Monitorings the Physiological Mechanism of Airway Pressure Release Ventilation in ARDS Patients by EIT

ARDS Clinical Trial

Official title:

Monitorings the Physiological Mechanism of Airway Pressure Release Ventilation(APRV) in Acute Respiratory Distress Syndrome (ARDS) Patients by Electrical Impedance Tomography(EIT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05406427
• Other study ID #: EIT20220109
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: June 2022
• Source: Wuhan Union Hospital, China
• Contact: xin zhao, master
• Phone: 15927336285
• Email: 619641364[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Effects of airway pressure release ventilation on pulmonary ventilation, shunt and perfusion in patients with ARDS

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 18 years old < age < 80 years old

2. Diagnosed as moderate or severe ARDS according to the Berlin 2014 definition

3. Predicted APRV mechanical ventilation for more than 72 hours Exclusion Criteria:

Excluded if any of the following exclusion criteria are met:

1. APRV contraindications such as pneumothorax, severe chronic obstructive pulmonary disease, severe asthma, intracranial hypertension

2. Pregnant women

3. 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

4. Refractory shock

5. BMI>35

Related Conditions & MeSH terms

• ARDS
• Electrical Impedance Tomography

Locations

Country	Name	City	State
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (5)

Bellani 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, — View Citation

Kollisch-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. — View Citation

Mauri 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 Coron — View Citation

Safaee 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 COV — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tidal volume distribution during APRV at 24 hours after APRV	we will use electrical impedance tomography(EIT) to monitor tidal volume distribution during APRV	24 hours after APRV mechanical ventilation
Secondary	tidal volume distribution during APRV	tidal volume distribution electrical impedance tomography(EIT) during APRV	Before APRV mechanical ventilation and 2, 6, 12, 48, 72 hours after APRV mechanical ventilation
Secondary	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	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	V/Q match	V/Q match is monitored by EIT	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	tidal volume(Vt)	Vt is the volume of air inhaled or exhaled per breath during mechanical ventilation	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	Plateau pressure	Plateau pressure is the airway pressure at the end of inspiratory pause	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	Positive end breath pressure	Positive end breath pressure(PEEP) is the airway pressure at the end of each breath which is set by clinicians	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	Driving pressure(DP)	DP=Plateau pressure-PEEP	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	Compliances(Cs)	Cs=DP/Vt	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	Peak pressure	Peak pressure is the maximum pressure in the airway during ventilation occurs at the end of inspiration.	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	Mean pressure	Mean pressure is the average airway pressure over a number of breathing cycles	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	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%.	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	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.	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	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).	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	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.	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	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.	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	stroke volume index(SVI)	SVI is monitored by two-dimension ultrasound	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	cardiac index (CI)	The amount of blood pumped by the heart in liters per minute divided by the body surface area in square meters	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	Heart rate(HR)	HR is one of the basic parameters of hemodynamics	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	Systolic blood pressure(SBP)	SBP is one of the basic parameters of hemodynamics	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	Mean arterial pressure (MAP)	MAP is one of the basic parameters of hemodynamics	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	Cardiac output(CO)	The amount of blood expelled from one ventricle per minute	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	Stroke volume	The amount of blood expelled from one ventricle during a single cardiac beat	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	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.	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	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.	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	oxygenation index	oxygenation index=PaO2/fraction of inspired oxygen	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Secondary	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	2 hours within admission to ICU and 24 hours after inclusion in the study
Secondary	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.	2 hours within admission to ICU and 24 hours after inclusion in the study
Secondary	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	from the day of randomization to the day of extubation or the day of death,assessed up to 90 days
Secondary	Mortality at 28 days after randomization	Mortality at 28 days after randomization	28 days after the beginning of randomization
Secondary	ICU length of stay	Duration of ICU stay after randomization until surviving transfer out of ICU	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