Evaluation of POC Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Clinical Evaluation of Point-of-care Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03076450
• Other study ID #: 201640405
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2017
• Last updated: April 29, 2017
• Start date: March 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: April 2017
• Source: Shanghai Pudong New Area Gongli Hospital
• Contact: Qiancheng Luo, MM
• Phone: 008613564781737
• Email: luoqiancheng19[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Using lung ultrasound re-aeration score(LUS-RAS) combined with pressure-volume curve(PVC) adjust maintain positive end-expiratory pressure(PEEP) after recruitment maneuver, to achieve real-time adjustment, reduce ventilation-associated lung injury and the purpose of effective lung recruitment.

Description:

The traditional method, set PEEP according to PVC in ARDS mechanical ventilation, lacks morphological evaluation. For point-of-care lung ultrasound(POC-LUS) is non-invasive, real-time, visualization, no need transport patients, getting more and more attention in the ARDS treatment. It has been reported that LUS-RAS is a meaningful assessment in recruitment maneuver. This study will combine POC-LUS with PVC in set the initial peep, and then dynamic record LUS-RAS to feedback regulate PEEP. Using the POC-LUS and maximum oxygenation method to assess lung recruitment effect in experimental group and control group prospectively. The ventilator parameters, state of hemodynamic, arterial blood gas(ABG) in each group will be recorded; Statistical methods will be performed in term to understand the correlation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patient aged 18 years and older

• ARDS patients with invasive mechanical ventilation

Exclusion Criteria:

• Intracranial hypertension

• Pneumothorax and mediastinal emphysema

• Severe hypoxemia (oxygenation index <100)

• Hemodynamic instability

• Chest deformity or surgical history

• Affect Lung-ultrasound conditions: subcutaneous emphysema, chest wound etc.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Lung Ultrasound
Adjust PEEP real-time in term of LUS-RAS chang.

Diagnostic Test:
• Maximum Oxygenation
Adjust PEEP real-time in term of PaO2+PaCO2=400mmHg whether or not.

Locations

Country	Name	City	State
China	Gongli Hospital	Pudong	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Pudong New Area Gongli Hospital	Shanghai Municipal Commission of Health and Family Planning

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Ultrasound re-aeration score, LUS-RAS	The score is composed of 12 different regions of chest wall checked by POC-LUS.	48 hours