Mechanical VentilationNCT02976844
Effect of Positive End-expiratory Pressure on Optimal Balloon Volume During Esophageal Pressure Monitoring
An observational study of Mechanical Ventilation, run by Capital Medical University at 1 site in China.
Trial summary
Esophageal pressure (PES), which has been used as a surrogate for pleural pressure. The volume of esophageal balloon can influence the accuracy of monitoring esophageal pressure. The optimal balloon volume is directly dependent on surrounding pressure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- Positive end-expiratory Pressure
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Jan 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: postoperative patients receiving mechanical ventilation
Who may be able to join
- postoperative patients with delayed emergence from general anesthesia admitted to the ICU for mechanical ventilation.
Who cannot join
- age under 18 years;
- diagnosed or suspected esophageal varices;
- history of chronic obstructive pulmonary diseases or asthma;
- history of esophageal, gastric or lung surgery;
- evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or an existing chest tube;
- evidence of severe coagulopathy.
Trial locations and contacts
1 site in 1 country.
China1 site
ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
Official title: Effect of Positive End-expiratory Pressure on Optimal Balloon Volume During Esophageal Pressure Monitoring in Mechanical Ventilated Patients: A Clinical Feasibility Study
Esophageal pressure (PES), which has been used as a surrogate for pleural pressure. The volume of esophageal balloon can influence the accuracy of monitoring esophageal pressure. The optimal balloon volume is directly dependent on surrounding pressure. In the present study,the investigators will observe the optimal volume of esophageal balloon during the different PEEP in bench and clinical study.
Read the detailed description
The esophageal pressure (Pes) is used as a surrogate for pleural pressure to obtain transpulmonary pressure. Catheter with air balloon is the most commonly used method to measure the Pes. The optimal injected volume of the balloon is the key factor in accurate measurement of Pes. The recoil pressure of the balloon turns up while the balloon is over-filled, resulting in over-estimation of the PES; on the other hand, an under-filled balloon also cannot properly transmit the surrounding pressure of balloon. However, the researchers showed the optimal balloon volumes is related to the surrounding pressure and even is not correspond with manufacturer's recommendations. Theoretically, when balloon transmural pressure(PTM) is zero, representing the balloon in a condition with equivalent pressure inside and outside of the balloon, it was defined as optimal volume. However, in clinical settings, it is difficult to determine the balloon PTM, and therefore the optimal volume cannot be obtained, because the surrounding pressure of the balloon cannot be conveniently measured.
In the present study, the investigators will develop a simple method to obtain the optimal balloon volume and observe the effect of positive end-expiratory pressure on optimal balloon volume during esophageal pressure monitoring. The investigators want to validate the accuracy of method in the bench study and clinical feasibility in mechanical ventilated patients.
- Conditions
- Mechanical Ventilation
- Being tested
- Positive end-expiratory Pressure
- Keywords
- optimal balloon volume, positive end-expiratory pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive end-expiratory PressureProcedure or surgery
Positive end-expiratory pressure will be used during mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Low PEEP group | The positive end-expiratory pressure was less than 10cmH2O Receives: Procedure: Positive end-expiratory Pressure | |
| High PEEP group | The positive end-expiratory pressure was higher or equal to 10cmH2O. Receives: Procedure: Positive end-expiratory Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The optimal balloon volume at different PEEP
The 3 minutes after esophageal balloon volume changing, the investigators will record the end-expiratory and end-inspiratory esophageal pressure. The pressure and volume curve will be drawn to determine the optimal volume.
Measured: within 3 minutes after esophageal balloon volume changing
Secondary outcomes (1)
The transpulmonary pressure
Measured: within 3 minutes after esophageal balloon volume changing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2017
- Study completionJan 2017
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 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
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
- NCT02976844
- Sponsor's protocol ID
- KY-2016-11-22
- Status last verified
- Jan 2017
- First submitted
- 23 Nov 2016
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sun XM, Chen GQ, Huang HW, He X, Yang YL, Shi ZH, Xu M, Zhou JX. Use of esophageal balloon pressure-volume curve analysis to determine esophageal wall elastance and calibrate raw esophageal pressure: a bench experiment and clinical study. BMC Anesthesiol. 2018 Feb 14;18(1):21. doi: 10.1186/s12871-018-0488-6.
