Mechanical VentilationNCT03511651
The Effect of Positive End-Expiratory Pressure on Functional Residual Capacity During Mechanical Ventilation
A study testing PEEP in people with Mechanical Ventilation and Acute Respiratory Distress Syndrome, run by Capital Medical University at 1 site in China.
Trial summary
Although positive end-expiratory pressure (PEEP) has been widely used in mechanical ventilated patients with acute respiratory distress syndrome (ARDS), how to select the "optimal" PEEP is far from consensus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Ventilation, Acute Respiratory Distress Syndrome, Functional Residual Capacity
- What is being tested?
- PEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 31 Mar 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with ARDS according to the Berlin Definition;
- Age 18-80 years;
- Ventilated with volume-controlled ventilation using constant flow;
- Deep sedation (RASS -4 to -5) and absence of spontaneous breathing (i.e., no triggering during tidal breaths and no inspiratory effort during a 5-second end-expiratory hold).
Who cannot join
- Evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube;
- Chest wall and/or abdominal injuries;
- Evidence suggesting reduced chest wall compliance, such as existing large pleural effusion, thoracic trauma and intra-abdominal hypertension (i.e., intra-abdominal pressure > 20 mmHg).
- Presence of pacemaker, defibrillator, and implantable pumps).
Trial locations and contacts
1 site in 1 country.
China1 site
Jian-Xin Zhou
Beijing, Beijing Municipality, 100050
Jian-Xin Zhou, MD, 8610 67096579, zhoujx.cn@icloud.com
About this study
Although positive end-expiratory pressure (PEEP) has been widely used in mechanical ventilated patients with acute respiratory distress syndrome (ARDS), how to select the "optimal" PEEP is far from consensus. The application of PEEP may result in beneficial effect by recruiting previously collapsed lung areas, harmful effect by over-distending previously aerated lung areas, or a combination of the both. The net effect of PEEP in a certain patient may depend on the recruitability. Because recruitability varies extremely in ARDS patients and strongly correlates with the response to PEEP, estimation of end-expiratory lung volume (EELV) may be essential for individualized setting of PEEP. Whether the FRC changes at different PEEP levels remains unknown.
Read the detailed description
Although positive end-expiratory pressure (PEEP) has been widely used in mechanical ventilated patients with acute respiratory distress syndrome (ARDS), how to select the "optimal" PEEP is far from consensus. The application of PEEP may result in beneficial effect by recruiting previously collapsed lung areas, harmful effect by over-distending previously aerated lung areas, or a combination of the both. The net effect of PEEP in a certain patient may depend on the recruitability. Because recruitability varies extremely in ARDS patients and strongly correlates with the response to PEEP, estimation of end-expiratory lung volume (EELV) may be essential for individualized setting of PEEP.
Passive spirometry has long been used to measure the lung recruitment volume (VREC). A prolonged expiration to zero end-expiratory pressure (ZEEP) or airway release maneuver is required and PEEP induced lung volume change above functional residual capacity (FRC) is measured. This technique assumes that FRC does not change at different PEEP levels.
This assumption that PEEP has no effect on FRC can date back to the study of Valta et al in the early 1990s. Using respiratory inductive plethysmography (RIP), they found that in ALI/ARDS patients, after expiring from different PEEP levels to ZEEP, the plethysmography signal returned to the same baseline value. They concluded that FRC does not change with PEEP, and that changes of EELV are attributable only to change in ∆EELV. Ranieri et al arrived at similar conclusions by measuring differences in lung volumes at different PEEP levels using standardized pressure-volume (P-V) curves derived from the ventilator circuit monitors. However, Patroniti et al found an elevation of FRC as increasing of PEEP in patients with ARDS. In this study, FRC was measured with the helium dilution technique, and concluded that neglecting this effect resulted in marked underestimation of VREC. Whether the FRC changes at different PEEP levels remains controversial. The aim of the study is to assess the effect of PEEP on FRC during mechanical ventilation.
- Being tested
- PEEP
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPProcedure or surgery
Two PEEP levels will be used during mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| FRC at clinical PEEP level | Other | Measuring FRC at clinical PEEP level Receives: Procedure: PEEP |
| FRC at clinical PEEP + 5cmH2O | Experimental | Increasing PEEP to clinical PEEP + 5cmH2O Receives: Procedure: PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of FRC
EELV measurement by ICU ventilator; PEEP Volume measured through airway release. FRC will be calculated as EELV minus PEEP volume. Correlation between EELV, PEEP volume, FRC at two different PEEP levels are tested by linear regression analysis.
Measured: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Secondary outcomes (6)
The change of PaO2/FiO2 Ratio
Obtaining PaO2 according to blood gas analysis, and FiO2 according to the ventilator
Measured: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
The change of regional EELV
Regional EELV will be measured at clinical PEEP and clinical PEEP +5cmH2O
Measured: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
The change of homogeneity of distribution of tidal volume
EIT is used to monitoring the homogeneity of distribution of tidal volume that was divided into two contiguous regions of interest (ROI) equally, the dependent and non-dependent area. The ratio of relative distribution of tidal ventilation of two ROI was calculated.
Measured: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
The change of driving Pressure
The change of driving pressure will be measured.
