Pleth Variability Index and Hypotension

NCT02984956 | Unknown

• 1 other identifier: ERZINCAN UNIVERSITY 4
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypotension; Pleth Variability Index

Keywords

Hypotension; Pleth variability index; Hip Fracture; Spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• Detecting pleth variability index-hypotension relationship

  one year

Secondary Outcomes (3)

• pleth variability index response to fluid management

  one year

• Make a differential diagnosis of hypotension with pleth variability index

  one year

• Correlation between arterial hemoglobin and pleth variability index hemoglobin

  one year

Interventions

pleth variability index DEVICE

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who underwent spinal anesthesia for hip fracture

You may qualify if:

• over 65 years old
• Patients to undergo spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Erzincan University: lead

Study Sites (1)

Erzincan University

Erzincan, Turkey (Türkiye)

Location

Related Publications (10)

• 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. doi: 10.1097/01.ccm.0000114996.68110.c9.

  PMID: 15090949 BACKGROUND

• 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. doi: 10.1097/01.CCM.0000249851.94101.4F.

  PMID: 17080001 BACKGROUND

• 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. doi: 10.1093/bja/aei262.

  PMID: 16286349 BACKGROUND

• 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. Epub 2008 Jun 2.

  PMID: 18522935 BACKGROUND

• 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. Epub 2009 Sep 29.

  PMID: 19797246 BACKGROUND

• 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. doi: 10.1093/bja/ael250. Epub 2006 Sep 16.

  PMID: 16980709 BACKGROUND

• 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.

  PMID: 18349191 BACKGROUND

• 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.

  PMID: 20035228 BACKGROUND

• 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. Epub 2010 Aug 12.

  PMID: 20705785 BACKGROUND

• 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.

  PMID: 20185658 BACKGROUND

MeSH Terms

Conditions

Hypotension; Hip Fractures

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist. prof.

Study Record Dates

• First Submitted: December 4, 2016
• First Posted: December 7, 2016
• Study Start: December 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 8, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)