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

Sponsor

The Second Affiliated Hospital of Dalian Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04971122

Collaborator

(none)

Enrollment

Location

Arm

10.4

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
The Angle of Trendelenburg	Other: Trendeleburg -5 degree,-10 degree,-15 degree	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jul 15, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

PPV(pulse pressure variation) [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]
Change from PPV at T1to T6
VTI(velocity time integral) [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]
Change from VTI at T1 to T6

Secondary Outcome Measures

SBP(Systolic Blood Pressure) [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]
The variation tendency of T1 to T6
MAP(Mean Artery Pressure) [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]
The variation tendency of T1 to T6
HR HR(Heart Rate) [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]
The variation tendency of T1 to T6

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Dalian Medical University	Dalian	Liaoning	China

Sponsors and Collaborators

The Second Affiliated Hospital of Dalian Medical University

Investigators

Principal Investigator: Dan Hua, Master, Dalian Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Second Affiliated Hospital of Dalian Medical University

ClinicalTrials.gov Identifier:

NCT04971122

Other Study ID Numbers:

yangmi

First Posted:

Jul 21, 2021

Last Update Posted:

Oct 20, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 20, 2021