Comparing Pleth Variability Index (PVI) Measurements at Different Sensing Locations

NCT02124551 | Completed DMC

• 1 other identifier: UCIANES05
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the suitability of the ear and forehead as a better site for measure of fluid responsiveness.

Conditions

Fluid Imbalance

Keywords

Goal-directed fluid therapy

Outcome Measures

Primary Outcomes (1)

• PVI measurement of fluid responsiveness

  The primary outcome is to test the ability of PVI recorded at the finger and at the ear to predict fluid responsiveness.

  Intra-operative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be patients who undergo any form of surgery, where he/she is mechanically ventilated, preferably cases that require arterial line placement, use of cardiac output measurement, and where fluid administration will occur perioperatively.

You may qualify if:

• years of age or older
• Undergo any type of surgeries under general anesthesia in UCI Medical Center
• Mechanically ventilated during surgery
• Arterial line placement is preferred but not required
• Agree to sign the consent and HIPAA forms

You may not qualify if:

• Less than 18 years of age
• Pregnant women
• Refused to sign the consent and HIPAA forms
• Receive vasoactive medication prior to surgery
• Has these conditions: hypotension, hypothyroidism, moderate or poorly controlled hypertension, chronic poorly-controlled diabetes, heart failure patients, and patients with active airway flow obstruction, left ventricular dysfunction, intra-cardiac shunts, right ventricular dysfunction, atrial fibrillation, arrhythmias
• patients with surgeries at or around site of sensor placement
• Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the study

Sponsors & Collaborators

• University of California, Irvine: lead
• Masimo Corporation: collaborator

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (7)

• Cannesson M, Besnard C, Durand PG, Bohe J, Jacques D. Relation between respiratory variations in pulse oximetry plethysmographic waveform amplitude and arterial pulse pressure in ventilated patients. Crit Care. 2005 Oct 5;9(5):R562-8. doi: 10.1186/cc3799. Epub 2005 Aug 23.

  PMID: 16277719 BACKGROUND

• Feissel M, Teboul JL, Merlani P, Badie J, Faller JP, Bendjelid K. Plethysmographic dynamic indices predict fluid responsiveness in septic ventilated patients. Intensive Care Med. 2007 Jun;33(6):993-9. doi: 10.1007/s00134-007-0602-6. Epub 2007 Mar 29.

  PMID: 17393139 BACKGROUND

• Cannesson M, Attof Y, Rosamel P, Desebbe O, Joseph P, Metton O, Bastien O, Lehot JJ. Respiratory variations in pulse oximetry plethysmographic waveform amplitude to predict fluid responsiveness in the operating room. Anesthesiology. 2007 Jun;106(6):1105-11. doi: 10.1097/01.anes.0000267593.72744.20.

  PMID: 17525584 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

• Hood JA, Wilson RJ. Pleth variability index to predict fluid responsiveness in colorectal surgery. Anesth Analg. 2011 Nov;113(5):1058-63. doi: 10.1213/ANE.0b013e31822c10cd. Epub 2011 Sep 30.

  PMID: 21965349 BACKGROUND

• Shelley KH, Jablonka DH, Awad AA, Stout RG, Rezkanna H, Silverman DG. What is the best site for measuring the effect of ventilation on the pulse oximeter waveform? Anesth Analg. 2006 Aug;103(2):372-7, table of contents. doi: 10.1213/01.ane.0000222477.67637.17.

  PMID: 16861419 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

Study Officials

• Maxime Cannesson, PhD

  UC Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 28, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

US (1)