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Spectral Analysis of Central Venous Pressure Waveform

Spectral Analysis of Central Venous Pressure Waveform in Patients Undergoing Donor Hepatectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04733547
Enrollment
60
Registered
2021-02-02
Start date
2021-02-22
Completion date
2023-11-29
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Venous Catheter, Donor Hepatectomy, Hypovolemia

Brief summary

The use of central venous pressure has been abandoned for the assessment of intravascular volume status. The dynamic fluctuation of central venous pressure according to heart rate is quantitatively measured by spectral analysis of the central venous pressure waveform. Its clinical utility in the assessment of intravascular volume status is investigated.

Detailed description

The use of central venous pressure, which is one of the static preload indices, has been abandoned for the assessment of intravascular volume status because of its unreliability. The static preload indices have been replaced with dynamic preload indices, such as stroke volume variation or pulse pressure variation because the dynamic preload indices reliably predict fluid responsiveness and perform better than the static preload indices. However, the periodic component of central venous pressure, which goes with cardiac cycles, has not been investigated. The power corresponding to heart rate from spectral analysis of central venous pressure waveform represents the extent of the dynamic fluctuation of central venous pressure and is assumed to reflect intravascular volume status. It is hypothesized that the spectral power of central venous pressure corresponding to heart rate represents intravascular volume status.

Interventions

The right internal jugular vein is located at the first rib level under ultrasound-guidance. Using an out-of-plane technique, a needle is introduced into the lumen of the vessel. The aspiration of blood into the syringe connected to the hub of the needle confirms the placement of the needle tip in the lumen. After the syringe is detached from the needle, a guidewire is advanced into the vessel lumen through the needle. A dilator is introduced over the guidewire and subsequently is removed. Then, a central venous catheter is introduced over the guidewire into the vessel lumen through the pathway expanded by the dilator. The catheter tip is placed in the superior vena cava by inserting the catheter as far as the distance between the edge of the right transverse process of the first thoracic vertebra and the carina, which is preoperatively measured on a posteroanterior chest radiograph.

DEVICEMonitoring of central venous pressure

Following the placement of a central venous catheter, a fluid-filled system for monitoring central venous pressure is connected to the proximal lumen of the catheter. The reference transducer is placed at the level of 4/5 of the anteroposterior diameter of the thorax.

DRUGFurosemide-induced hypovolemia before graft procurement

Patients fast from 10 pm the day before surgery. On the arrival at the operating room, an intravenous catheter for Plasmalyte infusion is placed into the right cephalic or basilic vein. The distal lumen of the central venous catheter is used for the infusion of 6% hydroxyethyl starch. Fluid requirements due to anesthesia, surgery, and no per os intake are not replaced by minimizing the administration of the fluids. Five minutes after the collection of the baseline data, 20 mg of furosemide is administered to promote diuresis for facilitating the venous outflow of the liver. An additional dose of furosemide 20 mg is given if the urine output is \<1 ml/kg within 30 minutes after the first dose. Unless the second dose of furosemide produces \>1 ml/kg of urine within 30 minutes, 40 mg of furosemide is administered. In the absence of effective diuresis (1 ml/kg within 30 minutes after each dose), the use of furosemide is abandoned and the patients are excluded from the study.

DRUGReplacement of fluid loss after graft procurement

Immediately after the graft procurement, 500 ml of 6% hydroxyethyl starch are infused over 25 minutes. Afterward, Plasmalyte is infused at a rate of 10 ml/min until the end of surgery.

DEVICEMonitoring of stroke volume variation

Following anesthesia induction, the right radial artery is catheterized. The catheter is connected to the EV1000 monitor (Edwards Lifesciences, Irvine, CA) through the FloTrac transducer (Edwards Lifesciences). The transducer is level with the one for central venous pressure monitoring. Using pulse contour analysis without external calibration, the stroke volume for each heartbeat is measured. At a 20-second interval, stroke volume variation is calculated as (maximum stroke volume - minimum stroke volume)/mean stroke volume.

Sponsors

JongHae Kim
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists physical status 1 * Scheduled for donor hepatectomy under general anesthesia

Exclusion criteria

* Arrhythmia * Valvular heart disease * Coronary artery disease * Cerebrovascular disease * Hypertension * Diabetes mellitus * Renal insufficiency * Pulmonary problems * Any type of liver disease * Body mass index greater than 35 kg/m2 * Human immunodeficiency virus infection * Psychosocial problems * Electrolyte imbalance * Reoperation

Design outcomes

Primary

MeasureTime frameDescription
Spectral power of central venous pressure corresponding to heart rate during 5 minutes before graft procurementDuring 5 minutes before graft procurementA band-pass filter (0.15-3 Hz) is applied to the 5 minute-long segment. The 5 minute-long segments are divided into 100 second-long segments overlapping 50% with each adjacent segment. Each segment is submitted to fast Fourier transformation. The spectral powers obtained from the periodograms of each segment are averaged. The integrated area corresponding to heart rate is the spectral power corresponding to heart rate.

