Electrical Impedance TomographyNCT05406427
Monitorings the Physiological Mechanism of Airway Pressure Release Ventilation in ARDS Patients by EIT
An observational study of Electrical Impedance Tomography and ARDS, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Effects of airway pressure release ventilation on pulmonary ventilation, shunt and perfusion in patients with ARDS Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Electrical Impedance Tomography, ARDS
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 Mar 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
- Adult, Older adult
Study population: Include as many subjects as possible according to the research protocol
Who may be able to join
- 18 years old < age < 80 years old
- Diagnosed as moderate or severe ARDS according to the Berlin 2014 definition
- Predicted APRV mechanical ventilation for more than 72 hours
Who cannot join
- Excluded if any of the following exclusion criteria are met:
- APRV contraindications such as pneumothorax, severe chronic obstructive pulmonary disease, severe asthma, intracranial hypertension
- Pregnant women
- Severe cardiac dysfunction (New York Heart Association class III or IV, acute coronary syndrome or sustained ventricular tachyarrhythmia), right heart enlargement due to chronic cardiopulmonary disease, cardiogenic shock or cardiac hand
- Refractory shock
- BMI>35
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: Monitorings the Physiological Mechanism of Airway Pressure Release Ventilation(APRV) in Acute Respiratory Distress Syndrome (ARDS) Patients by Electrical Impedance Tomography(EIT)
Effects of airway pressure release ventilation on pulmonary ventilation, shunt and perfusion in patients with ARDS
Read the detailed description
Effects of airway pressure release ventilation on respiratory mechanisms including ventilation distribution, intrapulmonary shunt and V/Q match in lungs of ARDS evaluated by EIT at different time points.
- Conditions
- Electrical Impedance Tomography, ARDS
What is being measured
The primary outcome is the main question the study is designed to answer.
tidal volume distribution during APRV at 24 hours after APRV
we will use electrical impedance tomography(EIT) to monitor tidal volume distribution during APRV
Measured: 24 hours after APRV mechanical ventilation
Secondary outcomes (30)
tidal volume distribution during APRV
tidal volume distribution electrical impedance tomography(EIT) during APRV
Measured: Before APRV mechanical ventilation and 2, 6, 12, 48, 72 hours after APRV mechanical ventilation
Intrapulmonary shunt during APRV
Intrapulmonary shunt percent represented regions that were only perfused calculated as the slope of regional impedance-time curves after saline bolus injection evaluated by EIT
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
V/Q match
V/Q match is monitored by EIT
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
tidal volume(Vt)
Vt is the volume of air inhaled or exhaled per breath during mechanical ventilation
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Plateau pressure
Plateau pressure is the airway pressure at the end of inspiratory pause
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Positive end breath pressure
Positive end breath pressure(PEEP) is the airway pressure at the end of each breath which is set by clinicians
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Driving pressure(DP)
DP=Plateau pressure-PEEP
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Compliances(Cs)
Cs=DP/Vt
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Peak pressure
Peak pressure is the maximum pressure in the airway during ventilation occurs at the end of inspiration.
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Mean pressure
Mean pressure is the average airway pressure over a number of breathing cycles
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Right ventricular area fractional change
Right ventricular area fractional change is a simple and repeatable ultrasound method for evaluating right ventricular function. Methods: The right ventricular end-diastolic area (RVEDA) and right ventricular end- systolic area (RVESA) were measured on the apical four-chamber section by two-dimensional ultrasound. RVAC=(RVEDA- RVESA)/RVEDA*100%.
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Tricuspid annular systolic displacement (TAPSE)
TAPSE: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: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours 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: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours 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 right ventricular function.Methods: The right ventricular end-diastolic area (RVEDA) and left ventricular end-systolic area (LVEDA) were measured on the apical four-chamber section by two-dimensional ultrasound.
