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

Conditions
ARDS
Electrical Impedance Tomography
Registration Number
NCT05406427
Lead Sponsor
Wuhan Union Hospital, China
Brief Summary

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
tidal volume distribution during APRV at 24 hours after APRV24 hours after APRV mechanical ventilation

we will use electrical impedance tomography(EIT) to monitor tidal volume distribution during APRV

Secondary Outcome Measures
NameTimeMethod
tidal volume distribution during APRVBefore APRV mechanical ventilation and 2, 6, 12, 48, 72 hours after APRV mechanical ventilation

tidal volume distribution electrical impedance tomography(EIT) during APRV

Right ventricular area fractional changeBefore APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

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%.

Tricuspid annular systolic S' velocity (TS')Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours 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).

V/Q matchBefore APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

V/Q match is monitored by EIT

Positive end breath pressureBefore APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

Positive end breath pressure(PEEP) is the airway pressure at the end of each breath which is set by clinicians

Tricuspid annular systolic displacement (TAPSE)Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

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.

Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA)Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

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.

Mean arterial pressure (MAP)Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

MAP is one of the basic parameters of hemodynamics

Intrapulmonary shunt during APRVBefore APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

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

Driving pressure(DP)Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

DP=Plateau pressure-PEEP

stroke volume index(SVI)Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

SVI is monitored by two-dimension ultrasound

Mortality at 28 days after randomization28 days after the beginning of randomization

Mortality at 28 days after randomization

Plateau pressureBefore APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

Plateau pressure is the airway pressure at the end of inspiratory pause

Compliances(Cs)Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

Cs=DP/Vt

Peak pressureBefore APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

Peak pressure is the maximum pressure in the airway during ventilation occurs at the end of inspiration.

Pulmonary circulatory resistance (PVR)Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours 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.

cardiac index (CI)Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

The amount of blood pumped by the heart in liters per minute divided by the body surface area in square meters

Heart rate(HR)Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

HR is one of the basic parameters of hemodynamics

tidal volume(Vt)Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

Vt is the volume of air inhaled or exhaled per breath during mechanical ventilation

Mean pressureBefore APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

Mean pressure is the average airway pressure over a number of breathing cycles

Systolic blood pressure(SBP)Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

SBP is one of the basic parameters of hemodynamics

Cardiac output(CO)Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

The amount of blood expelled from one ventricle per minute

Stroke volumeBefore APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

The amount of blood expelled from one ventricle during a single cardiac beat

oxygenation indexBefore APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

oxygenation index=PaO2/fraction of inspired oxygen

ICU length of staythe 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

Duration of ICU stay after randomization until surviving transfer out of ICU

Arterial partial pressure of carbon dioxide(PaCO2)Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

PaCO2 is one of the key indicators of pulmonary ventilation which can be obtained from arterial blood gas analysis.

Sequential Organ Failure Assessment score2 hours within admission to ICU and 24 hours after inclusion in the study

The higher the Sequential Organ Failure Assessment(SOFA) score(0\~24), the higher the disease risk factor and the higher the mortality rate

Arterial partial pressure of oxygen (PaO2)Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation

PaO2 is one of the key indicators of patients' respiratory status which can be obtained from arterial blood gas analysis.

Acute Physiology and Chronic Health Evaluation score2 hours within admission to ICU and 24 hours after inclusion in the study

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.

Duration of ventilation after randomizationfrom the day of randomization to the day of extubation or the day of death,assessed up to 90 days

Time to mechanical ventilation in the ICU after randomization or time to mechanical ventilation after randomization until extubation or death

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

🇨🇳

Wuhan, Hubei, China

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