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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lung Ultrasound
Maximum Oxygenation
Sponsored by
Shanghai Pudong New Area Gongli Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Acute respiratory distress syndrome, ARDS, Point-of-care lung ultrasound,POC-LUS, Pressure-volume curve, PVC, Positive end-expiratory pressure, PEEP, Ultrasound re-aeration score, US-RAS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gongli HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Maximum Oxygenation

Lung Ultrasound Re-aeration Score

Arm Description

Using PVC to set the initial peep, check ABG real-time, and according to PaO2+PaCO2≥400mmHg whether or not to adjust maintain PEEP.

Combine POC-LUS with PVC in set the initial peep, and then dynamic record LUS-RAS to feedback regulate PEEP.

Outcomes

Primary Outcome Measures

Lung Ultrasound re-aeration score, LUS-RAS
The score is composed of 12 different regions of chest wall checked by POC-LUS.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2017
Last Updated
April 29, 2017
Sponsor
Shanghai Pudong New Area Gongli Hospital
Collaborators
Shanghai Municipal Commission of Health and Family Planning
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1. Study Identification

Unique Protocol Identification Number
NCT03076450
Brief Title
Evaluation of POC Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment
Official Title
Clinical Evaluation of Point-of-care Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Anticipated)
Study Completion Date
September 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pudong New Area Gongli Hospital
Collaborators
Shanghai Municipal Commission of Health and Family Planning

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
Acute respiratory distress syndrome, ARDS, Point-of-care lung ultrasound,POC-LUS, Pressure-volume curve, PVC, Positive end-expiratory pressure, PEEP, Ultrasound re-aeration score, US-RAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maximum Oxygenation
Arm Type
Active Comparator
Arm Description
Using PVC to set the initial peep, check ABG real-time, and according to PaO2+PaCO2≥400mmHg whether or not to adjust maintain PEEP.
Arm Title
Lung Ultrasound Re-aeration Score
Arm Type
Experimental
Arm Description
Combine POC-LUS with PVC in set the initial peep, and then dynamic record LUS-RAS to feedback regulate PEEP.
Intervention Type
Device
Intervention Name(s)
Lung Ultrasound
Intervention Description
Adjust PEEP real-time in term of LUS-RAS chang.
Intervention Type
Diagnostic Test
Intervention Name(s)
Maximum Oxygenation
Intervention Description
Adjust PEEP real-time in term of PaO2+PaCO2≥400mmHg whether or not.
Primary Outcome Measure Information:
Title
Lung Ultrasound re-aeration score, LUS-RAS
Description
The score is composed of 12 different regions of chest wall checked by POC-LUS.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiancheng Luo, MM
Phone
008613564781737
Email
luoqiancheng19@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiancheng Luo, MM
Organizational Affiliation
Shanghai Pudong New Area Gongli Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gongli Hospital
City
Pudong
State/Province
Shanghai
ZIP/Postal Code
200135
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiancheng Luo, MM
Phone
008613564781737
Email
luoqiancheng19@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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