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

Ards Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03763890
• Other study ID #: 20181129PEEP
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2022
• Source: Southeast University, China
• Contact: ling Liu, Phd
• Phone: 13851435472
• Email: liulingdoctor[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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?

Related Conditions & MeSH terms

• Ards

Intervention

Device:
• Post-end-Expiratory pressure
Titrate the PEEP from 24 cmH2O to 6 cmH2O, 2 cmH2O/step and record EIT, trans-pulmonary pressure, hemodynamic parameter and Blood-gas analysis.

Locations

Country	Name	City	State
China	Nanjing Zhong-Da Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	respiratory rate	The researchers record the set respiratory rate(bpm) in patients with mechanical ventilation.	September,1,2018-December 30, 2020
Primary	flow	The researchers record the set Flow (L/min) in patients with mechanical ventilation.	September,1,2018-December 30, 2020
Primary	FiO2	The researchers record the set FiO2 ( fraction of inspiratory oxygen, %) in patients with mechanical ventilation.	September,1,2018-December 30, 2020
Primary	PaO2	The researchers use blood gas analysis to measure PaO2( arterial oxygen pressure,mmHg)	September,1,2018-December 30, 2020
Primary	PaCO2	The researchers use blood gas analysis to measure PaCO2( arterial carbon dioxide pressure,mmHg) .	September,1,2018-December 30, 2020
Secondary	SBP	Recording SBP(systolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.	September,1,2018-December 30, 2020
Secondary	DBP	Recording DBP(Diastolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.	September,1,2018-December 30, 2020
Secondary	CVP	Recording CVP(central venous Pressure),which is always discontinuously monitored with jugular pressure monitor mmHg).	September,1,2018-December 30, 2020
Secondary	vasopressor	Recording clinical vasopressor usage including Norepinephrine( µg/Kg/min;)Epinephrine(µg/Kg/min) Dobutamine ( µg/Kg/min)	September,1,2018-December 30, 2020