedetomidine infusion in people with COPD, One Lung Ventilation, run by Yonsei University.
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 5 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 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The change of the oxygenation (time frame: At two-lung ventilation (T1) , 20 min after of one-lung ventilation (T2), 30 mins after Dex or placebo saline infusion (T3), 60 mins after Dex or placebo saline infusion (T4), at the termination of surgery in TLV (T5)). 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 NCT02185430, 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 14 Oct 2015.