Clinical trial NCT05406427: Monitorings the Physiological Mechanism of Airway Pressure Release Ventilation in ARDS Patients by EIT
Official title: Monitorings the Physiological Mechanism of Airway Pressure Release Ventilation(APRV) in Acute Respiratory Distress Syndrome (ARDS) Patients by Electrical Impedance Tomography(EIT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Electrical Impedance Tomography
ARDS
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Include as many subjects as possible according to the research protocol

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.

Eligibility criteria: 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

Primary outcomes:
measure: tidal volume distribution during APRV at 24 hours after APRV
timeFrame: 24 hours after APRV mechanical ventilation
Secondary outcomes:
measure: tidal volume distribution during APRV
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 48, 72 hours after APRV mechanical ventilation
measure: Intrapulmonary shunt during APRV
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: V/Q match
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: tidal volume(Vt)
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Plateau pressure
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Positive end breath pressure
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Driving pressure(DP)
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Compliances(Cs)
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Peak pressure
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Mean pressure
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Right ventricular area fractional change
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Tricuspid annular systolic displacement (TAPSE)
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Tricuspid annular systolic S' velocity (TS')
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA)
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Pulmonary circulatory resistance (PVR)
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: stroke volume index(SVI)
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: cardiac index (CI)
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Heart rate(HR)
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Systolic blood pressure(SBP)
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Mean arterial pressure (MAP)
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Cardiac output(CO)
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Stroke volume
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Arterial partial pressure of oxygen (PaO2)
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Arterial partial pressure of carbon dioxide(PaCO2)
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: oxygenation index
timeFrame: Before APRV mechanical ventilation and 2, 6, 12, 24, 48, 72 hours after APRV mechanical ventilation
measure: Sequential Organ Failure Assessment score
timeFrame: 2 hours within admission to ICU and 24 hours after inclusion in the study
measure: Acute Physiology and Chronic Health Evaluation score
timeFrame: 2 hours within admission to ICU and 24 hours after inclusion in the study
measure: Duration of ventilation after randomization
timeFrame: from the day of randomization to the day of extubation or the day of death,assessed up to 90 days
measure: Mortality at 28 days after randomization
timeFrame: 28 days after the beginning of randomization
measure: ICU length of stay
timeFrame: 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
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: xiaojing zou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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 Coronavirus Disease 2019. Crit Care Med. 2020 Aug;48(8):1129-1134. doi: 10.1097/CCM.0000000000004386.
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 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.
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. 2014 Nov;219(5):968-76. doi: 10.1016/j.jamcollsurg.2014.09.011. Epub 2014 Sep 19.