Lung CancerNCT03794414
Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation
A study testing PEEP challenge in people with Lung Cancer and Lung Diseases, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The present study is to evaluate the effect of positive end-expiratory pressure (PEEP) in predicting fluid responsiveness in patients undergoing one-lung ventilation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer, Lung Diseases
- What is being tested?
- PEEP challenge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jan 2019to 26 Jun 2020
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing lung surgery under one-lung ventilation
Who cannot join
- arrhythmia
- moderate to severe valvular heart disease moderate to severe pericardial effusion left ventricular ejection fraction < 40%
- moderate to severe chronic obstructive lung disease
- unable to insert oesophageal Doppler Monitor (ODM) probe ( esophageal stent, esophageal cancer, previous esophageal surgery, esophageal stricture, esophageal varices, pharyngeal pouch and severe coagulopathy )
- patient refusal
- cannot understand the protocol
- less than 50kg or over 100kg in weight
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation
The present study is to evaluate the effect of positive end-expiratory pressure (PEEP) in predicting fluid responsiveness in patients undergoing one-lung ventilation.
Read the detailed description
Appropriate fluid challenge is crucial during lung surgery under one-lung ventilation. Applying PEEP in mechanically ventilating patients changes dynamic hemodynamic parameters (stroke volume variation, pulse pressure variation), which is more pronounced in hypovolemic patients. The aim of the present study is to evaluate the mechanically ventilating patients under one-lung ventilation requiring fluid resuscitation by applying PEEP to predict fluid responsiveness.
The investigators hypothesized that applying PEEP in one-lung ventilating patients can also change dynamic parameters and the magnitude of the change of stroke volume variation, pulse pressure variation can predict fluid responsiveness. The investigator applied PEEP 10 mmHg in one-lung ventilating patients and observed the dynamic parameters including stroke volume variation, pulse pressure variation and then infused 6ml/kg of crystalloid for fluid challenge and diagnosed fluid responsiveness as 10% increase of stroke volume after fluid challenge.
- Conditions
- Lung Cancer, Lung Diseases
- Being tested
- PEEP challenge
- Medical subject headings
- Lung Neoplasms, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP challengeProcedure or surgery
apply PEEP 10 mmHg in one-lung ventilating patients.
| Study group | Role | What they receive |
|---|---|---|
| fluid responder | Experimental | patients with 10% or more increase in stroke volume after fluid challenge. Both arms receive PEEP challenge. Receives: Procedure: PEEP challenge |
| fluid non-responder | Experimental | patients with no increase or less than 10% increase in stroke volume after fluid challenge. Both arms receive PEEP challenge Receives: Procedure: PEEP challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulse pressure variation
Temporary increase of PEEP will be able to predict fluid responsiveness using increase of pulse pressure variation over 1%.
Measured: 5 minutes after PEEP challenge
Secondary outcomes (1)
stroke volume variation
Temporary increase of PEEP will be able to predict fluid responsiveness using increase of stroke volume variation over 1%.
Measured: 5 minutes after PEEP challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start31 Jan 2019
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Choi Eun MI, Hallym University Kangnam Sacred Heart Hospital
- Investigators
- Eun-mi Choi, Professor, Study chair, Kangnam Sungshim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794414
- Sponsor's protocol ID
- 2018-11-028
- Status last verified
- Jul 2020
- First submitted
- 3 Jan 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: However, I can always share if required.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation
- ClinicalTrials.gov ID
- NCT03794414
- Acronym / sponsor ID
- 2018-11-028
- Conditions
- Lung Cancer, Lung Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 7 Jan 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.
The present study is to evaluate the effect of positive end-expiratory pressure (PEEP) in predicting fluid responsiveness in patients undergoing one-lung ventilation.
Detailed description
Appropriate fluid challenge is crucial during lung surgery under one-lung ventilation. Applying PEEP in mechanically ventilating patients changes dynamic hemodynamic parameters (stroke volume variation, pulse pressure variation), which is more pronounced in hypovolemic patients. The aim of the present study is to evaluate the mechanically ventilating patients under one-lung ventilation requiring fluid resuscitation by applying PEEP to predict fluid responsiveness.
The investigators hypothesized that applying PEEP in one-lung ventilating patients can also change dynamic parameters and the magnitude of the change of stroke volume variation, pulse pressure variation can predict fluid responsiveness. The investigator applied PEEP 10 mmHg in one-lung ventilating patients and observed the dynamic parameters including stroke volume variation, pulse pressure variation and then infused 6ml/kg of crystalloid for fluid challenge and diagnosed fluid responsiveness as 10% increase of stroke volume after fluid challenge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluid responder | Experimental | Procedure: PEEP challengepatients with 10% or more increase in stroke volume after fluid challenge. Both arms receive PEEP challenge. |
| fluid non-responder | Experimental | Procedure: PEEP challengepatients with no increase or less than 10% increase in stroke volume after fluid challenge. Both arms receive PEEP challenge |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing lung surgery under one-lung ventilation
Key exclusion criteria (7 listed)
- arrhythmia
- moderate to severe valvular heart disease moderate to severe pericardial effusion left ventricular ejection fraction < 40%
- moderate to severe chronic obstructive lung disease
- unable to insert oesophageal Doppler Monitor (ODM) probe ( esophageal stent, esophageal cancer, previous esophageal surgery, esophageal stricture, esophageal varices, pharyngeal pouch and severe coagulopathy )
- patient refusal
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 |
|---|---|---|
| PEEP challengeapply PEEP 10 mmHg in one-lung ventilating patients. | Procedure or surgery | fluid non-responder, fluid responder |
Primary outcome
pulse pressure variation
Time frame: 5 minutes after PEEP challenge
Temporary increase of PEEP will be able to predict fluid responsiveness using increase of pulse pressure variation over 1%.
1 secondary outcome
stroke volume variation
Time frame: 5 minutes after PEEP challenge
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 29 Jul 2020.
- Individual participant dataSharing planned: No. However, I can always share if required.
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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.
Eun-mi Choi, Professor study chair
Kangnam Sungshim Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP challenge in people with Lung Cancer and Lung Diseases, run by Hallym University Kangnam Sacred Heart 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 1 inclusion and 7 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 29 Jul 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?
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?
pulse pressure variation (time frame: 5 minutes after PEEP challenge). 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 29 Jul 2020.