Clinical trial NCT04934761: Study on the Effect of Capacity Shock Intervention Under Goal-directed Hemodynamic Management on P-V Loop
Official title: Study on the Effect of Capacity Shock Intervention Under Goal-directed Hemodynamic Management on P-V Loop-based Myocardial Contraction and Work
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamics
Lead sponsor: Guangzhou Red Cross Hospital
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ees
timeFrame: Baseline，After induction
measure: Ees
timeFrame: Immediately after the intervention,complete of the first round of the fluid challenge
measure: Ees
timeFrame: Immediately after the intervention,complete of the second round of the fluid challenge
measure: Ees
timeFrame: 1h after the first fluid challenge
measure: Ees
timeFrame: At the end of surgery
measure: SW
timeFrame: Baseline，after induction
measure: SW
timeFrame: Immediately after the intervention,complete of the first round of the fluid challenge
measure: SW
timeFrame: Immediately after the intervention,complete of the second round of the fluid challenge
measure: SW
timeFrame: 1h after the first fluid challenge
measure: SW
timeFrame: At the end of surgery
measure: Ea
timeFrame: Baseline，after induction
measure: Ea
timeFrame: Immediately after the intervention,complete of the first round of the fluid challenge
measure: Ea
timeFrame: Immediately after the intervention,complete of the second round of the fluid challenge
measure: Ea
timeFrame: 1h after the first fluid challenge
measure: Ea
timeFrame: At the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Red cross hospital
state: Guangdong
Study officials:
affiliation: Guangzhou Red Cross Hospital
name: Cao Yang
role: STUDY_DIRECTOR
References: