Study on the Effect of Capacity Shock Intervention Under Goal-directed Hemodynamic Management on P-V Loop

Hemodynamics Clinical Trial

Official title:

Study on the Effect of Capacity Shock Intervention Under Goal-directed Hemodynamic Management on P-V Loop-based Myocardial Contraction and Work

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04934761
• Other study ID #: 202103000022
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: June 2021
• Source: Guangzhou Red Cross Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

By observing the changes of P-V loop in capacity shock intervention Under Goal-directed Hemodynamic Management in patients undergoing total knee replacement, we investigate the effect of capacity shock on cardiac contractility and work in order to seek a more effective target plan of capacity shock for intraoperative patients.

Description:

Objective:By observing the changes of P-V loop in capacity shock intervention Under Goal-directed Hemodynamic Management in patients undergoing total knee replacement, we investigate the effect of capacity shock on cardiac contractility and work in order to seek a more effective target plan of capacity shock for intraoperative patients.

Methods:20 patients with total knee replacement were enrolled in this study. Capacity shock therapy was used in Group A(n=10) and conventional strategy was used in Group B (n=10). V(t) was measured and calculated using TEE and P(t) was acquired by the analysis of patients'radial artery pressure waveform. We set five time points of parameter acquisition: after grouping (T1), the first shock completion(T2), the second shock completion (T3), 1h after shock treatment (T4), and operation completion(T5). We make up the P-V loop fitting P(t) and V(t) at each time point after the calibration of cardiac cycle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 10, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

ASAI-II age 40- 70 weight 48 - 72 kg.

Exclusion Criteria:

Body mass index >30 or <15 kg/m2 Valve heart disease Left ventricular ejection fraction (LVEF) is less than 50% History of lung disease Preoperative arrhythmic disorder Permanent pacemaker Need for mechanical heart Support, Severe extrinsic vascular disease Valve dysfunction OED monitoring probe insertion contraindications Patients with preoperative assessments

Related Conditions & MeSH terms

• Hemodynamics

Intervention

Procedure:
• Fluid challenge strategy
Patients received 2ml/kg of succinylateol gelatin within 10 min for fluid shock therapy after grouping, taking SVV as the management target. If SVV< 13% after shock therapy, the shock therapy was stopped and the infusion was maintained with 4ml/kg/h of crystal solution. If SVV = 13% and ?SV <10%, the individual would be excluded from the experiment. If SVV = 13% but ?SV=10%, 2ml/kg of succinylateol gelatin was given again within 10 min for liquid shock therapy until SVV<13%, and 4ml/kg/h of crystal solution was maintained after reaching the target. If SVV= 13% after two shock treatments, they were excluded from the experiment. We excluded patients whose intraoperative bleeding =400ml and operative time =5 hours from the group.
• conventional strategy
4ml/kg/h of crystal solution was maintained. We excluded patients whose intraoperative bleeding =400ml and operative time =5 hours from the group.

Locations

Country	Name	City	State
China	Guangzhou Red cross hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Red Cross Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ees	Ees(End-systole Elasticity,mmHg/ml)	Baseline,After induction
Primary	Ees	Ees(End-systole Elasticity,mmHg/ml)	Immediately after the intervention,complete of the first round of the fluid challenge
Primary	Ees	Arterial elasticity is an invasively determined parameter of arterial load that is inversely related to arterial compliance	Immediately after the intervention,complete of the second round of the fluid challenge
Primary	Ees	Ees(End-systole Elasticity,mmHg/ml)	1h after the first fluid challenge
Primary	Ees	Ees(End-systole Elasticity,mmHg/ml)	At the end of surgery
Primary	SW	SW(Stroke Volume,mmHg·ml)	Baseline,after induction
Primary	SW	SW(Stroke Volume,mmHg·ml)	Immediately after the intervention,complete of the first round of the fluid challenge
Primary	SW	SW(Stroke Volume,mmHg·ml)	Immediately after the intervention,complete of the second round of the fluid challenge
Primary	SW	SW(Stroke Volume,mmHg·ml)	1h after the first fluid challenge
Primary	SW	SW(Stroke Volume,mmHg·ml)	At the end of surgery
Primary	Ea	Ea(Arterial elasticity, mmHg·ml)	Baseline,after induction
Primary	Ea	Ea(Arterial elasticity, mmHg·ml)	Immediately after the intervention,complete of the first round of the fluid challenge
Primary	Ea	Ea(Arterial elasticity, mmHg·ml)	Immediately after the intervention,complete of the second round of the fluid challenge
Primary	Ea	Ea(Arterial elasticity, mmHg·ml)	1h after the first fluid challenge
Primary	Ea	Ea(Arterial elasticity, mmHg·ml)	At the end of surgery