- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05558826
Pressure Analysis of Trendelenburg Position Effect on Indices From Arterial Pressure
Analysis of Intra-abdominal Pressure and Trendelenburg Position Effect on Dynamic Indices of Arterial Pressure Waveform
Study Overview
Status
Intervention / Treatment
Detailed Description
In this prospective observational study, the investigators will enroll 100 patients undergoing laparoscopic surgery for medical reason. Anesthetic management and surgery will be performed as usual clinical practice.
The investigators will record the digital data exported from standard monitoring instruments, including electrocardiography, photo-plethysmography , blood pressure, neurological system information (Bispectral index and Density spectral array ), the respiratory gas monitoring (gas analyzer and respiratory waveform) and dynamic indices of arterial pressure waveform analysis (cardiac index, stroke volume variation, pulse pressure variation, hypotension prediction index... etc.) from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences) every 20 seconds.
After anesthesia induction as routine clinical practice, slow IV fluid infusion will be maintained. The patient will be placed in Trendelnburg position with different angles ranging from 0-25 degree. CO2 pneumoperitoneum will be created by surgeons for laparoscopic surgery. Changes in levels of intra-abdominal pressure and angles of Trendelenburg position will be recorded. The recording is ended after emergence when surgery ends. All physiological data and demographic data will be stored in digital media after being de-linked from personal identification.
Data analysis and Statistics will be particularly performed to explore the effects of levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform. Methods including signal processing, modeling, classification will be used.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Chien-Kun Ting, MD.PhD
- Phone Number: +886-938593137
- Email: ckting@vghtpe.gov.tw
Study Locations
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-
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Taipei, Taiwan, 11257
- Recruiting
- Taipei Veterans General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged between 20 and 80
- Scheduled for laparoscopic surgery
- American Society of Anesthesiologists (ASA) physical status I to III.
Exclusion Criteria:
- Neurologic or behavioral disorders
- American Society of Anesthesiologists (ASA) physical status ≥ IV
- History of arrhythmia
- Drug abuse or alcoholism
- Resting room air SpO2 < 90%.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke volume variation (SVV)
Time Frame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
|
SVV is the ratio of the maximum (SVmax) SV minus the minimum SV (SVmin) to the mean SV (SVmean), averaged over several respiratory cycles.
SVV is an indicator of a patient's position on the Frank-Starling Curve.
Studies suggested SVV >10 % is associated with fluid responsiveness.
SVV will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
|
Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
|
Pulse pressure variation (PPV)
Time Frame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
|
PPV is the ratio of the maximum pulse pressure (systolic blood pressure minus diastolic blood pressure; PPmax) minus the minimum pulse pressure (PPmin) to the mean pulse pressure (PPmean), averaged over several respiratory cycles.
PPV is an indicator of a patient's position on the Frank-Starling Curve.
Studies suggested PPV >13-15 %is associated with fluid responsiveness.
PPV will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
|
Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
|
Hypotension Prediction Index (HPI)
Time Frame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
|
The Hypotension Prediction Index (HPI) is a prediction model based on features of arterial pressure waveform.
It represents as unitless number from 1 to 100.
Greater number suggested higher risk of a hypotension event occurring in the future.
HPI will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
|
Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
|
Dynamic arterial elastance (Eadyn)
Time Frame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
|
Dynamic arterial elastance (Eadyn) is the ratio of pulse pressure variations (PPV) to stroke volume variations (SVV).
Studies have shown Eadyn as a predictor of blood pressure response to fluid resuscitation in hypotension, fluid-responsive patients.
Eadyn will be obtained and recorded from HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software (Edwards Lifesciences).
|
Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
|
dP/dt
Time Frame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
|
dP/dT (mmHg/second)is the change of left ventricular pressure over time during isovolemic contraction.
It is usually used as a predictor of myocardial contractility.
|
Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bispectral index (BIS) value
Time Frame: BIS monitor are recorded starting from anesthesia induction, and stopped after emergence when surgery ends
|
Our study records these parameters on an observational basis.
Anesthetic management remains identical regardless of patient participation or not.
The recorded BIS value reading is uniform and contains only a unitless number ranging from 0 to 100.
Different procedures do not give different units.
Spectral analysis of the alpha, beta, gamma, theta and delta features of EEG will be performed.
Individual band powers are summed separately.
|
BIS monitor are recorded starting from anesthesia induction, and stopped after emergence when surgery ends
|
Collaborators and Investigators
Investigators
- Study Chair: Chien-Kun Ting, MD.PhD, Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan
Publications and helpful links
General Publications
- Jessen MK, Vallentin MF, Holmberg MJ, Bolther M, Hansen FB, Holst JM, Magnussen A, Hansen NS, Johannsen CM, Enevoldsen J, Jensen TH, Roessler LL, Lind PC, Klitholm MP, Eggertsen MA, Caap P, Boye C, Dabrowski KM, Vormfenne L, Høybye M, Henriksen J, Karlsson CM, Balleby IR, Rasmussen MS, Pælestik K, Granfeldt A, Andersen LW. Goal-directed haemodynamic therapy during general anaesthesia for noncardiac surgery: a systematic review and meta-analysis. Br J Anaesth. 2022 Mar;128(3):416-433. doi: 10.1016/j.bja.2021.10.046. Epub 2021 Dec 13.
- Maheshwari K, Shimada T, Yang D, Khanna S, Cywinski JB, Irefin SA, Ayad S, Turan A, Ruetzler K, Qiu Y, Saha P, Mascha EJ, Sessler DI. Hypotension Prediction Index for Prevention of Hypotension during Moderate- to High-risk Noncardiac Surgery. Anesthesiology. 2020 Dec 1;133(6):1214-1222. doi: 10.1097/ALN.0000000000003557.
- Min JH, Lee SE, Lee HS, Chae YK, Lee YK, Kang Y, Je UJ. The correlation between the Trendelenburg position and the stroke volume variation. Korean J Anesthesiol. 2014 Dec;67(6):378-83. doi: 10.4097/kjae.2014.67.6.378. Epub 2014 Dec 29.
- Davies SJ, Vistisen ST, Jian Z, Hatib F, Scheeren TWL. Ability of an Arterial Waveform Analysis-Derived Hypotension Prediction Index to Predict Future Hypotensive Events in Surgical Patients. Anesth Analg. 2020 Feb;130(2):352-359. doi: 10.1213/ANE.0000000000004121.
- Tavernier B, Robin E. Assessment of fluid responsiveness during increased intra-abdominal pressure: keep the indices, but change the thresholds. Crit Care. 2011;15(2):134. doi: 10.1186/cc10074. Epub 2011 Mar 18.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022-04-002AC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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