Pressure Analysis of Trendelenburg Position Effect on Indices From Arterial Pressure

NCT05558826 | Unknown FDA Device

• 1 other identifier: 2022-04-002AC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative fluid management is key component of care for patients undergoing surgery. Hypovolemia and hypervolemia both associate with increased morbidity, length of stay in the intensive care unit and mortality. Thus, maintaining adequate intravascular volume yet avoiding fluid overload is crucial to achieve optimal outcomes. Goal-directed fluid therapy based on arterial pressure waveform analysis is widely used for intraoperative fluid management and have been shown to improve surgical outcomes compared with conventional clinical assessment in several studies. However, dynamic indices of arterial pressure waveform analysis such as pulse pressure variation (PPV) and stroke volume variation (SVV) are altered by certain situations including elevated intra-abdominal pressure and Trendelenburg position. Intravascular fluid status might thus be misinterpreted. Carbon dioxide pneumoperitoneum with increased intra-abdominal pressure and Trendelenburg position are commonly seen in laparoscopic surgeries including colorectal, gynecological, and genitourinary procedures. Understanding how dynamic indices change in these clinical situations are essential for achieving appropriate intraoperative fluid management. This study focus on identifying the effects of different levels of intra-abdominal pressure and angles of Trendelenburg position on dynamic indices of arterial pressure waveform.

Conditions

Anesthesia; Fluid and Electrolyte Imbalance; Hemodynamic Instability

Keywords

Goal directed fluid therapy; Arterial waveform analysis; Pneumoperitoneum; Trendelenburg position

Outcome Measures

Primary Outcomes (5)

• Stroke volume variation (SVV)

  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)

  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)

  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)

  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

  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 Outcomes (1)

• Bispectral index (BIS) value

  BIS monitor are recorded starting from anesthesia induction, and stopped after emergence when surgery ends

Interventions

HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software DEVICE

After induction of anesthesia, intra-arterial catheterization will be done for invasive blood pressure monitoring and blood sampling as routine clinical practice for major laparoscopic surgery. Arterial line will be connected to HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software for arterial pressure waveform analysis. Dynamic indices including pulse pressure variation (PPV), stroke volume variation (SVV), Hypotension Prediction Index (HPI), Dynamic arterial elastance (Eadyn) and dP/dt will be continuously recorded. Changes in levels of intra-abdominal pressure and angles of Trendelenburg position will be recorded. 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.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators plan to enroll patients who will laparoscopic surgery under general anesthesia. These patients will be screened for eligibility.

You may qualify if:

• Patients aged between 20 and 80
• Scheduled for laparoscopic surgery
• American Society of Anesthesiologists (ASA) physical status I to III.

You may not qualify if:

• Neurologic or behavioral disorders
• American Society of Anesthesiologists (ASA) physical status ≥ IV
• History of arrhythmia
• Drug abuse or alcoholism
• Resting room air SpO2 \< 90%.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11257, Taiwan

RECRUITING

Related Publications (5)

• 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, Hoybye M, Henriksen J, Karlsson CM, Balleby IR, Rasmussen MS, Paelestik 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.

  PMID: 34916049 BACKGROUND

• 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.

  PMID: 32960954 BACKGROUND

• 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.

  PMID: 25558337 BACKGROUND

• 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.

  PMID: 30896602 BACKGROUND

• 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.

  PMID: 21457517 BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• Chien-Kun Ting, MD.PhD

  Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan

  STUDY CHAIR

Central Study Contacts

Chien-Kun Ting, MD.PhD

CONTACT

+886-938593137; ckting@vghtpe.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: September 28, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)