Clinical trial NCT05558826: Pressure Analysis of Trendelenburg Position Effect on Indices From Arterial Pressure
Official title: Analysis of Intra-abdominal Pressure and Trendelenburg Position Effect on Dynamic Indices of Arterial Pressure Waveform
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Fluid and Electrolyte Imbalance
Hemodynamic Instability
Keywords: Goal directed fluid therapy
Arterial waveform analysis
Pneumoperitoneum
Trendelenburg position
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2022-09-28
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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%.

Primary outcomes:
measure: Stroke volume variation (SVV)
timeFrame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
measure: Pulse pressure variation (PPV)
timeFrame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
measure: Hypotension Prediction Index (HPI)
timeFrame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
measure: Dynamic arterial elastance (Eadyn)
timeFrame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
measure: dP/dt
timeFrame: Dynamic indices recorded starting after anesthesia induction, and stopped after emergence when surgery ends
Secondary outcomes:
measure: Bispectral index (BIS) value
timeFrame: BIS monitor are recorded starting from anesthesia induction, and stopped after emergence when surgery ends
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan
name: Chien-Kun Ting, MD.PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.