Ventilation Therapy; ComplicationsNCT05414110
Effect of Airway Pressure Release Ventilation on Right Ventricular Function Assessed by Transthoracic Echocardiography
An observational study of Ventilation Therapy; Complications and Right Ventricular Function, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Effects of APRV on right ventricular function in patients with acute respiratory distress syndrome by transthoracic echocardiography Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventilation Therapy; Complications, Right Ventricular Function, ARDS
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2022to 15 Feb 2024
- 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: Include as many eligible study populations as possible by study protocol
Who may be able to join
- Patients who meet the 2012 Berlin ARDS diagnostic criteria and undergo invasive mechanical ventilation
- PEEP≥5cmH2O, oxygenation index≤200mmHg
- Endotracheal intubation and mechanical ventilation time <48h
- Age ≥18 years old and ≤80 years old
Who cannot join
- Aged less than 18 years old or older than 80 years old
- Obese patients with BMI≥35kg/m2;
- Pregnant and lactating women
- The expected time of invasive mechanical ventilation is expected to be less than 48h
- Neuromuscular disease known to require prolonged mechanical ventilation
- Severe chronic obstructive pulmonary disease
Show all 12Show fewer
- Intracranial hypertension
- Bullae or pneumothorax, subcutaneous emphysema, mediastinal emphysema
- extracorporeal membrane oxygenation(ECMO) has been performed when entering the ICU
- Refractory shock
- Severe cardiac dysfunction (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia), right heart enlargement due to chronic cardiopulmonary disease, cardiogenic shock or heart enlargement postoperative;
- Failure to sign informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
xin zhao, master, 15927336285 ext. 027-85351607, 619641364@qq.com
About this study
Official title: Effect of Airway Pressure Release Ventilation(APRV) on Right Ventricular Function Assessed by Transthoracic Echocardiography
Effects of APRV on right ventricular function in patients with acute respiratory distress syndrome by transthoracic echocardiography
Read the detailed description
Effects of APRV on right ventricular function in patients with acute respiratory distress syndrome(ARDS) by transthoracic echocardiography，which includes TAPSE, S' by TDI, RV FAC, tricuspid regurgitation,RVEDA/LVEDA,RV, Velocity time integration(VTI) of the left ventricular outflow tract blood flow.
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular area fractional change (RV FAC)
Right ventricular area fractional change (RV FAC)is a simple and repeatable ultrasound method for evaluating RV function. Methods: The RV end-diastolic area (RVEDA) and RV end-systolic area (RVESA) were measured on the apical four-chamber section by two-dimensional ultrasound. RV FAC=(RVEDA- RVESA)/RVEDA*100%.
Measured: RV FAC monitoring was performed 1 day after APRV mechanical ventilation
Tricuspid annular systolic displacement(TAPSE)
TAPSE:TAPSE is one of the most effective ultrasound methods for evaluating right ventricular function.Measurement method: TAPSE was measured on the four-chamber section of the apex of the heart by M-mode ultrasound. the sampling line was placed at the side wall of the tricuspid valve ring, parallel to the free wall of the right ventricle as far as possible, and the displacement of the tricuspid valve ring was measured from the end of diastole to the end of systole.
Measured: TAPSE monitoring was performed 1 day after APRV mechanical ventilation
Tricuspid annular systolic S' velocity (TS')
TS' is an objective and accurate ultrasound technique for evaluating right ventricular function.Measurement method:The sample volume was applied to the free wall of the RV and the peak velocity of tricuspid annulus motion was measured in the four-chamber section of the apex by tissue doppler imaging (TDI).
Measured: TS' monitoring was performed 1 day after APRV mechanical ventilation
Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA)
RVEDA/LVEDA a simple and repeatable ultrasound method for evaluating dynamics changes of RV function.Methods: The RV end-diastolic area (RVEDA) and left ventricular(LV) end-systolic area (LVEDA) were measured on the apical four-chamber section by two-dimensional ultrasound.
