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

NCT04934761 | Completed

• 1 other identifier: 202103000022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamics

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (2)

capacity shock

EXPERIMENTAL

2ml/kg succinylateol gelatin

Procedure: Fluid challenge strategy

routine management

OTHER

conventional strategy

Procedure: conventional strategy

Interventions

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.

capacity shock

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.

routine management

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou Red Cross Hospital: lead

Study Sites (1)

Guangzhou Red cross hospital

Guangzhou, Guangdong, 510220, China

Location

Study Officials

• Cao Yang

  Guangzhou Red Cross Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Anesthesiology Physicians

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 22, 2021
• Study Start: June 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 10, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)