HaemodynamicsFacPPVNCT04802668
Factors Influencing of Pulse Pressure Variation (PPV)
An observational study of Haemodynamics and Fluid Responsiveness, run by Southeast University, China at 1 site in China.
Trial summary
The investigators studied the predictive value of PPV in the patients with different influencing factors;and the method to improve the predictive value,which can improve the application of PPV in ICU. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Haemodynamics, Fluid Responsiveness, Pulse Pressure Variation
- What is being tested?
- spontaneous breathing and no spontaneous breathing
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2021to 30 Jul 2022
- 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: Patients with circulatory failure selected to enter the Department of Critical Care Medicine
Who may be able to join
- Patients requiring invasive mechanical ventilation
- Acute circulatory failure,defined as:systolic blood pressure <90 mmHg or blood pressure in patients with previous hypertension lower than the baseline value> 40 mmHg; vasoactive drugs are required to maintain blood pressure (mean arterial pressure> 65 mmHg); with or without signs of hypoperfusion (oliguria<0.5ml.kg-1.h-1 for at least 2 hours; arterial blood lactic acid>2.5mmol.L-1; skin mottling)
Who cannot join
- The age of the patient is less than 18 years old or more than 80 years old
- Refuse to sign the informed consent to join the group
- Atrial fibrillation and other arrhythmias that seriously affect the output per beat;
- With pregnancy
- Other situations where the clinician believes that the patient is not suitable for inclusion in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Influencing the Reliability of Pulse Pressure Variation (PPV) as a Predictor of Fluid Responsiveness in Mechanically Ventilated Patients
The investigators studied the predictive value of PPV in the patients with different influencing factors;and the method to improve the predictive value,which can improve the application of PPV in ICU.
Read the detailed description
PPV can be used to predict fluid responsiveness in patients with circulatory shock.However, it is affected by many factors, which leads to the decrease of the applicability of PPV in ICU.Therefore, the investigators studied the predictive value of PPV in the patients with different influencing factors;and the method to improve the predictive value,which can improve the application of PPV in ICU.
- Being tested
- Patients were ventilated with assist-control ventilation（A/C） mode at different tidal volume, spontaneous breathing and no spontaneous breathing
- Keywords
- haemodynamics;, Pulse pressure variation;, fluid responsiveness;, Mechanical ventilation;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients were ventilated with assist-control ventilation（A/C） mode at different tidal volumeDevice
Ventilation mode was set to assist-control volume ventilation with different tidal volume, respiratory frequency 15 times/min, PEEP 5 centimeter water column.
spontaneous breathing and no spontaneous breathingBehavioural
Data were recorded when patients had and did not have spontaneous breathing
| Study group | Role | What they receive |
|---|---|---|
| Circulatory failure patients | Circulatory failure patients requiring fluid responsiveness evaluation Receives: Device: Patients were ventilated with assist-control ventilation（A/C） mode at different tidal volume; Behavioral: spontaneous breathing and no spontaneous breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac output(CO)
The measurement of cardiac output(CO);
Measured: 1 day
Secondary outcomes (5)
measurement of Hemodynamic variables from the monitor;
The investigators record the hemodynamic variables from the monitor MAP and CVP
Measured: 1 day
measurement of Pulse pressure variation（PPV）from monitor;
Pulse pressure variation (PPV)(percent) ,whic is calculated from the systolic and diastolic blood pressure,can be read from the monitor directly.
Measured: Research period
measurement of airway pressure variables from ventilator
The investigators record the airway pressure variables during the inspiration and expiration from the ventilator
Measured: 1 day
P 0.1
airway occlusion pressure at 100 milliseconds after the onset of inspiration (P0.1)(cmH2O)
Measured: 1 day
Pocc
delta change of airway pressure during expiratory occlusion in different interventions.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start20 Mar 2021
- Primary completion30 Mar 2022
- Study completion30 Jul 2022
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 HaemodynamicsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
- Investigators
- Haibo Qiu, MD, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802668
- Sponsor's protocol ID
- 20210101PPV
- Acronym
- FacPPV
- Status last verified
- Jan 2023
- First submitted
- 6 Feb 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen H, Liang M, He Y, Teboul JL, Sun Q, Xie J, Yang Y, Qiu H, Liu L. Inspiratory effort impacts the accuracy of pulse pressure variations for fluid responsiveness prediction in mechanically ventilated patients with spontaneous breathing activity: a prospective cohort study. Ann Intensive Care. 2023 Aug 17;13(1):72. doi: 10.1186/s13613-023-01167-0.