Measured: RVEDA/LVEDA monitoring was performed 1 day after APRV mechanical ventilation
Pulmonary circulatory resistance (PVR)
Increased PVR can lead to deterioration of RV function.Pulse Doppler imaging (PWD) was used to obtain the pulmonary artery flow spectrum from the pulmonic valve on the short axial section of the parasternal great vessels.
Measured: PVR monitoring was performed 1 day after APRV mechanical ventilation
Secondary outcomes (15)
Heart rate (HR)
HR is a basic element of hemodynamic index
Measured: HR monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended
Systolic blood pressure (SBP)
SBP is basic element of hemodynamic index
Measured: SBP monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended
Mean arterial pressure (MAP)
MAP represents peripheral organ perfusion pressure
Measured: MAP monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended
cardiac output (CO)
CO is an important parameter to reflect the cardiac function of patients
Measured: CO monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
Stroke volume (SV)
Stroke volume is the amount of blood that the ventricle shoots out during a single heart beat.
Measured: SV monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
28-day mortality
28-day mortality after study entry
Measured: Day 28 after study entry
The number of days in ICU
The number of days in ICU(up to 90 days)
Measured: From the day subjects entered ICU to the day left ICU(up to 90 days)
The number of days in hospital
The number of days in hospital(up to 90 days)
Measured: From the day subjects entered hospital to the day left hospital including death(up to 90 days)
in-hospital mortality
Any death occurred during hospitalization(up to 90 days)
Measured: From the day patients admitted to hospital to the day death or discharge(up to 90 days)
Sequential Organ Failure Assessment score
The higher the Sequential Organ Failure Assessment(SOFA) score, the higher the disease risk factor and the higher the mortality rate(The highest score is 24, while the lowest score is 0).
Measured: Within 2 hours admission to ICU and 24 hours after inclusion in the study
Acute Physiology and Chronic Health Evaluation II score
The higher the Acute Physiology and Chronic Health Evaluation II(APACHE II) score, the higher the disease risk factor and the higher the mortality rate(the highest score is 71, while the lowest score is 0).In particular, the accuracy of group patient prediction is high.
Measured: Within 2 hours admission to ICU and 24 hours after inclusion in the study
the effect of APRV ventilation time on right ventricular area fractional change (RV FAC) in ARDS patients
The RV end-diastolic area (RVEDA) and RV end- systolic area (RVESA) were measured on the apical four-chamber section by two-dimensional ultrasound. RV FAC=(RVEDA- RVESA)/RVEDA*100%.
Measured: RV FAC monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
the effect of APRV ventilation time on tricuspid annular systolic displacement (TAPSE) in ARDS patients.
TAPSE was measured on the four-chamber section of the apex of the heart by M-mode ultrasound. the sampling line was placed at the side wall of the tricuspid valve ring, parallel to the free wall of the right ventricle as far as possible, and the displacement of the tricuspid valve ring was measured from the end of diastole to the end of RV systole.
Measured: TAPSE monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
the effect of APRV ventilation time on tricuspid annular systolic S' velocity in ARDS patients.
Tricuspid annular systolic S' velocity is an objective and accurate ultrasound technique for evaluating right ventricular function.Measurement method:The sample volume was applied to the free wall of the RV and the peak velocity of tricuspid annulus motion was measured in the four-chamber section of the apex by tissue doppler imaging (TDI).
Measured: Tricuspid annular systolic S' velocity monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
the effect of APRV ventilation time on right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) in ARDS patients.
RVEDA/LVEDA：RVEDA/LVEDA a simple and repeatable ultrasound method for evaluating dynamics changes of RV function.Methods: The RV end-diastolic area (RVEDA) and LV end-systolic area (lVEDA) were measured on the apical four-chamber section by two-dimensional ultrasound.
