Comparison of the Effects of Trendelenburg Position and Passive Leg Lift on Hemodynamics in Abdominal Surgery Patients

How to maintain the stability of circulation during anesthesia has always been a concern of clinicians, including shorting the preoperative fasting time under the condition of full preoperative preparation, and giving appropriate amount of nutrient solution in combination with the patient's situation 2~4 h before surgery to reduce the blood volume insufficiency of patients before general anesthesia induction, vasoactive drugs, etc. Among them, passive leg lifting experiment is widely recognized in the world. Although passive leg lifting has many advantages, it still has some limitations in the operation process. This study tried to find the corresponding head low and foot high Angle corresponding to the same hemodynamic changes caused by passive leg lifting.

Study Overview

• Status: Recruiting
• Conditions: The Angle of Trendelenburg
• Intervention / Treatment: Other: Trendeleburg -5 degree,-10 degree,-15 degree

Detailed Description

For low head and high feet, studies have shown that 20° can reduce the incidence of hypotension during the induction period of general anesthesia in patients undergoing gastrectomy and has therapeutic effect on it, as well as reduce the use of vasoactive drugs during the induction period of general anesthesia. There were no perioperative complications.

The passive leg lift test can be repeated and does not overload the patient with fluid. However, there is no relevant research on the relationship between the two, which is exactly the innovation of this topic.

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanan Pu, Master; Phone Number: 17709870962; Email: 812916877@qq.com
• Study Contact Backup: Name: Dan Hua, Master; Phone Number: 17709862909; Email: 3078416475@qq.com

Study Locations

• China
  • Liaoning
    • Dalian, Liaoning, China
      • Recruiting
      • The Second Affiliated Hospital of Dalian Medical University
      • Contact: dan hua, master; Phone Number: 17709862909
      • Contact: yanan pu, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18~75 years old
• Good image of TTE can be obtained
• Sedative mechanical ventilation （Vt 8～10ml/kg）
• Circulation was relatively stable before the experiment began
• There is no contraindication to rehydration

Exclusion Criteria:

• TTE acquisition is not ideal
• Patients did not agree to participate in the experiment
• Diseases of the central nervous system，patients with increased intracranial pressure
• Arrhythmia patients;
• Patients with increased intra-abdominal pressure;
• Bedridden patients;
• Patients with venous thrombosis of lower limbs;
• Patients with venous foreign body of lower limbs;
• Patients with circulatory instability;
• Patients with obstructive shock;
• Patients with moderate or above heart valve reflux

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Trendeleburg -5 degree group,-10 degree group,-15 degree group; Norepinephrine was continuously pumped at 0.5ug/kg/min	Other: Trendeleburg -5 degree,-10 degree,-15 degree; Use a -5 or -10 or -15 degree trendelenburg position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PPV(pulse pressure variation)	Change from PPV at T1to T6	T1:A supine position with a 10° upward bed angulation；T2: After passive leg lift；T3：The same position with T1；T4:After trendelenburg position；T5:The same position with T1;T6:After fluid infusion
VTI(velocity time integral)	Change from VTI at T1 to T6	T1:A supine position with a 10° upward bed angulation；T2: After passive leg lift；T3：The same position with T1；T4:After trendelenburg position；T5:The same position with T1;T6:After fluid infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SBP(Systolic Blood Pressure)	The variation tendency of T1 to T6	T1:A supine position with a 10° upward bed angulation；T2: After passive leg lift；T3：The same position with T1；T4:After trendelenburg position；T5:The same position with T1;T6:After fluid infusion
MAP(Mean Artery Pressure)	The variation tendency of T1 to T6	T1:A supine position with a 10° upward bed angulation；T2: After passive leg lift；T3：The same position with T1；T4:After trendelenburg position；T5:The same position with T1;T6:After fluid infusion
HR HR(Heart Rate)	The variation tendency of T1 to T6	T1:A supine position with a 10° upward bed angulation；T2: After passive leg lift；T3：The same position with T1；T4:After trendelenburg position；T5:The same position with T1;T6:After fluid infusion

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Dalian Medical University
• Investigators: Principal Investigator: Dan Hua, Master, Dalian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): July 15, 2022

Study Registration Dates

• First Submitted: June 20, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: yangmi

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