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours 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: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
stroke volume index(SVI)
SVI is monitored by two-dimension ultrasound
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
cardiac index (CI)
The amount of blood pumped by the heart in liters per minute divided by the body surface area in square meters
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Heart rate(HR)
HR is one of the basic parameters of hemodynamics
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Systolic blood pressure(SBP)
SBP is one of the basic parameters of hemodynamics
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Mean arterial pressure (MAP)
MAP is one of the basic parameters of hemodynamics
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Cardiac output(CO)
The amount of blood expelled from one ventricle per minute
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Stroke volume
The amount of blood expelled from one ventricle during a single cardiac beat
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Arterial partial pressure of oxygen (PaO2)
PaO2 is one of the key indicators of patients' respiratory status which can be obtained from arterial blood gas analysis.
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Arterial partial pressure of carbon dioxide(PaCO2)
PaCO2 is one of the key indicators of pulmonary ventilation which can be obtained from arterial blood gas analysis.
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
oxygenation index
oxygenation index=PaO2/fraction of inspired oxygen
Measured: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Sequential Organ Failure Assessment score
The higher the Sequential Organ Failure Assessment(SOFA) score(0~24), the higher the disease risk factor and the higher the mortality rate
Measured: 2 hours within admission to ICU and 24 hours after inclusion in the study
Acute Physiology and Chronic Health Evaluation score
The higher the Acute Physiology and Chronic Health Evaluation(APACHE II) score(0~71), the higher the disease risk factor and the higher the mortality rate. In particular, the accuracy of group patient prediction is high.In particular, the accuracy of group patient prediction is high.
Measured: 2 hours within admission to ICU and 24 hours after inclusion in the study
Duration of ventilation after randomization
Time to mechanical ventilation in the ICU after randomization or time to mechanical ventilation after randomization until extubation or death
Measured: from the day of randomization to the day of extubation or the day of death,assessed up to 90 days
Mortality at 28 days after randomization
Mortality at 28 days after randomization
Measured: 28 days after the beginning of randomization
ICU length of stay
Duration of ICU stay after randomization until surviving transfer out of ICU
Measured: the whole period of stay in ICU from the day of randomization to the day of discharge from ICU or the day of death,assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start1 Mar 2022
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Electrical Impedance TomographyStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- 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
- NCT05406427
- Sponsor's protocol ID
- EIT20220109
- Status last verified
- Jun 2022
- First submitted
- 5 Apr 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou 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 28936695Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337Mauri T, Spinelli E, Scotti E, Colussi G, Basile MC, Crotti S, Tubiolo D, Tagliabue P, Zanella A, Grasselli G, Pesenti A. Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019. Crit Care Med. 2020 Aug;48(8):1129-1134. doi: 10.1097/CCM.0000000000004386.
PubMed 32697482Safaee Fakhr B, Araujo Morais CC, De Santis Santiago RR, Di Fenza R, Gibson LE, Restrepo PA, Chang MG, Bittner EA, Pinciroli R, Fintelmann FJ, Kacmarek RM, Berra L. Bedside monitoring of lung perfusion by electrical impedance tomography in the time of COVID-19. Br J Anaesth. 2020 Nov;125(5):e434-e436. doi: 10.1016/j.bja.2020.08.001. Epub 2020 Aug 7. No abstract available.
PubMed 32859359Kollisch-Singule M, Emr B, Smith B, Ruiz C, Roy S, Meng Q, Jain S, Satalin J, Snyder K, Ghosh A, Marx WH, Andrews P, Habashi N, Nieman GF, Gatto LA. Airway pressure release ventilation reduces conducting airway micro-strain in lung injury. J Am Coll Surg. 2014 Nov;219(5):968-76. doi: 10.1016/j.jamcollsurg.2014.09.011. Epub 2014 Sep 19.