Measured: RVEDA/LVEDA monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start3 Apr 2022
- Primary completion15 Feb 2024 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ventilation Therapy; ComplicationsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xiaojing zou, PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414110
- Sponsor's protocol ID
- TTEC20220103
- Status last verified
- Jun 2022
- First submitted
- 5 Apr 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang H, Huang W, Zhang Q, Chen X, Wang X, Liu D; Critical Care Ultrasound Study Group. Prevalence and prognostic value of various types of right ventricular dysfunction in mechanically ventilated septic patients. Ann Intensive Care. 2021 Jul 13;11(1):108. doi: 10.1186/s13613-021-00902-9.
PubMed 34255224Boissier F, Katsahian S, Razazi K, Thille AW, Roche-Campo F, Leon R, Vivier E, Brochard L, Vieillard-Baron A, Brun-Buisson C, Mekontso Dessap A. Prevalence and prognosis of cor pulmonale during protective ventilation for acute respiratory distress syndrome. Intensive Care Med. 2013 Oct;39(10):1725-33. doi: 10.1007/s00134-013-2941-9. Epub 2013 May 15.
PubMed 23673401Dong D, Zong Y, Li Z, Wang Y, Jing C. Mortality of right ventricular dysfunction in patients with acute respiratory distress syndrome subjected to lung protective ventilation: A systematic review and meta-analysis. Heart Lung. 2021 Sep-Oct;50(5):730-735. doi: 10.1016/j.hrtlng.2021.04.011. Epub 2021 Jun 9.
PubMed 34118786Mekontso Dessap A, Boissier F, Charron C, Begot E, Repesse X, Legras A, Brun-Buisson C, Vignon P, Vieillard-Baron A. Acute cor pulmonale during protective ventilation for acute respiratory distress syndrome: prevalence, predictors, and clinical impact. Intensive Care Med. 2016 May;42(5):862-870. doi: 10.1007/s00134-015-4141-2. Epub 2015 Dec 9.
PubMed 26650055Jardin F, Vieillard-Baron A. Right ventricular function and positive pressure ventilation in clinical practice: from hemodynamic subsets to respirator settings. Intensive Care Med. 2003 Sep;29(9):1426-34. doi: 10.1007/s00134-003-1873-1. Epub 2003 Aug 9. No abstract available.
PubMed 12910335Sun X, Liu Y, Li N, You D, Zhao Y. The safety and efficacy of airway pressure release ventilation in acute respiratory distress syndrome patients: A PRISMA-compliant systematic review and meta-analysis. Medicine (Baltimore). 2020 Jan;99(1):e18586. doi: 10.1097/MD.0000000000018586.
PubMed 31895807Zhou Y, Jin X, Lv Y, Wang P, Yang Y, Liang G, Wang B, Kang Y. Early application of airway pressure release ventilation may reduce the duration of mechanical ventilation in acute respiratory distress syndrome. Intensive Care Med. 2017 Nov;43(11):1648-1659. doi: 10.1007/s00134-017-4912-z. Epub 2017 Sep 22.
PubMed 28936695
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Airway Pressure Release Ventilation(APRV) on Right Ventricular Function Assessed by Transthoracic Echocardiography
- ClinicalTrials.gov ID
- NCT05414110
- Acronym / sponsor ID
- TTEC20220103
- Conditions
- Ventilation Therapy; Complications, Right Ventricular Function, ARDS, Transthoracic Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 3 Apr 2022 (actual)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 10 Jun 2022 (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.
