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Pressure Analysis of Trendelenburg Position Effect on Indices From Arterial Pressure

NCT05558826 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-09-28

No results posted yet for this study

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

Interventions

DEVICE

HemoSphere advanced monitoring platform with Acumen Hypotension Prediction Index Software

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.

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Principal Investigators

  • Chien-Kun Ting, MD.PhD · Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-10-01
Completion
2024-10-01
FDA Device
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05558826 on ClinicalTrials.gov