Measured: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
The change of regional FRC
Regional FRC will be measured at clinical PEEP and clinical PEEP +5cmH2O
Measured: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
The change of blood pressure
The change of blood pressure will be measured
Measured: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start1 Aug 2020 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Capital Medical 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511651
- Sponsor's protocol ID
- KY2018-004-02
- Status last verified
- May 2020
- First submitted
- 8 Apr 2018
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positive End-Expiratory Pressure on Functional Residual Capacity During Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03511651
- Acronym / sponsor ID
- KY2018-004-02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 30 Apr 2018 (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.
Although positive end-expiratory pressure (PEEP) has been widely used in mechanical ventilated patients with acute respiratory distress syndrome (ARDS), how to select the "optimal" PEEP is far from consensus. The application of PEEP may result in beneficial effect by recruiting previously collapsed lung areas, harmful effect by over-distending previously aerated lung areas, or a combination of the both. The net effect of PEEP in a certain patient may depend on the recruitability. Because recruitability varies extremely in ARDS patients and strongly correlates with the response to PEEP, estimation of end-expiratory lung volume (EELV) may be essential for individualized setting of PEEP. Whether the FRC changes at different PEEP levels remains unknown.
Detailed description
Although positive end-expiratory pressure (PEEP) has been widely used in mechanical ventilated patients with acute respiratory distress syndrome (ARDS), how to select the "optimal" PEEP is far from consensus. The application of PEEP may result in beneficial effect by recruiting previously collapsed lung areas, harmful effect by over-distending previously aerated lung areas, or a combination of the both. The net effect of PEEP in a certain patient may depend on the recruitability. Because recruitability varies extremely in ARDS patients and strongly correlates with the response to PEEP, estimation of end-expiratory lung volume (EELV) may be essential for individualized setting of PEEP.
Passive spirometry has long been used to measure the lung recruitment volume (VREC). A prolonged expiration to zero end-expiratory pressure (ZEEP) or airway release maneuver is required and PEEP induced lung volume change above functional residual capacity (FRC) is measured. This technique assumes that FRC does not change at different PEEP levels.
This assumption that PEEP has no effect on FRC can date back to the study of Valta et al in the early 1990s. Using respiratory inductive plethysmography (RIP), they found that in ALI/ARDS patients, after expiring from different PEEP levels to ZEEP, the plethysmography signal returned to the same baseline value. They concluded that FRC does not change with PEEP, and that changes of EELV are attributable only to change in ∆EELV. Ranieri et al arrived at similar conclusions by measuring differences in lung volumes at different PEEP levels using standardized pressure-volume (P-V) curves derived from the ventilator circuit monitors. However, Patroniti et al found an elevation of FRC as increasing of PEEP in patients with ARDS. In this study, FRC was measured with the helium dilution technique, and concluded that neglecting this effect resulted in marked underestimation of VREC. Whether the FRC changes at different PEEP levels remains controversial. The aim of the study is to assess the effect of PEEP on FRC during mechanical ventilation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FRC at clinical PEEP level | Other | Procedure: PEEPMeasuring FRC at clinical PEEP level |
| FRC at clinical PEEP + 5cmH2O | Experimental | Procedure: PEEPIncreasing PEEP to clinical PEEP + 5cmH2O |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with ARDS according to the Berlin Definition;
- Age 18-80 years;
- Ventilated with volume-controlled ventilation using constant flow;
- Deep sedation (RASS -4 to -5) and absence of spontaneous breathing (i.e., no triggering during tidal breaths and no inspiratory effort during a 5-second end-expiratory hold).
Key exclusion criteria (4 listed)
- Evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube;
- Chest wall and/or abdominal injuries;
- Evidence suggesting reduced chest wall compliance, such as existing large pleural effusion, thoracic trauma and intra-abdominal hypertension (i.e., intra-abdominal pressure > 20 mmHg).
- Presence of pacemaker, defibrillator, and implantable pumps).
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 |
|---|---|---|
| PEEPTwo PEEP levels will be used during mechanical ventilation. | Procedure or surgery | FRC at clinical PEEP + 5cmH2O, FRC at clinical PEEP level |
Primary outcome
The change of FRC
Time frame: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
EELV measurement by ICU ventilator; PEEP Volume measured through airway release. FRC will be calculated as EELV minus PEEP volume. Correlation between EELV, PEEP volume, FRC at two different PEEP levels are tested by linear regression analysis.
6 secondary outcomes
The change of PaO2/FiO2 Ratio
Time frame: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
The change of regional EELV
Time frame: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
The change of homogeneity of distribution of tidal volume
Time frame: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
The change of driving Pressure
Time frame: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
The change of regional FRC
Time frame: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
The change of blood pressure
Time frame: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
Related trials for Mechanical Ventilation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingObservational study
DIAPHRAGM STRENGTH AND LUNG VOLUMES
Mechanical Ventilation
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Active, not recruitingObservational study
Potential Impact of the Use of the Application VentilO
Mechanical Ventilation Complication
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.
Jian-Xin Zhou, MD principal investigator
Beijing Tiantan 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 in people with Mechanical Ventilation and Acute Respiratory Distress Syndrome, run by Capital Medical University at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 29 May 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian-Xin Zhou, MD (8610 67096579, zhoujx.cn@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of FRC (time frame: 1) One hour after using clinical PEEP 2) One hour after using clinical PEEP + 5cmH2O). 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 May 2020.