Secondary

MeasureTime frameDescription
Spectral powers of central venous pressure corresponding to respiratory rate and heart rate during 5 minutes after administration of 6% hydroxyethyl starchDuring 5 minutes after administration of 6% hydroxyethyl starchA band-pass filter (0.15-3 Hz) is applied to the 5 minute-long segment. The 5 minute-long segments are divided into 100 second-long segments overlapping 50% with each adjacent segment. Each segment is submitted to fast Fourier transformation. The spectral powers obtained from the periodograms of each segment are averaged. The integrated areas corresponding to respiratory rate and heart rate are the spectral powers corresponding to respiratory rate and heart rate.
Cardiac index during 5 minutes before the first dose of furosemideDuring 5 minutes before the first dose of furosemideThe median of the values calculated at a 20-second interval
Stroke volume variation between 30 and 35 minutes after surgical incisionBetween 30 and 35 minutes after surgical incisionThe median of the values calculated at a 20-second interval
Stroke volume index between 30 and 35 minutes after surgical incisionBetween 30 and 35 minutes after surgical incisionThe median of the values calculated at a 20-second interval
Cardiac index between 30 and 35 minutes after surgical incisionBetween 30 and 35 minutes after surgical incisionThe median of the values calculated at a 20-second interval
Stroke volume variation during 5 minutes before graft procurementDuring 5 minutes before graft procurementThe median of the values calculated at a 20-second interval
Stroke volume index during 5 minutes before graft procurementDuring 5 minutes before graft procurementThe median of the values calculated at a 20-second interval
Cardiac index during 5 minutes before graft procurementDuring 5 minutes before graft procurementThe median of the values calculated at a 20-second interval
Stroke volume variation during 5 minutes after administration of 6% hydroxyethyl starchDuring 5 minutes after administration of 6% hydroxyethyl starchThe median of the values calculated at a 20-second interval
Stroke volume index during 5 minutes after administration of 6% hydroxyethyl starchDuring 5 minutes after administration of 6% hydroxyethyl starchThe median of the values calculated at a 20-second interval
Cardiac index during 5 minutes after administration of 6% hydroxyethyl starchDuring 5 minutes after administration of 6% hydroxyethyl starchThe median of the values calculated at a 20-second interval
Total dose of furosemideAt graft procurementThe total dose of furosemide used for the promotion of diuresis
Urine output at graft procurementAt graft procurementThe total amount of urine output between the placement of urinary catheter and graft procurement
Total urine output at the end of surgeryAt the end of surgeryThe total amount of urine output at the end of surgery
Intraoperative blood loss1 day after surgeryCalculated as blood loss (ml) = \[estimated blood volume\*(preoperative hematocrit-postoperative hematocrit)\]/mean between the 2 hematocrit values, where estimated blood volume (ml) = weight(kg)\^0.425\*height(cm)\^0.725\*0.007184\*2217+age(years)\*1.06 for female and weight(kg)\^0.425\*height(cm)\^0.725\*0.007184\*3064-825 for male
Spectral powers of central venous pressure corresponding to respiratory rate and heart rate during 5 minutes before the first dose of furosemideDuring 5 minutes before the first dose of furosemideA band-pass filter (0.15-3 Hz) is applied to the 5 minute-long segment. The 5 minute-long segments are divided into 100 second-long segments overlapping 50% with each adjacent segment. Each segment is submitted to fast Fourier transformation. The spectral powers obtained from the periodograms of each segment are averaged. The integrated areas corresponding to respiratory rate and heart rate are the spectral powers corresponding to respiratory rate and heart rate.
Spectral powers of central venous pressure corresponding to respiratory rate and heart rate between 30 and 35 minutes after surgical incisionBetween 30 and 35 minutes after surgical incisionA band-pass filter (0.15-3 Hz) is applied to the 5 minute-long segment. The 5 minute-long segments are divided into 100 second-long segments overlapping 50% with each adjacent segment. Each segment is submitted to fast Fourier transformation. The spectral powers obtained from the periodograms of each segment are averaged. The integrated areas corresponding to respiratory rate and heart rate are the spectral powers corresponding to respiratory rate and heart rate.
Spectral power of central venous pressure corresponding to respiratory rate during 5 minutes before graft procurementDuring 5 minutes before graft procurementA band-pass filter (0.15-3 Hz) is applied to the 5 minute-long segment. The 5 minute-long segments are divided into 100 second-long segments overlapping 50% with each adjacent segment. Each segment is submitted to fast Fourier transformation. The spectral powers obtained from the periodograms of each segment are averaged. The integrated area corresponding to respiratory rate is the spectral power corresponding to respiratory rate.
Stroke volume variation during 5 minutes before the first dose of furosemideDuring 5 minutes before the first dose of furosemideThe median of the values calculated at a 20-second interval
Stroke volume index during 5 minutes before the first dose of furosemideDuring 5 minutes before the first dose of furosemideThe median of the values calculated at a 20-second interval

Other

MeasureTime frameDescription
HeightThe day before surgeryMeasured in cm
WeightThe day before surgeryMeasured in kg
Aspartate transaminaseThe day before surgeryMeasured in U/L
Alanine transaminaseThe day before surgeryMeasured in U/L
Blood urea nitrogenThe day before surgeryMeasured in mg/dl
CreatinineThe day before surgeryMeasured in mg/dl
Serum sodium levelThe day before surgeryMeasured in mmol/L
Serum potassium levelThe day before surgeryMeasured in mmol/L
Serum chloride levelThe day before surgeryMeasured in mmol/L
Graft weightAt graft procurementMeasured in gram
Total amount of fluidsAt the end of surgeryThe total volume of colloids and crystalloids administered throughout the entire surgery
Serum chloride1 hour after surgeryMeasured in mmol/L
SexOn arrival at the operating roomBiological sex
AgeOn arrival at the operating roomAge at the time of surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026