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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemodynamics
• Intervention / Treatment: Procedure: Fluid challenge strategy; Procedure: conventional strategy

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510220
      • Guangzhou Red Cross Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: capacity shock; 2ml/kg succinylateol gelatin	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 ΔSV <10%, the individual would be excluded from the experiment. If SVV ≥ 13% but ΔSV≥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.
OTHER: routine management; conventional strategy	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ees	Ees（End-systole Elasticity，mmHg/ml）	Baseline，After induction
Ees	Ees（End-systole Elasticity，mmHg/ml）	Immediately after the intervention,complete of the first round of the fluid challenge
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
Ees	Ees（End-systole Elasticity，mmHg/ml）	1h after the first fluid challenge
Ees	Ees（End-systole Elasticity，mmHg/ml）	At the end of surgery
SW	SW（Stroke Volume，mmHg·ml）	Baseline，after induction
SW	SW（Stroke Volume，mmHg·ml）	Immediately after the intervention,complete of the first round of the fluid challenge
SW	SW（Stroke Volume，mmHg·ml）	Immediately after the intervention,complete of the second round of the fluid challenge
SW	SW（Stroke Volume，mmHg·ml）	1h after the first fluid challenge
SW	SW（Stroke Volume，mmHg·ml）	At the end of surgery
Ea	Ea(Arterial elasticity, mmHg·ml)	Baseline，after induction
Ea	Ea(Arterial elasticity, mmHg·ml)	Immediately after the intervention,complete of the first round of the fluid challenge
Ea	Ea(Arterial elasticity, mmHg·ml)	Immediately after the intervention,complete of the second round of the fluid challenge
Ea	Ea(Arterial elasticity, mmHg·ml)	1h after the first fluid challenge
Ea	Ea(Arterial elasticity, mmHg·ml)	At the end of surgery

Collaborators and Investigators

• Sponsor: Guangzhou Red Cross Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): May 1, 2021
• Study Completion (ACTUAL): June 10, 2021

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: June 19, 2021
• First Posted (ACTUAL): June 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 19, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 202103000022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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