PubMed 29444644
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Positive End-expiratory Pressure on Optimal Balloon Volume During Esophageal Pressure Monitoring in Mechanical Ventilated Patients: A Clinical Feasibility Study
- ClinicalTrials.gov ID
- NCT02976844
- Acronym / sponsor ID
- KY-2016-11-22
- Conditions
- Mechanical Ventilation
- Keywords
- optimal balloon volume, positive end-expiratory pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 Nov 2016 (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.
Esophageal pressure (PES), which has been used as a surrogate for pleural pressure. The volume of esophageal balloon can influence the accuracy of monitoring esophageal pressure. The optimal balloon volume is directly dependent on surrounding pressure. In the present study,the investigators will observe the optimal volume of esophageal balloon during the different PEEP in bench and clinical study.
Detailed description
The esophageal pressure (Pes) is used as a surrogate for pleural pressure to obtain transpulmonary pressure. Catheter with air balloon is the most commonly used method to measure the Pes. The optimal injected volume of the balloon is the key factor in accurate measurement of Pes. The recoil pressure of the balloon turns up while the balloon is over-filled, resulting in over-estimation of the PES; on the other hand, an under-filled balloon also cannot properly transmit the surrounding pressure of balloon. However, the researchers showed the optimal balloon volumes is related to the surrounding pressure and even is not correspond with manufacturer's recommendations. Theoretically, when balloon transmural pressure(PTM) is zero, representing the balloon in a condition with equivalent pressure inside and outside of the balloon, it was defined as optimal volume. However, in clinical settings, it is difficult to determine the balloon PTM, and therefore the optimal volume cannot be obtained, because the surrounding pressure of the balloon cannot be conveniently measured.
In the present study, the investigators will develop a simple method to obtain the optimal balloon volume and observe the effect of positive end-expiratory pressure on optimal balloon volume during esophageal pressure monitoring. The investigators want to validate the accuracy of method in the bench study and clinical feasibility in mechanical ventilated patients.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low PEEP group | – | Procedure: Positive end-expiratory PressureThe positive end-expiratory pressure was less than 10cmH2O |
| High PEEP group | – | Procedure: Positive end-expiratory PressureThe positive end-expiratory pressure was higher or equal to 10cmH2O. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- postoperative patients receiving mechanical ventilation
Key inclusion criteria (1 listed)
- postoperative patients with delayed emergence from general anesthesia admitted to the ICU for mechanical ventilation.
Key exclusion criteria (6 listed)
- age under 18 years;
- diagnosed or suspected esophageal varices;
- history of chronic obstructive pulmonary diseases or asthma;
- history of esophageal, gastric or lung surgery;
- evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or an existing chest tube;
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 |
|---|---|---|
| Positive end-expiratory PressurePositive end-expiratory pressure will be used during mechanical ventilation. | Procedure or surgery | High PEEP group, Low PEEP group |
Primary outcome
The optimal balloon volume at different PEEP
Time frame: within 3 minutes after esophageal balloon volume changing
The 3 minutes after esophageal balloon volume changing, the investigators will record the end-expiratory and end-inspiratory esophageal pressure. The pressure and volume curve will be drawn to determine the optimal volume.
1 secondary outcome
The transpulmonary pressure
Time frame: within 3 minutes after esophageal balloon volume changing
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 7 Aug 2017.
- Derived from this study: PubMed 29444644Sun XM, Chen GQ, Huang HW, He X, Yang YL, Shi ZH, Xu M, Zhou JX. Use of esophageal balloon pressure-volume curve analysis to determine esophageal wall elastance and calibrate raw esophageal pressure: a bench experiment and clinical study. BMC Anesthesiol. 2018 Feb 14;18(1):21. doi: 10.1186/s12871-018-0488-6.
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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.
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?
An observational study of Mechanical Ventilation, 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 1 inclusion and 6 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 7 Aug 2017. 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?
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 optimal balloon volume at different PEEP (time frame: within 3 minutes after esophageal balloon volume changing). 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 NCT02976844, 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 7 Aug 2017.