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

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

Study Overview

• Status: Recruiting
• Conditions: ARDS; Electrical Impedance Tomography

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: xin zhao, master; Phone Number: 027-85351607 15927336285; Email: 619641364@qq.com
• Study Contact Backup: Name: xiaojing zou, PhD; Phone Number: 027-85351607 13995518630; Email: 249126734@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: xin zhao, master; Phone Number: 027-85351607 15927336285; Email: 619641364@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Include as many subjects as possible according to the research protocol

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Driving pressure(DP)	DP=Plateau pressure-PEEP	Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
Compliances(Cs)	Cs=DP/Vt	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.	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	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%.	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.	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).	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.	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.	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	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	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	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	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	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	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	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.	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.	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	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	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.	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	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	28 days after the beginning of randomization
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

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: xiaojing zou, PhD, Wuhan Union Hospital, China

Publications and helpful links

General Publications

• 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, 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. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.
• 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.
• 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 Coronavirus Disease 2019. Crit Care Med. 2020 Aug;48(8):1129-1134. doi: 10.1097/CCM.0000000000004386.
• 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 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.
• 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. 2014 Nov;219(5):968-76. doi: 10.1016/j.jamcollsurg.2014.09.011. Epub 2014 Sep 19. Erratum In: J Am Coll Surg. 2016 Nov;223(5):743.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: EIT20220109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No