The Angle of TrendelenburgNCT04971122
Comparison of the Effects of Trendelenburg Position and Passive Leg Lift on Hemodynamics in Abdominal Surgery Patients
A study testing Trendeleburg -5 degree,-10 degree,-15 degree in people with The Angle of Trendelenburg, run by The Second Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- The Angle of Trendelenburg
- What is being tested?
- Trendeleburg -5 degree,-10 degree,-15 degree
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
dan hua, master, 17709862909
yanan pu, master
About this study
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.
Read the 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.
- Conditions
- The Angle of Trendelenburg
- Being tested
- Trendeleburg -5 degree,-10 degree,-15 degree
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trendeleburg -5 degree,-10 degree,-15 degreeOther
Use a -5 or -10 or -15 degree trendelenburg position
| Study group | Role | What they receive |
|---|---|---|
| Trendeleburg -5 degree group,-10 degree group,-15 degree group | Other | Norepinephrine was continuously pumped at 0.5ug/kg/min Receives: Other: Trendeleburg -5 degree,-10 degree,-15 degree |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPV(pulse pressure variation)
Change from PPV at T1to T6
Measured: 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
Measured: 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 outcomes (3)
SBP(Systolic Blood Pressure)
The variation tendency of T1 to T6
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Sep 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Angle of TrendelenburgStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Hua, Master, Principal investigator, Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971122
- Sponsor's protocol ID
- yangmi
- Status last verified
- Oct 2021
- First submitted
- 20 Jun 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Trendelenburg Position and Passive Leg Lift on Hemodynamics in Abdominal Surgery Patients
- ClinicalTrials.gov ID
- NCT04971122
- Acronym / sponsor ID
- yangmi
- Conditions
- The Angle of Trendelenburg
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trendeleburg -5 degree group,-10 degree group,-15 degree group | Other | Other: Trendeleburg -5 degree,-10 degree,-15 degreeNorepinephrine was continuously pumped at 0.5ug/kg/min |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trendeleburg -5 degree,-10 degree,-15 degreeUse a -5 or -10 or -15 degree trendelenburg position | Other | Trendeleburg -5 degree group,-10 degree group,-15 degree group |
Primary outcome
PPV(pulse pressure variation)
Time frame: 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)
Time frame: 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
3 secondary outcomes
SBP(Systolic Blood Pressure)
Time frame: 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)
Time frame: 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)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Hua, Master principal investigator
Dalian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trendeleburg -5 degree,-10 degree,-15 degree in people with The Angle of Trendelenburg, run by The Second Affiliated Hospital of Dalian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanan Pu, Master (17709870962, 812916877@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPV(pulse pressure variation) (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.