Patients Receiving Protective Lung VentilationNCT04118244
A Functional Test to Assess Fluid Status During Lung Protective Ventilation Strategies
An observational study of Patients Receiving Protective Lung Ventilation and Patients in Grey Zone (3 < Pulse Pressure Variation (PPV) < 17, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Dynamic preload indices, such as pulse pressure variation (PPV) and stroke volume variation (SVV) are generally accepted as accurate indicator of fluid responsiveness in mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Patients Receiving Protective Lung Ventilation, Patients in Grey Zone (3 < Pulse Pressure Variation (PPV) < 17
- What is being tested?
- lung recruitment maneuver
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Oct 2019to 31 Oct 2021
- Phase
- Observational
- 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
- Adult, Older adult
Study population: tertiary care center
Who may be able to join
- Adult patients receiving laparotomy and lung protective ventilation
Who cannot join
- preoperative arrhythmia
- Severe bradycardia
- Moderate to severe valvular disease
- left ventricular ejection fraction < 50%
- Poorly controlled hypertension (systolic BP > 160 mmHg)
- Patients with renal insufficiency (creatinine > 1.5 mg/dL)
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- Moderate to severe liver disease
- BMI >.30 or < 15 kg/ m2
- preexisting pulmonary disease
- FEV1 < 60% of predicted value
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kangnam Sacred Heart Hospital, Hallym University College of Medicine
Seoul
About this study
Official title: Development of a Functional Test to Assess Fluid Status During Lung Protective Ventilation Strategies in the Operating Room.
Dynamic preload indices, such as pulse pressure variation (PPV) and stroke volume variation (SVV) are generally accepted as accurate indicator of fluid responsiveness in mechanically ventilated patients. Because SVV and PPV are generated by the pressure transmitted from the airways to the pleural and pericardial spaces, their reliability is limited in patients receiving low tidal volume (VT) ventilation and in those with a driving pressure lower than 20 cm H2O.
Lung-protective ventilation using low VT with positive end expiratory pressure (PEEP) has recently been demonstrated to significantly improve postoperative outcome, and its application is gradually increasing in surgical patients. However, protective ventilation alters the predictability of dynamic preload indices and thus limits their use in the operating theatre.
Read more
Lung recruitment maneuvers (LRMs), used to reopen collapsed lung, and PEEP have been proposed as the key components of lung-protective ventilation strategy. LRM increases intrathoracic pressure, which in turn causes a transient decrease in stroke volume (SV) and arterial pressure; this may depend on preload status. Interestingly, recent study reported that the augmented PPV during LRM using vital capacity maneuver (VCM, continuous positive airway pressure of 30 cm H2O for 10 s) could predict preload responsiveness under open chest condition.
Investigators hypothesized that the augmented PPV and SVV by a stepwise LRM with incremental PEEP could represent a functional test to suggest preload responsiveness and, therefore, predict fluid responsiveness. The aims of the current study were (1) to assess the ability of augmented PPV and SVV during stepwise LRM-induced to predict fluid responsiveness in mechanically ventilated patients in the operating room, (2) to assess the ability of stepwise LRM-induced decrease in SV (ΔSV-LRM) to predict fluid responsiveness.
- Conditions
- Patients Receiving Protective Lung Ventilation, Patients in Grey Zone (3 < Pulse Pressure Variation (PPV) < 17
- Being tested
- lung recruitment maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung recruitment maneuverDiagnostic test
The ventilator was switched to pressure control ventilation, inspiratory time was increased to 50%, the peak inspiratory pressure gradient (above PEEP) was set at 15cm H2O, and PEEP was progressively increased to obtain a stepwise increase of peak inspiratory to 20, 25, and 30 cm H2O every three breaths. The final recruiting pressure of 30 cm H2O was applied for six breaths.
What is being measured
The primary outcome is the main question the study is designed to answer.
