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

NCT03763890 | Unknown DMC

• 1 other identifier: 20181129PEEP
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ards

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)

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (4)

• SBP

  September,1,2018-December 30, 2020

• DBP

  September,1,2018-December 30, 2020

• CVP

  September,1,2018-December 30, 2020

• vasopressor

  September,1,2018-December 30, 2020

Interventions

Post-end-Expiratory pressure DEVICE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate or sever ARDS in 2012 \<Berlin definition\>;

You may qualify if:

• Age≥18 or\<80；
• Moderate or sever ARDS in 2012 \<Berlin definition\>;
• Applied mechanical ventilation;
• Consent signed.

You may not qualify if:

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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Nanjing Zhong-Da Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury; Sprains and Strains

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Wounds and Injuries

Study Officials

• haibo qiu, PhD

  Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China

  STUDY DIRECTOR

Central Study Contacts

ling Liu, Phd

CONTACT

13851435472; liulingdoctor@126.com

haibo qiu, PhD

CONTACT

13951965301; haiboq@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 4, 2018
• Study Start: September 1, 2018
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)