The Value of Combined Critical Care Ultrasound and PAC Monitor Oriented Therapy Protocol to Patients of ARDS With ACP

NCT03971331 | Unknown

• 1 other identifier: CUP protocol
• Study Type: interventional
• Target: 236
• Locations: 0 countries
• Sites: N/A

Brief Summary

We hypothesize that combined critical care ultrasound and PAC monitoring-oriented therapy protocol (CUP protocol), would improve prognosis of patients of ARDS with right ventricular dysfunction. Therefore, the overall goal of the study is: 1) To build the combined critical care ultrasound and PAC monitoring-oriented therapy protocol （CUP Protocol）in detail for patients of ARDS with RV dysfunction. Advantage of CUP protocol is that it directly aims at key parameters that we need for the prevention and treatment of such patients; we could improve the mechanical ventilation protocol, unequal pulmonary lesions, hemodynamics management and reduce pulmonary artery pressure according to these parameters, so that to improve the prognosis of the patients.2) To verify the value of CUP Protocol in ARDS with ACP.

Conditions

Respiratory Distress Syndrome, Adult; Ventricular Dysfunction, Right

Keywords

acute respiratory distress syndrome; right ventricular dysfunction; critical care ultrasound; pulmonary artery catheter

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  28-day mortality after enrollment

  28 days after enrollment

Secondary Outcomes (1)

• the length of ICU stay

  0-360 days

Study Arms (2)

control group

NO INTERVENTION

Patients in control group received usual care that was decided by attending.

study group

EXPERIMENTAL

Patients in study group who had been placed the PAC were performed critical care ultrasound(CCUS) to monitor the pathophysiological changes of the lung and the hemodynamics immediately.

Device: PAC catheter and critical care ultrasound examination

Interventions

PAC catheter and critical care ultrasound examination DEVICE

Patients in study group were placed the PAC and performed critical care ultrasound(CCUS) to monitor the pathophysiological changes of the lung and the hemodynamics immediately

study group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age≥18year;
• moderate to severe ARDS（A. Acute onset or aggravated respiratory symptoms within one week; B. Respiratory failure cannot be explained by cardiac dysfunction or fluid overload; C. Bilateral infiltrates cannot be completely explained by pleural effusion, nodules, masses, and collapse; D. When CPAP/PEEP\>5cmH2O, 100mmHg\<PaP2/FiO2\<200mmHg, or CPAP/PEEP\>5cmH2O, PaP2/FiO2\<100mmHg.
• Cardiac ultrasound indicates signs of right ventricular dysfunction (apical four-chamber view showed right ventricular end-diastolic area: left ventricular end-diastolic area ratio\>0.6);
• The informed consent were signed.

You may not qualify if:

• Existing contraindications of PAC, such as right ventricular outflow obstruction, tricuspid valve stenosis, pulmonary artery stenosis, severe bleeding tendency;
• complicated congenital heart disease;
• pregnant;
• patients treated with ECMO.

Sponsors & Collaborators

• Kang Yan: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome; Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 3, 2019
• Study Start: July 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 30, 2021
• Last Updated: June 3, 2019

Record last verified: 2019-05