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

NCT03076450 | Unknown DMC

• 1 other identifier: 201640405
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Lung Ultrasound re-aeration score, LUS-RAS

  The score is composed of 12 different regions of chest wall checked by POC-LUS.

  48 hours

Study Arms (2)

Maximum Oxygenation

ACTIVE COMPARATOR

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

Diagnostic Test: Maximum Oxygenation

Lung Ultrasound Re-aeration Score

EXPERIMENTAL

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

Device: Lung Ultrasound

Interventions

Lung Ultrasound DEVICE

Adjust PEEP real-time in term of LUS-RAS chang.

Lung Ultrasound Re-aeration Score

Maximum Oxygenation DIAGNOSTIC_TEST

Adjust PEEP real-time in term of PaO2+PaCO2≥400mmHg whether or not.

Maximum Oxygenation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient aged 18 years and older
• ARDS patients with invasive mechanical ventilation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pudong New Area Gongli Hospital: lead
• Shanghai Municipal Commission of Health and Family Planning: collaborator

Study Sites (1)

Gongli Hospital

Pudong, Shanghai Municipality, 200135, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qiancheng Luo, MM

  Shanghai Pudong New Area Gongli Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiancheng Luo, MM

CONTACT

008613564781737; luoqiancheng19@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending-doctor of Critical Care Medcine, Principal Investigator

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 10, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 2, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)