Effects of APRV on right ventricular function in patients with acute respiratory distress syndrome by transthoracic echocardiography
Detailed description
Effects of APRV on right ventricular function in patients with acute respiratory distress syndrome(ARDS) by transthoracic echocardiography，which includes TAPSE, S' by TDI, RV FAC, tricuspid regurgitation,RVEDA/LVEDA,RV, Velocity time integration(VTI) of the left ventricular outflow tract blood flow.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Include as many eligible study populations as possible by study protocol
Key inclusion criteria (4 listed)
- Patients who meet the 2012 Berlin ARDS diagnostic criteria and undergo invasive mechanical ventilation
- PEEP≥5cmH2O, oxygenation index≤200mmHg
- Endotracheal intubation and mechanical ventilation time <48h
- Age ≥18 years old and ≤80 years old
Key exclusion criteria (12 listed)
- Aged less than 18 years old or older than 80 years old
- Obese patients with BMI≥35kg/m2;
- Pregnant and lactating women
- The expected time of invasive mechanical ventilation is expected to be less than 48h
- Neuromuscular disease known to require prolonged mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Right ventricular area fractional change (RV FAC)
Time frame: RV FAC monitoring was performed 1 day after APRV mechanical ventilation
Right ventricular area fractional change (RV FAC)is a simple and repeatable ultrasound method for evaluating RV function. Methods: The RV end-diastolic area (RVEDA) and RV end-systolic area (RVESA) were measured on the apical four-chamber section by two-dimensional ultrasound. RV FAC=(RVEDA- RVESA)/RVEDA*100%.
Tricuspid annular systolic displacement(TAPSE)
Time frame: TAPSE monitoring was performed 1 day after APRV mechanical ventilation
TAPSE:TAPSE is one of the most effective ultrasound methods for evaluating right ventricular function.Measurement method: TAPSE was measured on the four-chamber section of the apex of the heart by M-mode ultrasound. the sampling line was placed at the side wall of the tricuspid valve ring, parallel to the free wall of the right ventricle as far as possible, and the displacement of the tricuspid valve ring was measured from the end of diastole to the end of systole.
Tricuspid annular systolic S' velocity (TS')
Time frame: TS' monitoring was performed 1 day after APRV mechanical ventilation
TS' is an objective and accurate ultrasound technique for evaluating right ventricular function.Measurement method:The sample volume was applied to the free wall of the RV and the peak velocity of tricuspid annulus motion was measured in the four-chamber section of the apex by tissue doppler imaging (TDI).
Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA)
Time frame: RVEDA/LVEDA monitoring was performed 1 day after APRV mechanical ventilation
RVEDA/LVEDA a simple and repeatable ultrasound method for evaluating dynamics changes of RV function.Methods: The RV end-diastolic area (RVEDA) and left ventricular(LV) end-systolic area (LVEDA) were measured on the apical four-chamber section by two-dimensional ultrasound.
Pulmonary circulatory resistance (PVR)
Time frame: PVR monitoring was performed 1 day after APRV mechanical ventilation
Increased PVR can lead to deterioration of RV function.Pulse Doppler imaging (PWD) was used to obtain the pulmonary artery flow spectrum from the pulmonic valve on the short axial section of the parasternal great vessels.
15 secondary outcomes
Heart rate (HR)
Time frame: HR monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended
Systolic blood pressure (SBP)
Time frame: SBP monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended
Mean arterial pressure (MAP)
Time frame: MAP monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended
cardiac output (CO)
Time frame: CO monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
Stroke volume (SV)
Time frame: SV monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
28-day mortality
Time frame: Day 28 after study entry
The number of days in ICU
Time frame: From the day subjects entered ICU to the day left ICU(up to 90 days)
The number of days in hospital
Time frame: From the day subjects entered hospital to the day left hospital including death(up to 90 days)
in-hospital mortality
Time frame: From the day patients admitted to hospital to the day death or discharge(up to 90 days)
Sequential Organ Failure Assessment score
Time frame: Within 2 hours admission to ICU and 24 hours after inclusion in the study
Acute Physiology and Chronic Health Evaluation II score
Time frame: Within 2 hours admission to ICU and 24 hours after inclusion in the study
the effect of APRV ventilation time on right ventricular area fractional change (RV FAC) in ARDS patients
Time frame: RV FAC monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
the effect of APRV ventilation time on tricuspid annular systolic displacement (TAPSE) in ARDS patients.