PPV_augmented
augmented pulse pressure variation by lung recruitment maneuver
Measured: During the last 5 second of lung recruitment maneuver
SVV_augmented
augmented stroke volume variation by lung recruitment maneuver
Measured: During the last 5 second of lung recruitment maneuver
Secondary outcomes (2)
ΔSV_LRM
The degree of reduction of stroke volume induced by lung recruitment maneuver
Measured: During the last 5 second of lung recruitment maneuver
ΔETCO2_LRM
The degree of reduction of end tidal CO2 concentration induced by lung recruitment maneuver
Measured: During the last 5 second of lung recruitment maneuver
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start7 Oct 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Receiving Protective Lung VentilationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun joohyun, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118244
- Sponsor's protocol ID
- 2019-07-004-002
- Status last verified
- Jan 2026
- First submitted
- 2 Oct 2019
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Functional Test to Assess Fluid Status During Lung Protective Ventilation Strategies in the Operating Room.
- ClinicalTrials.gov ID
- NCT04118244
- Acronym / sponsor ID
- 2019-07-004-002
- Conditions
- Patients Receiving Protective Lung Ventilation, Patients in Grey Zone (3 < Pulse Pressure Variation (PPV) < 17
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 8 Oct 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.
Dynamic preload indices, such as pulse pressure variation (PPV) and stroke volume variation (SVV) are generally accepted as accurate indicator of fluid responsiveness in mechanically ventilated patients. Because SVV and PPV are generated by the pressure transmitted from the airways to the pleural and pericardial spaces, their reliability is limited in patients receiving low tidal volume (VT) ventilation and in those with a driving pressure lower than 20 cm H2O.
Lung-protective ventilation using low VT with positive end expiratory pressure (PEEP) has recently been demonstrated to significantly improve postoperative outcome, and its application is gradually increasing in surgical patients. However, protective ventilation alters the predictability of dynamic preload indices and thus limits their use in the operating theatre.
Lung recruitment maneuvers (LRMs), used to reopen collapsed lung, and PEEP have been proposed as the key components of lung-protective ventilation strategy. LRM increases intrathoracic pressure, which in turn causes a transient decrease in stroke volume (SV) and arterial pressure; this may depend on preload status. Interestingly, recent study reported that the augmented PPV during LRM using vital capacity maneuver (VCM, continuous positive airway pressure of 30 cm H2O for 10 s) could predict preload responsiveness under open chest condition.
Investigators hypothesized that the augmented PPV and SVV by a stepwise LRM with incremental PEEP could represent a functional test to suggest preload responsiveness and, therefore, predict fluid responsiveness. The aims of the current study were (1) to assess the ability of augmented PPV and SVV during stepwise LRM-induced to predict fluid responsiveness in mechanically ventilated patients in the operating room, (2) to assess the ability of stepwise LRM-induced decrease in SV (ΔSV-LRM) to predict fluid responsiveness.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- tertiary care center
Key inclusion criteria (1 listed)
- Adult patients receiving laparotomy and lung protective ventilation
Key exclusion criteria (10 listed)
- preoperative arrhythmia
- Severe bradycardia
- Moderate to severe valvular disease
- left ventricular ejection fraction < 50%
- Poorly controlled hypertension (systolic BP > 160 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 |
|---|---|---|
| lung recruitment maneuverThe ventilator was switched to pressure control ventilation, inspiratory time was increased to 50%, the peak inspiratory pressure gradient (above PEEP) was set at 15cm H2O, and PEEP was progressively increased to obtain a stepwise increase of peak inspiratory to 20, 25, and 30 cm H2O every three breaths. The final recruiting pressure of 30 cm H2O was applied for six breaths. | Diagnostic test | – |
Primary outcome
PPV_augmented
Time frame: During the last 5 second of lung recruitment maneuver
augmented pulse pressure variation by lung recruitment maneuver
SVV_augmented
Time frame: During the last 5 second of lung recruitment maneuver
augmented stroke volume variation by lung recruitment maneuver
2 secondary outcomes
ΔSV_LRM
Time frame: During the last 5 second of lung recruitment maneuver
ΔETCO2_LRM
Time frame: During the last 5 second of lung recruitment maneuver
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 Jan 2026.
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?
An observational study of Patients Receiving Protective Lung Ventilation and Patients in Grey Zone (3 < Pulse Pressure Variation (PPV) < 17, 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 10 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 Jan 2026. 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?
PPV_augmented (time frame: During the last 5 second of lung recruitment maneuver). The study lists 2 primary outcomes in all. 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 Jan 2026.