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Status unknownNCT03971331Updated Jun 3, 2019

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

An interventional study of PAC catheter and critical care ultrasound examination in Respiratory Distress Syndrome, Adult and Ventricular Dysfunction, Right, sponsored by Kang Yan. Status unknown. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-06-03.

Sponsored by Kang Yan · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
236
Allocation
Non-randomized
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Respiratory Distress Syndrome, Adult
  • Ventricular Dysfunction, Right

Keywords

  • acute respiratory distress syndrome
  • right ventricular dysfunction
  • critical care ultrasound
  • pulmonary artery catheter
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 236 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Kang Yan is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
236 participants (estimated)

Study arms

  • No intervention
    control group

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

  • Experimental
    study group

    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

  • DevicePAC catheter and critical care ultrasound examination

    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

06

What researchers measure

Primary outcomes

  1. 28-day mortality

    28-day mortality after enrollment

    Time frame: 28 days after enrollment

Secondary outcomes

  1. the length of ICU stay

    the length of ICU stay after enrollment

    Time frame: 0-360 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03971331
Lead sponsor
Kang Yan
Responsible party
Kang Yan (Director, West China Hospital) — Sponsor-investigator
First posted
Jun 3, 2019
Start date
Jul 1, 2019 (estimated)
Primary completion
Jun 30, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Jun 3, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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