Time frame: TAPSE monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
the effect of APRV ventilation time on tricuspid annular systolic S' velocity in ARDS patients.
Time frame: Tricuspid annular systolic S' velocity monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
the effect of APRV ventilation time on right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA) in ARDS patients.
Time frame: RVEDA/LVEDA monitoring was performed before APRV mechanical ventilation and 6 hours, 12 hours, Day 1, Day 2, Day 3 after APRV mechanical ventilation, and 24 hours after APRV ended by ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Results publication: PubMed 34255224Zhang H, Huang W, Zhang Q, Chen X, Wang X, Liu D; Critical Care Ultrasound Study Group. Prevalence and prognostic value of various types of right ventricular dysfunction in mechanically ventilated septic patients. Ann Intensive Care. 2021 Jul 13;11(1):108. doi: 10.1186/s13613-021-00902-9.
- Results publication: PubMed 23673401Boissier F, Katsahian S, Razazi K, Thille AW, Roche-Campo F, Leon R, Vivier E, Brochard L, Vieillard-Baron A, Brun-Buisson C, Mekontso Dessap A. Prevalence and prognosis of cor pulmonale during protective ventilation for acute respiratory distress syndrome. Intensive Care Med. 2013 Oct;39(10):1725-33. doi: 10.1007/s00134-013-2941-9. Epub 2013 May 15.
- Results publication: PubMed 34118786Dong D, Zong Y, Li Z, Wang Y, Jing C. Mortality of right ventricular dysfunction in patients with acute respiratory distress syndrome subjected to lung protective ventilation: A systematic review and meta-analysis. Heart Lung. 2021 Sep-Oct;50(5):730-735. doi: 10.1016/j.hrtlng.2021.04.011. Epub 2021 Jun 9.
- Results publication: PubMed 26650055Mekontso Dessap A, Boissier F, Charron C, Begot E, Repesse X, Legras A, Brun-Buisson C, Vignon P, Vieillard-Baron A. Acute cor pulmonale during protective ventilation for acute respiratory distress syndrome: prevalence, predictors, and clinical impact. Intensive Care Med. 2016 May;42(5):862-870. doi: 10.1007/s00134-015-4141-2. Epub 2015 Dec 9.
- Results publication: PubMed 12910335Jardin F, Vieillard-Baron A. Right ventricular function and positive pressure ventilation in clinical practice: from hemodynamic subsets to respirator settings. Intensive Care Med. 2003 Sep;29(9):1426-34. doi: 10.1007/s00134-003-1873-1. Epub 2003 Aug 9. No abstract available.
- Results publication: PubMed 31895807Sun X, Liu Y, Li N, You D, Zhao Y. The safety and efficacy of airway pressure release ventilation in acute respiratory distress syndrome patients: A PRISMA-compliant systematic review and meta-analysis. Medicine (Baltimore). 2020 Jan;99(1):e18586. doi: 10.1097/MD.0000000000018586.
- Results publication: PubMed 28936695Zhou Y, Jin X, Lv Y, Wang P, Yang Y, Liang G, Wang B, Kang Y. Early application of airway pressure release ventilation may reduce the duration of mechanical ventilation in acute respiratory distress syndrome. Intensive Care Med. 2017 Nov;43(11):1648-1659. doi: 10.1007/s00134-017-4912-z. Epub 2017 Sep 22.
- Individual participant dataSharing planned: No
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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.
xiaojing zou, PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 Ventilation Therapy; Complications and Right Ventricular Function, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 12 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 10 Jun 2022. 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 xin zhao, master (15927336285 ext. 027-85351607, 619641364@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular area fractional change (RV FAC) (time frame: RV FAC monitoring was performed 1 day after APRV mechanical ventilation). The study lists 5 primary outcomes in all. 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 NCT05414110, which also lists 7 linked publications.
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 Jun 2022.