Spectral Analysis of Central Venous Pressure Waveform

NCT04733547 | Completed DMC

• 1 other identifier: CR-21-007
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Donor Hepatectomy; Central Venous Catheter; Hypovolemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Spectral powers of central venous pressure corresponding to respiratory rate and heart rate during 5 minutes before the first dose of furosemide

  During 5 minutes before the first dose of furosemide

• Spectral powers of central venous pressure corresponding to respiratory rate and heart rate between 30 and 35 minutes after surgical incision

  Between 30 and 35 minutes after surgical incision

• Spectral power of central venous pressure corresponding to respiratory rate during 5 minutes before graft procurement

  During 5 minutes before graft procurement

• Spectral powers of central venous pressure corresponding to respiratory rate and heart rate during 5 minutes after administration of 6% hydroxyethyl starch

  During 5 minutes after administration of 6% hydroxyethyl starch

• Stroke volume variation during 5 minutes before the first dose of furosemide

  During 5 minutes before the first dose of furosemide

Other Outcomes (20)

• Age

  On arrival at the operating room

• Sex

  On arrival at the operating room

• Height

  The day before surgery

Study Arms (1)

Donor hepatectomy

Live donors undergoing hepatectomy

Procedure: Placement of a central venous catheter; Device: Monitoring of central venous pressure; Drug: Furosemide-induced hypovolemia before graft procurement; Drug: Replacement of fluid loss after graft procurement; Device: Monitoring of stroke volume variation

Interventions

Placement of a central venous catheter PROCEDURE

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.

Donor hepatectomy

Monitoring of central venous pressure DEVICE

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.

Donor hepatectomy

Furosemide-induced hypovolemia before graft procurement DRUG

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.

Donor hepatectomy

Replacement of fluid loss after graft procurement DRUG

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.

Donor hepatectomy

Monitoring of stroke volume variation DEVICE

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.

Donor hepatectomy

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients are recruited from a tertiary university hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• JongHae Kim: lead

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Related 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.

  PMID: 24901895 BACKGROUND

• 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.

  PMID: 27070329 BACKGROUND

• 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.

  PMID: 29028929 BACKGROUND

• 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.

  PMID: 25862041 BACKGROUND

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonghae Kim, M.D.

  Daegu Catholic University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 2, 2021
• Study Start: February 22, 2021
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

KR (1)