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Completed

NCT Number: NCT04934761

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

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.

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Key information

Conditions

Hemodynamics

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou Red cross hospital

Guangzhou, Guangdong, 510220, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid challenge strategy

Procedure

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.

conventional strategy

Procedure

4ml/kg/h of crystal solution was maintained. We excluded patients whose intraoperative bleeding ≥400ml and operative time ≥5 hours from the group.

Primary outcomes

  1. Ees

    Time frame: Baseline，After induction

    Ees（End-systole Elasticity，mmHg/ml）

  2. Ees

    Time frame: Immediately after the intervention,complete of the first round of the fluid challenge

    Ees（End-systole Elasticity，mmHg/ml）

  3. Ees

    Time frame: Immediately after the intervention,complete of the second round of the fluid challenge

    Arterial elasticity is an invasively determined parameter of arterial load that is inversely related to arterial compliance

  4. Ees

    Time frame: 1h after the first fluid challenge

    Ees（End-systole Elasticity，mmHg/ml）

  5. Ees

    Time frame: At the end of surgery

    Ees（End-systole Elasticity，mmHg/ml）

  6. SW

    Time frame: Baseline，after induction

    SW（Stroke Volume，mmHg·ml）

  7. SW

    Time frame: Immediately after the intervention,complete of the first round of the fluid challenge

    SW（Stroke Volume，mmHg·ml）

  8. SW

    Time frame: Immediately after the intervention,complete of the second round of the fluid challenge

    SW（Stroke Volume，mmHg·ml）

  9. SW

    Time frame: 1h after the first fluid challenge

    SW（Stroke Volume，mmHg·ml）

  10. SW

    Time frame: At the end of surgery

    SW（Stroke Volume，mmHg·ml）

  11. Ea

    Time frame: Baseline，after induction

    Ea(Arterial elasticity, mmHg·ml)

  12. Ea

    Time frame: Immediately after the intervention,complete of the first round of the fluid challenge

    Ea(Arterial elasticity, mmHg·ml)

  13. Ea

    Time frame: Immediately after the intervention,complete of the second round of the fluid challenge

    Ea(Arterial elasticity, mmHg·ml)

  14. Ea

    Time frame: 1h after the first fluid challenge

    Ea(Arterial elasticity, mmHg·ml)

  15. Ea

    Time frame: At the end of surgery

    Ea(Arterial elasticity, mmHg·ml)

Sponsors and collaborators

Lead sponsor

Guangzhou Red Cross Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2021
Registry last updated
Jun 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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