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

Primary Purpose

Respiratory Distress Syndrome, Adult, Ventricular Dysfunction, Right

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PAC catheter and critical care ultrasound examination
Sponsored by
Kang Yan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Respiratory Distress Syndrome, Adult focused on measuring acute respiratory distress syndrome, right ventricular dysfunction, critical care ultrasound, pulmonary artery catheter

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1.age≥18year;
  • 2.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.
  • 3.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);
  • 4.The informed consent were signed.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    control group

    study group

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    28-day mortality
    28-day mortality after enrollment

    Secondary Outcome Measures

    the length of ICU stay
    the length of ICU stay after enrollment

    Full Information

    First Posted
    May 30, 2019
    Last Updated
    May 30, 2019
    Sponsor
    Kang Yan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03971331
    Brief Title
    The Value of Combined Critical Care Ultrasound and PAC Monitor Oriented Therapy Protocol to Patients of ARDS With ACP
    Official Title
    The Value of Combined Critical Care Ultrasound and PAC Monitor Oriented Therapy Protocol (CUP Protocol) to Prevention and Treatment of Patients of ARDS(Acute Respiratory Distress Syndrome) With ACP(Acute Cor Pulmonate)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2019 (Anticipated)
    Primary Completion Date
    June 30, 2021 (Anticipated)
    Study Completion Date
    December 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Kang Yan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    ARDS is a hot topic due to its high morbidity and mortality. Severe ACP is independent predictor of mortality of ARDS and mortality of patients of ARDS with ACP is up to 48% to 60%. Therefore, prevention and treatment of ACP is key of improvement of mortality of ARDS patients. The occurrence of ACP is closely related to elevated RV afterload, which is due to pulmonary vascular spasm (caused by hypoxia and hypercapnia) and effect of cardiopulmonary interaction (due to inadequate mechanical ventilation), as well as the factors such as inadequate fluid treatment and other inadequate treatments. Therefore, ARDS with right ventricular dysfunction is hard to treat and easy to aggravate. Critical care ultrasound could show pathophysiologic changes of lung and ventricular interaction and direct etiological treatment and pulmonary artery catheter could perform continuous and accurate monitoring. Therefore, Critical care ultrasound and PAC have their own advantages respectively and is complementary to each other theoretically. Experts opinions recommend echocardiography is mandatory and PAC could be considered in ventilated ARDS patients. However, there is no acknowledged therapeutic protocol, and no one know how to combine these two monitor tools, including specific application protocol, integration of parameters and the decision tree. We had demonstrated the feasibility of combined monitoring protocol oriented delicate fluid management and mechanical ventilation, and the value of kidney protection under systemic treatment of optimized monitoring through the kidney contrast-enhanced ultrasonography. At the same time, we preliminary built the systemic diagnostic and treatment decision tree and provided the way and entry point of our study. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Distress Syndrome, Adult, Ventricular Dysfunction, Right
    Keywords
    acute respiratory distress syndrome, right ventricular dysfunction, critical care ultrasound, pulmonary artery catheter

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    236 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Patients in control group received usual care that was decided by attending.
    Arm Title
    study group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    PAC catheter and critical care ultrasound examination
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    28-day mortality
    Description
    28-day mortality after enrollment
    Time Frame
    28 days after enrollment
    Secondary Outcome Measure Information:
    Title
    the length of ICU stay
    Description
    the length of ICU stay after enrollment
    Time Frame
    0-360 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1.age≥18year; 2.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. 3.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); 4.The informed consent were signed. Exclusion Criteria: 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.

    12. IPD Sharing Statement

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

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