PubMed 37592166
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Reliability of Pulse Pressure Variation (PPV) as a Predictor of Fluid Responsiveness in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT04802668
- Acronym / sponsor ID
- FacPPV / 20210101PPV
- Keywords
- haemodynamics;, Pulse pressure variation;, fluid responsiveness;, Mechanical ventilation;
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 17 Mar 2021 (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 investigators studied the predictive value of PPV in the patients with different influencing factors;and the method to improve the predictive value,which can improve the application of PPV in ICU.
Detailed description
PPV can be used to predict fluid responsiveness in patients with circulatory shock.However, it is affected by many factors, which leads to the decrease of the applicability of PPV in ICU.Therefore, the investigators studied the predictive value of PPV in the patients with different influencing factors;and the method to improve the predictive value,which can improve the application of PPV in ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Circulatory failure patients | – | Device: Patients were ventilated with assist-control ventilation（A/C） mode at different tidal volume, Behavioral: spontaneous breathing and no spontaneous breathingCirculatory failure patients requiring fluid responsiveness evaluation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with circulatory failure selected to enter the Department of Critical Care Medicine
Key inclusion criteria (2 listed)
- Patients requiring invasive mechanical ventilation
- Acute circulatory failure,defined as:systolic blood pressure <90 mmHg or blood pressure in patients with previous hypertension lower than the baseline value> 40 mmHg; vasoactive drugs are required to maintain blood pressure (mean arterial pressure> 65 mmHg); with or without signs of hypoperfusion (oliguria<0.5ml.kg-1.h-1 for at least 2 hours; arterial blood lactic acid>2.5mmol.L-1; skin mottling)
Key exclusion criteria (5 listed)
- The age of the patient is less than 18 years old or more than 80 years old
- Refuse to sign the informed consent to join the group
- Atrial fibrillation and other arrhythmias that seriously affect the output per beat;
- With pregnancy
- Other situations where the clinician believes that the patient is not suitable for inclusion in the study
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 |
|---|---|---|
| Patients were ventilated with assist-control ventilation（A/C） mode at different tidal volumeVentilation mode was set to assist-control volume ventilation with different tidal volume, respiratory frequency 15 times/min, PEEP 5 centimeter water column. | Device | Circulatory failure patients |
| spontaneous breathing and no spontaneous breathingData were recorded when patients had and did not have spontaneous breathing | Behavioural | Circulatory failure patients |
Primary outcome
cardiac output(CO)
Time frame: 1 day
The measurement of cardiac output(CO);
5 secondary outcomes
measurement of Hemodynamic variables from the monitor;
Time frame: 1 day
measurement of Pulse pressure variation（PPV）from monitor;
Time frame: Research period
measurement of airway pressure variables from ventilator
Time frame: 1 day
P 0.1
Time frame: 1 day
Pocc
Time frame: 1 day
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 10 Jan 2023.
- Derived from this study: PubMed 37592166Chen H, Liang M, He Y, Teboul JL, Sun Q, Xie J, Yang Y, Qiu H, Liu L. Inspiratory effort impacts the accuracy of pulse pressure variations for fluid responsiveness prediction in mechanically ventilated patients with spontaneous breathing activity: a prospective cohort study. Ann Intensive Care. 2023 Aug 17;13(1):72. doi: 10.1186/s13613-023-01167-0.
Related trials for Haemodynamics
Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Angina (Stable), Coronary Artery Disease(CAD)
Not yet recruitingObservational study
Ophthalmic Artery Doppler in the Puerperium After Hypertensive Disorders of Pregnancy (OPHELIA-PP)
Hypertensive Disorders of Pregnancy, Pre-eclampsia
Recruiting
Evaluation of Three Neuromuscular Electrical Stimulation Foot Pad Programmes on Lower Limb Haemodynamics in Healthy Adults
Healthy
Not yet recruiting
Study Aim to Compare the Effect of Different Technique of Airway Managment During Anaesthesia on the Haemodynamics and Intraocular Pressure. Patients Were Divided Into Three Groups of 25 Patients Each. (Group A); Patients Who Were Subjected to LMA Insertion (Group B ).
Congenital Glaucoma
Active, not recruitingObservational study
Investigating Cerebral Oxygenation in the Newborn
Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy
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.
Haibo Qiu, MD study director
professor
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 Haemodynamics and Fluid Responsiveness, run by Southeast University, China 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 2 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 10 Jan 2023. 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?
cardiac output(CO) (time frame: 1 day). 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 NCT04802668, 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 10 Jan 2023.