Factors Influencing of Pulse Pressure Variation (PPV) (FacPPV)

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

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.

Study Overview

• Status: Completed
• Conditions: Fluid Responsiveness; Pulse Pressure Variation; Haemodynamics
• Intervention / Treatment: Device: Patients were ventilated with assist-control ventilation（A/C） mode at different tidal volume; Behavioral: spontaneous breathing and no spontaneous breathing

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 189

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Ling Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Circulatory failure patients; Circulatory failure patients requiring fluid responsiveness evaluation

Device: Patients were ventilated with assist-control ventilation（A/C） mode at different tidal volume; Ventilation mode was set to assist-control volume ventilation with different tidal volume, respiratory frequency 15 times/min, PEEP 5 centimeter water column.; Behavioral: spontaneous breathing and no spontaneous breathing; Data were recorded when patients had and did not have spontaneous breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac output(CO)	The measurement of cardiac output(CO);	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of Hemodynamic variables from the monitor;	The investigators record the hemodynamic variables from the monitor MAP and CVP	1 day
measurement of Pulse pressure variation（PPV）from monitor;	Pulse pressure variation (PPV)(percent) ,whic is calculated from the systolic and diastolic blood pressure,can be read from the monitor directly.	Research period
measurement of airway pressure variables from ventilator	The investigators record the airway pressure variables during the inspiration and expiration from the ventilator	1 day
P 0.1	airway occlusion pressure at 100 milliseconds after the onset of inspiration (P0.1)(cmH2O)	1 day
Pocc	delta change of airway pressure during expiratory occlusion in different interventions.	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pes	esophageal pressure	1 day
transpulmonary pressure	transpulmonary pressure and delta transpulmonary pressure	1 day
Outcome	ICU， 28day and hospital mortality	28 day

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Study Director: Haibo Qiu, MD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: February 6, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 7, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: haemodynamics;; Pulse pressure variation;; fluid responsiveness;; Mechanical ventilation
• Other Study ID Numbers: 20210101PPV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No