Post- End- Expiratory Pressure Affect the Alveolar Heterogeneity in Moderate and Sever ARDS Patients

This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.

Study Overview

• Status: Recruiting
• Conditions: Ards
• Intervention / Treatment: Device: Post-end-Expiratory pressure

Detailed Description

ARDS(Acute respiratory distress syndrome )is common in patients suffering Sepsis, trauma, burning and other sever condition and characterized by diffuse alveolar damage and alveolar heterogeneity.ARDS patient need MV(mechanical ventilation )to maintain oxygenation and need unique MV tragedy to avoid VILI(Ventilator induced Lung injury ).PEEP(post-end-expiratory pressure) is crucial to maintain oxygenation and avoid VILI according to researches. But there are also some other research different voice. This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: ling liu, PhD; Phone Number: 13851435472; Email: liulingdoctor@126.com
• Study Contact Backup: Name: haibo qiu, PhD; Phone Number: professor 13951965301; Email: haiboq@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Nanjing Zhong-Da Hospital
      • Contact: Ling Liu, MD.; Phone Number: 86-25-83272201; Email: liulingdoctor@126.com
      • Contact: Haibo Qiu, PhD.,MD.; Phone Number: 86-25-83272200; Email: haiboq2000@yahoo.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Moderate or sever ARDS in 2012 <Berlin definition>;

Description

Inclusion Criteria:

1. Age≥18 or<80；
2. Moderate or sever ARDS in 2012 <Berlin definition>;
3. Applied mechanical ventilation;
4. Consent signed.

Exclusion Criteria:

1. Asthma or COPD；
2. Cardiogenic edema；
3. Sever neutropenia(<500/mm3)；
4. Hemodynamic astatic: DOPA or Dobutamine >15 µg/kg/ min; NE > 15ug /min；
5. GCS coma score ≤12；
6. Thoracic injury or surgery patients contradict EIT ；
7. Refuse to join in trail；
8. Included in other clinical trail。

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
alveolar hyper-distention; alveolar collapse；alveolar opening and closing；	The study use Pulmo Vista 500 device (Drager co.),is intended to perform thoracic bioimpedance measurements by applying the technique of electrical impedance tomography (EIT)to evaluate alveolar hyper-distention(%of the lung volume); alveolar collapse(% of the lung volume)；alveolar opening and closing(% of the lung volume).	September,1,2018-December 30, 2020
Trans-pulmonary pressure	The researchers place tube in the esophagus and connect it to transmitter to measure esophageal pressure (mmHg)and calculate trans-pulmonary pressure(mmHg) to evaluate stress	September,1,2018-December 30, 2020
EELV	The research use nitrogen wash out to measure EELV（end-expiratory lung volume, ml） to calculate dynamic strain and evaluate the strain	September,1,2018-December 30, 2020
peak pressure	The researchers use ventilator to measure peak pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing..	September,1,2018-December 30, 2020
plateau pressure	The researchers use ventilator to do inspiration pause to measure plateau pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing.	September,1,2018-December 30, 2020
tidal volume	The researchers use ventilator to measure tidal volume(ml) in patients with mechanical ventilation and without spontaneous breathing..	September,1,2018-December 30, 2020
respiratory rate	The researchers record the set respiratory rate(bpm) in patients with mechanical ventilation.	September,1,2018-December 30, 2020
flow	The researchers record the set Flow (L/min) in patients with mechanical ventilation.	September,1,2018-December 30, 2020
FiO2	The researchers record the set FiO2 ( fraction of inspiratory oxygen, %) in patients with mechanical ventilation.	September,1,2018-December 30, 2020
PaO2	The researchers use blood gas analysis to measure PaO2( arterial oxygen pressure,mmHg)	September,1,2018-December 30, 2020
PaCO2	The researchers use blood gas analysis to measure PaCO2( arterial carbon dioxide pressure,mmHg) .	September,1,2018-December 30, 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SBP	Recording SBP(systolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.	September,1,2018-December 30, 2020
DBP	Recording DBP(Diastolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.	September,1,2018-December 30, 2020
CVP	Recording CVP(central venous Pressure）,which is always discontinuously monitored with jugular pressure monitor mmHg).	September,1,2018-December 30, 2020
vasopressor	Recording clinical vasopressor usage including Norepinephrine（ μg/Kg/min;）Epinephrine（μg/Kg/min） Dobutamine （ μg/Kg/min)	September,1,2018-December 30, 2020

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Study Director: haibo qiu, PhD, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 17, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: ARDS（Acute respiratory syndrome）;; stress;; strain;; Trans-pulmonary pressure;; FRC(functional residual capacity ); PEEP（post end-expiratory pressure）;; EIT（Electronic impedance tomography）;; RVD(region ventilation delay)
• Other Study ID Numbers: 20181129PEEP

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