Spectral Analysis of Central Venous Pressure Waveform

Hypovolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04733547
• Other study ID #: CR-21-007
• Status: Completed
• Start date: February 22, 2021
• Est. completion date: November 29, 2023

Study information

• Verified date: December 2023
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Venous Catheter
• Donor Hepatectomy
• Hypovolemia

Intervention

Procedure:
• Placement of a central venous catheter
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.

Device:
• Monitoring 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.

Drug:
• Furosemide-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.
• Replacement 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.

Device:
• Monitoring 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.

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
JongHae Kim

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Alian AA, Galante NJ, Stachenfeld NS, Silverman DG, Shelley KH. Impact of lower body negative pressure induced hypovolemia on peripheral venous pressure waveform parameters in healthy volunteers. Physiol Meas. 2014 Jul;35(7):1509-20. doi: 10.1088/0967-3334/35/7/1509. Epub 2014 Jun 5. — View Citation

Hocking KM, Alvis BD, Baudenbacher F, Boyer R, Brophy CM, Beer I, Eagle S. Peripheral i.v. analysis (PIVA) of venous waveforms for volume assessment in patients undergoing haemodialysis. Br J Anaesth. 2017 Dec 1;119(6):1135-1140. doi: 10.1093/bja/aex271. — View Citation

Hocking KM, Sileshi B, Baudenbacher FJ, Boyer RB, Kohorst KL, Brophy CM, Eagle SS. Peripheral Venous Waveform Analysis for Detecting Hemorrhage and Iatrogenic Volume Overload in a Porcine Model. Shock. 2016 Oct;46(4):447-52. doi: 10.1097/SHK.0000000000000615. — View Citation

Sileshi B, Hocking KM, Boyer RB, Baudenbacher FJ, Kohurst KL, Brophy CM, Eagle S. Peripheral venous waveform analysis for detecting early hemorrhage: a pilot study. Intensive Care Med. 2015 Jun;41(6):1147-8. doi: 10.1007/s00134-015-3787-0. Epub 2015 Apr 11. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	Age at the time of surgery	On arrival at the operating room
Other	Sex	Biological sex	On arrival at the operating room
Other	Height	Measured in cm	The day before surgery
Other	Weight	Measured in kg	The day before surgery
Other	Aspartate transaminase	Measured in U/L	The day before surgery
Other	Alanine transaminase	Measured in U/L	The day before surgery
Other	Blood urea nitrogen	Measured in mg/dl	The day before surgery
Other	Creatinine	Measured in mg/dl	The day before surgery
Other	Serum sodium level	Measured in mmol/L	The day before surgery
Other	Serum potassium level	Measured in mmol/L	The day before surgery
Other	Serum chloride level	Measured in mmol/L	The day before surgery
Other	Graft weight	Measured in gram	At graft procurement
Other	Total amount of fluids	The total volume of colloids and crystalloids administered throughout the entire surgery	At the end of surgery
Other	Aspartate transaminase	Measured in U/L	1 hour after surgery
Other	Alanine transaminase	Measured in U/L	1 hour after surgery
Other	Blood urea nitrogen	Measured in mg/dl	1 hour after surgery
Other	Creatinine	Measured in mg/dl	1 hour after surgery
Other	Serum sodium level	Measured in mmol/L	1 hour after surgery
Other	Serum potassium level	Measured in mmol/L	1 hour after surgery
Other	Serum chloride	Measured in mmol/L	1 hour after surgery
Primary	Spectral power of central venous pressure corresponding to heart rate during 5 minutes before graft procurement	A 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.	During 5 minutes before graft procurement
Secondary	Spectral powers of central venous pressure corresponding to respiratory rate and heart rate during 5 minutes before the first dose of furosemide	A 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.	During 5 minutes before the first dose of furosemide
Secondary	Spectral powers of central venous pressure corresponding to respiratory rate and heart rate between 30 and 35 minutes after surgical incision	A 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.	Between 30 and 35 minutes after surgical incision
Secondary	Spectral power of central venous pressure corresponding to respiratory rate during 5 minutes before graft procurement	A 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.	During 5 minutes before graft procurement
Secondary	Spectral powers of central venous pressure corresponding to respiratory rate and heart rate during 5 minutes after administration of 6% hydroxyethyl starch	A 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.	During 5 minutes after administration of 6% hydroxyethyl starch
Secondary	Stroke volume variation during 5 minutes before the first dose of furosemide	The median of the values calculated at a 20-second interval	During 5 minutes before the first dose of furosemide
Secondary	Stroke volume index during 5 minutes before the first dose of furosemide	The median of the values calculated at a 20-second interval	During 5 minutes before the first dose of furosemide
Secondary	Cardiac index during 5 minutes before the first dose of furosemide	The median of the values calculated at a 20-second interval	During 5 minutes before the first dose of furosemide
Secondary	Stroke volume variation between 30 and 35 minutes after surgical incision	The median of the values calculated at a 20-second interval	Between 30 and 35 minutes after surgical incision
Secondary	Stroke volume index between 30 and 35 minutes after surgical incision	The median of the values calculated at a 20-second interval	Between 30 and 35 minutes after surgical incision
Secondary	Cardiac index between 30 and 35 minutes after surgical incision	The median of the values calculated at a 20-second interval	Between 30 and 35 minutes after surgical incision
Secondary	Stroke volume variation during 5 minutes before graft procurement	The median of the values calculated at a 20-second interval	During 5 minutes before graft procurement
Secondary	Stroke volume index during 5 minutes before graft procurement	The median of the values calculated at a 20-second interval	During 5 minutes before graft procurement
Secondary	Cardiac index during 5 minutes before graft procurement	The median of the values calculated at a 20-second interval	During 5 minutes before graft procurement
Secondary	Stroke volume variation during 5 minutes after administration of 6% hydroxyethyl starch	The median of the values calculated at a 20-second interval	During 5 minutes after administration of 6% hydroxyethyl starch
Secondary	Stroke volume index during 5 minutes after administration of 6% hydroxyethyl starch	The median of the values calculated at a 20-second interval	During 5 minutes after administration of 6% hydroxyethyl starch
Secondary	Cardiac index during 5 minutes after administration of 6% hydroxyethyl starch	The median of the values calculated at a 20-second interval	During 5 minutes after administration of 6% hydroxyethyl starch
Secondary	Total dose of furosemide	The total dose of furosemide used for the promotion of diuresis	At graft procurement
Secondary	Urine output at graft procurement	The total amount of urine output between the placement of urinary catheter and graft procurement	At graft procurement
Secondary	Total urine output at the end of surgery	The total amount of urine output at the end of surgery	At the end of surgery
Secondary	Intraoperative blood loss	Calculated 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	1 day after surgery