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NCT Number: NCT04802668

Factors Influencing of Pulse Pressure Variation (PPV)

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.

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Key information

Conditions

Haemodynamics Fluid Responsiveness Pulse Pressure Variation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ling Liu

Nanjing, Jiangsu, 210009, China

About this study

PPV can be used to predict fluid responsiveness in patients with circulatory shock.However, it is affected by many factors, which leads to the decrease of the applicability of PPV in ICU.Therefore, 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • Other situations where the clinician believes that the patient is not suitable for inclusion in the study

Treatment and study plan

Patients were ventilated with assist-control ventilation（A/C） mode at different tidal volume

Device

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

spontaneous breathing and no spontaneous breathing

Behavioral

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

Primary outcomes

  1. cardiac output(CO)

    Time frame: 1 day

    The measurement of cardiac output(CO);

Secondary outcomes

  1. measurement of Hemodynamic variables from the monitor;

    Time frame: 1 day

    The investigators record the hemodynamic variables from the monitor MAP and CVP

  2. measurement of Pulse pressure variation（PPV）from monitor;

    Time frame: Research period

    Pulse pressure variation (PPV)(percent) ,whic is calculated from the systolic and diastolic blood pressure,can be read from the monitor directly.

  3. measurement of airway pressure variables from ventilator

    Time frame: 1 day

    The investigators record the airway pressure variables during the inspiration and expiration from the ventilator

  4. P 0.1

    Time frame: 1 day

    airway occlusion pressure at 100 milliseconds after the onset of inspiration (P0.1)(cmH2O)

  5. Pocc

    Time frame: 1 day

    delta change of airway pressure during expiratory occlusion in different interventions.

Other outcomes

  1. Pes

    Time frame: 1 day

    esophageal pressure

  2. transpulmonary pressure

    Time frame: 1 day

    transpulmonary pressure and delta transpulmonary pressure

  3. Outcome

    Time frame: 28 day

    ICU， 28day and hospital mortality

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

Factors Influencing the Reliability of Pulse Pressure Variation (PPV) as a Predictor of Fluid Responsiveness in Mechanically Ventilated Patients

Acronym: FacPPV

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2021
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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