Factors Influencing of Pulse Pressure Variation (PPV)

Fluid Responsiveness Clinical Trial

— FacPPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04802668
• Other study ID #: 20210101PPV
• Status: Completed
• Start date: March 20, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: January 2023
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: July 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fluid Responsiveness
• Haemodynamics
• Pulse Pressure Variation

Intervention

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

Locations

Country	Name	City	State
China	Ling Liu	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pes	esophageal pressure	1 day
Other	transpulmonary pressure	transpulmonary pressure and delta transpulmonary pressure	1 day
Other	Outcome	ICU, 28day and hospital mortality	28 day
Primary	cardiac output(CO)	The measurement of cardiac output(CO);	1 day
Secondary	measurement of Hemodynamic variables from the monitor;	The investigators record the hemodynamic variables from the monitor MAP and CVP	1 day
Secondary	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
Secondary	measurement of airway pressure variables from ventilator	The investigators record the airway pressure variables during the inspiration and expiration from the ventilator	1 day
Secondary	P 0.1	airway occlusion pressure at 100 milliseconds after the onset of inspiration (P0.1)(cmH2O)	1 day
Secondary	Pocc	delta change of airway pressure during expiratory occlusion in different interventions.	1 day