Pleth Variability Index and Hypotension

Hypotension Clinical Trial

Official title:

Hypotension Relationship With Pleth Variability Index In Hip Fracture Patients Who Underwent Spinal Anesthesia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02984956
• Other study ID #: ERZINCAN UNIVERSITY 4
• Status: Active, not recruiting
• Phase: N/A
• First received: December 4, 2016
• Last updated: December 6, 2016
• Start date: December 2016
• Est. completion date: November 2017

Study information

• Verified date: December 2016
• Source: Erzincan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Correct assessment of a patient's volume status is the most important goal for an anesthetist. However, most of the variables used for fluid response evaluation are invasive and technically challenging.Pulse oximeter is a non-invasive, standardized and widely used monitoring method in many countries. Our aim in this study is to investigate the usefulness of the noninvasive pleth variability index to predict hypotension in orthopedic hip fracture patients who underwent spinal anesthesia.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• over 65 years old

• Patients to undergo spinal anesthesia

Exclusion Criteria:

• Patients under 65 years old

• Patients to undergo general anesthesia or only sedation

• Patients with cardiac arrhythmia

• Patients with low ventricular ejection fraction

• Heart valve disease patients

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypotension
• Pleth Variability Index

Intervention

Device:
• pleth variability index

Locations

Country	Name	City	State
Turkey	Erzincan University	Erzincan

Sponsors (1)

Lead Sponsor	Collaborator
Erzincan University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

Cannesson M, Delannoy B, Morand A, Rosamel P, Attof Y, Bastien O, Lehot JJ. Does the Pleth variability index indicate the respiratory-induced variation in the plethysmogram and arterial pressure waveforms? Anesth Analg. 2008 Apr;106(4):1189-94, table of contents. doi: 10.1213/ane.0b013e318167ab1f. — View Citation

Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. — View Citation

Derichard A, Robin E, Tavernier B, Costecalde M, Fleyfel M, Onimus J, Lebuffe G, Chambon JP, Vallet B. Automated pulse pressure and stroke volume variations from radial artery: evaluation during major abdominal surgery. Br J Anaesth. 2009 Nov;103(5):678-84. doi: 10.1093/bja/aep267. — View Citation

Desebbe O, Boucau C, Farhat F, Bastien O, Lehot JJ, Cannesson M. The ability of pleth variability index to predict the hemodynamic effects of positive end-expiratory pressure in mechanically ventilated patients under general anesthesia. Anesth Analg. 2010 Mar 1;110(3):792-8. doi: 10.1213/ANE.0b013e3181cd6d06. — View Citation

Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. — View Citation

Kumar A, Anel R, Bunnell E, Habet K, Zanotti S, Marshall S, Neumann A, Ali A, Cheang M, Kavinsky C, Parrillo JE. Pulmonary artery occlusion pressure and central venous pressure fail to predict ventricular filling volume, cardiac performance, or the response to volume infusion in normal subjects. Crit Care Med. 2004 Mar;32(3):691-9. — View Citation

Osman D, Ridel C, Ray P, Monnet X, Anguel N, Richard C, Teboul JL. Cardiac filling pressures are not appropriate to predict hemodynamic response to volume challenge. Crit Care Med. 2007 Jan;35(1):64-8. — View Citation

Preisman S, Kogan S, Berkenstadt H, Perel A. Predicting fluid responsiveness in patients undergoing cardiac surgery: functional haemodynamic parameters including the Respiratory Systolic Variation Test and static preload indicators. Br J Anaesth. 2005 Dec;95(6):746-55. — View Citation

Solus-Biguenet H, Fleyfel M, Tavernier B, Kipnis E, Onimus J, Robin E, Lebuffe G, Decoene C, Pruvot FR, Vallet B. Non-invasive prediction of fluid responsiveness during major hepatic surgery. Br J Anaesth. 2006 Dec;97(6):808-16. — View Citation

Zimmermann M, Feibicke T, Keyl C, Prasser C, Moritz S, Graf BM, Wiesenack C. Accuracy of stroke volume variation compared with pleth variability index to predict fluid responsiveness in mechanically ventilated patients undergoing major surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. doi: 10.1097/EJA.0b013e328335fbd1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detecting pleth variability index-hypotension relationship		one year	Yes
Secondary	pleth variability index response to fluid management		one year	Yes
Secondary	Make a differential diagnosis of hypotension with pleth variability index		one year	Yes
Secondary	Correlation between arterial hemoglobin and pleth variability index hemoglobin		one year	Yes