NCT04802668

Brief Summary

The investigators studied the predictive value of PPV in the patients with different influencing factors;and the method to improve the predictive value,which can improve the application of PPV in ICU.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

March 20, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

February 6, 2021

Last Update Submit

January 7, 2023

Conditions

Keywords

haemodynamics;Pulse pressure variation;fluid responsiveness;Mechanical ventilation;

Outcome Measures

Primary Outcomes (1)

  • cardiac output(CO)

    The measurement of cardiac output(CO);

    1 day

Secondary Outcomes (5)

  • measurement of Hemodynamic variables from the monitor;

    1 day

  • measurement of Pulse pressure variation(PPV)from monitor;

    Research period

  • measurement of airway pressure variables from ventilator

    1 day

  • P 0.1

    1 day

  • Pocc

    1 day

Other Outcomes (3)

  • Pes

    1 day

  • transpulmonary pressure

    1 day

  • Outcome

    28 day

Study Arms (1)

Circulatory failure patients

Circulatory failure patients requiring fluid responsiveness evaluation

Device: Patients were ventilated with assist-control ventilation(A/C) mode at different tidal volumeBehavioral: spontaneous breathing and no spontaneous breathing

Interventions

Ventilation mode was set to assist-control volume ventilation with different tidal volume, respiratory frequency 15 times/min, PEEP 5 centimeter water column.

Circulatory failure patients

Data were recorded when patients had and did not have spontaneous breathing

Circulatory failure patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with circulatory failure selected to enter the Department of Critical Care Medicine

You may qualify if:

  • Patients requiring invasive mechanical ventilation
  • Acute circulatory failure,defined as:systolic blood pressure \<90 mmHg or blood pressure in patients with previous hypertension lower than the baseline value\> 40 mmHg; vasoactive drugs are required to maintain blood pressure (mean arterial pressure\> 65 mmHg); with or without signs of hypoperfusion (oliguria\<0.5ml.kg-1.h-1 for at least 2 hours; arterial blood lactic acid\>2.5mmol.L-1; skin mottling)

You may not qualify if:

  • The age of the patient is less than 18 years old or more than 80 years old
  • Refuse to sign the informed consent to join the group
  • Atrial fibrillation and other arrhythmias that seriously affect the output per beat;
  • With pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ling Liu

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

  • Chen H, Liang M, He Y, Teboul JL, Sun Q, Xie J, Yang Y, Qiu H, Liu L. Inspiratory effort impacts the accuracy of pulse pressure variations for fluid responsiveness prediction in mechanically ventilated patients with spontaneous breathing activity: a prospective cohort study. Ann Intensive Care. 2023 Aug 17;13(1):72. doi: 10.1186/s13613-023-01167-0.

Study Officials

  • Haibo Qiu, MD

    professor

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 6, 2021

First Posted

March 17, 2021

Study Start

March 20, 2021

Primary Completion

March 30, 2022

Study Completion

July 30, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Locations