PubMed 25440027
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitorings the Physiological Mechanism of Airway Pressure Release Ventilation(APRV) in Acute Respiratory Distress Syndrome (ARDS) Patients by Electrical Impedance Tomography(EIT)
- ClinicalTrials.gov ID
- NCT05406427
- Acronym / sponsor ID
- EIT20220109
- Conditions
- Electrical Impedance Tomography, ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 6 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 airway pressure release ventilation on pulmonary ventilation, shunt and perfusion in patients with ARDS
Detailed description
Effects of airway pressure release ventilation on respiratory mechanisms including ventilation distribution, intrapulmonary shunt and V/Q match in lungs of ARDS evaluated by EIT at different time points.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Include as many subjects as possible according to the research protocol
Key inclusion criteria (3 listed)
- 18 years old < age < 80 years old
- Diagnosed as moderate or severe ARDS according to the Berlin 2014 definition
- Predicted APRV mechanical ventilation for more than 72 hours
Key exclusion criteria (6 listed)
- APRV contraindications such as pneumothorax, severe chronic obstructive pulmonary disease, severe asthma, intracranial hypertension
- Pregnant women
- Severe cardiac dysfunction (New York Heart Association class III or IV, acute coronary syndrome or sustained ventricular tachyarrhythmia), right heart enlargement due to chronic cardiopulmonary disease, cardiogenic shock or cardiac hand
- Refractory shock
- BMI>35
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
tidal volume distribution during APRV at 24 hours after APRV
Time frame: 24 hours after APRV mechanical ventilation
we will use electrical impedance tomography(EIT) to monitor tidal volume distribution during APRV
30 secondary outcomes
tidal volume distribution during APRV
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 48, 72 hours after APRV mechanical ventilation
Intrapulmonary shunt during APRV
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
V/Q match
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
tidal volume(Vt)
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Plateau pressure
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Positive end breath pressure
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Driving pressure(DP)
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Compliances(Cs)
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Peak pressure
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Mean pressure
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Right ventricular area fractional change
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Tricuspid annular systolic displacement (TAPSE)
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Tricuspid annular systolic S' velocity (TS')
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA)
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Pulmonary circulatory resistance (PVR)
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
stroke volume index(SVI)
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
cardiac index (CI)
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Heart rate(HR)
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Systolic blood pressure(SBP)
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Mean arterial pressure (MAP)
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Cardiac output(CO)
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Stroke volume
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Arterial partial pressure of oxygen (PaO2)
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Arterial partial pressure of carbon dioxide(PaCO2)
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
oxygenation index
Time frame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Sequential Organ Failure Assessment score
Time frame: 2 hours within admission to ICU and 24 hours after inclusion in the study
Acute Physiology and Chronic Health Evaluation score
Time frame: 2 hours within admission to ICU and 24 hours after inclusion in the study
Duration of ventilation after randomization
Time frame: from the day of randomization to the day of extubation or the day of death,assessed up to 90 days
Mortality at 28 days after randomization
Time frame: 28 days after the beginning of randomization
ICU length of stay
Time frame: the whole period of stay in ICU from the day of randomization to the day of discharge from ICU or the day of death,assessed up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: 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.
- Results publication: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- Results publication: PubMed 32697482Mauri T, Spinelli E, Scotti E, Colussi G, Basile MC, Crotti S, Tubiolo D, Tagliabue P, Zanella A, Grasselli G, Pesenti A. Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019. Crit Care Med. 2020 Aug;48(8):1129-1134. doi: 10.1097/CCM.0000000000004386.
- Results publication: PubMed 32859359Safaee Fakhr B, Araujo Morais CC, De Santis Santiago RR, Di Fenza R, Gibson LE, Restrepo PA, Chang MG, Bittner EA, Pinciroli R, Fintelmann FJ, Kacmarek RM, Berra L. Bedside monitoring of lung perfusion by electrical impedance tomography in the time of COVID-19. Br J Anaesth. 2020 Nov;125(5):e434-e436. doi: 10.1016/j.bja.2020.08.001. Epub 2020 Aug 7. No abstract available.
- Results publication: PubMed 25440027Kollisch-Singule M, Emr B, Smith B, Ruiz C, Roy S, Meng Q, Jain S, Satalin J, Snyder K, Ghosh A, Marx WH, Andrews P, Habashi N, Nieman GF, Gatto LA. Airway pressure release ventilation reduces conducting airway micro-strain in lung injury. J Am Coll Surg. 2014 Nov;219(5):968-76. doi: 10.1016/j.jamcollsurg.2014.09.011. Epub 2014 Sep 19.
- 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 Electrical Impedance Tomography and ARDS, 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 3 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: status not confirmed, as of the sponsor's last update on 8 Nov 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?
tidal volume distribution during APRV at 24 hours after APRV (time frame: 24 hours after APRV mechanical ventilation). 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 NCT05406427, which also lists 5 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 8 Nov 2022.