Detection of Hypovolemia Using Pleth Variability Index (PVI)

NCT01456559 | Completed

• 1 other identifier: Vers 2011-07-11
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose with the planned study is to study Pleth Variability Index (PVI) as a non invasive indicator for mild hypovolemia during spontaneous breathing in healthy subjects. Lower body negative pressure (LBNP), a well established technique is used to create defined levels of hypovolemia. Primary hypothesis: By applying a breathing resistance (positive end expiratory pressure PEEP) to spontaneous breathing, the respiratory synchronous variation in the pulse oximeter signal (PVI) is enhanced and enables PVI to detect and grade the level of mild hypovolemia. Secondary hypothesis: 1) When tidal volume is increased, the respiratory synchronous variation in the pulse oximeter signal (PVI) will also increase. 2) The earlobe is superior to the finger in detecting PVI 3) Hemoglobin (Hb), detected non invasively by pulse oximetry, is not affected by hypovolemia created by LBNP

Conditions

Hypovolemia

Keywords

Hypovolemia; Lower body negative pressure; Photoplethysmography

Outcome Measures

Primary Outcomes (1)

• Pleth Variability Index (PVI)

  Primary endpoint: PVI at two different predefined levels of hypovolemia created by using lower negative body pressure, 40 and 15 mmHg, respectively.

  Participants will be followed only during the experimental study, 3 hours.

Secondary Outcomes (2)

• Pleth Variability Index (PVI)

  Participants will be followed only during the experiments, for 3 hours

• SpHb

  Participants will be followed during the experiments, for 3 hours

Interventions

Lower body negative pressure (LBNP) OTHER

The purpose with the planned study is to study pleth variability index (PVI) as a non invasive indicator for mild hypovolemia during spontaneous breathing in healthy subjects. Lower body negative pressure (LBNP), a well established technique, is used to create defined levels of hypovolemia. Baseline data are recorded with the subjects in the supine position breathing with normal tidal volume without PEEP and without LBNP applied. Data are then recorded with LBNP applied in two steps (40 and 15 mmHg). Recordings are continued 5 minutes after releasing the negative pressure. Data are collected in total in four different series; normal tidal volume without PEEP; normal tidal volume with PEEP 5cm H2O; three doubled tidal volume without PEEP; three doubled tidal volume with PEEP 5 cm H20.

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects between 18-30 years old without any medications affecting circulatory or respiratory system

You may qualify if:

• Subjects without any heart or lung disease

You may not qualify if:

• Smoking
• Drugs affecting circulatory or respiratory system

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (2)

Universitetssjukhuset

Linköping, S-581 85, Sweden

Location

Anestesi- och operationskliniken, Universitetssjukhuset

Linköping, SE-581 85, Sweden

Location

Related Publications (6)

• 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

• Cooke WH, Ryan KL, Convertino VA. Lower body negative pressure as a model to study progression to acute hemorrhagic shock in humans. J Appl Physiol (1985). 2004 Apr;96(4):1249-61. doi: 10.1152/japplphysiol.01155.2003.

  PMID: 15016789 BACKGROUND

• Keller G, Cassar E, Desebbe O, Lehot JJ, Cannesson M. Ability of pleth variability index to detect hemodynamic changes induced by passive leg raising in spontaneously breathing volunteers. Crit Care. 2008;12(2):R37. doi: 10.1186/cc6822. Epub 2008 Mar 6.

  PMID: 18325089 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

• Nilsson L, Goscinski T, Kalman S, Lindberg LG, Johansson A. Combined photoplethysmographic monitoring of respiration rate and pulse: a comparison between different measurement sites in spontaneously breathing subjects. Acta Anaesthesiol Scand. 2007 Oct;51(9):1250-7. doi: 10.1111/j.1399-6576.2007.01375.x. Epub 2007 Aug 15.

  PMID: 17711563 BACKGROUND

• Nilsson LM, Lindenberger DM, Hahn RG. The effect of positive end-expiratory pressure and tripled tidal volume on pleth variability index during hypovolaemia in conscious subjects: a volunteer study. Eur J Anaesthesiol. 2013 Nov;30(11):671-7. doi: 10.1097/EJA.0b013e32836394c0.

  PMID: 23839074 DERIVED

MeSH Terms

Conditions

Hypovolemia

Interventions

Lower Body Negative Pressure

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Decompression; Therapeutics

Study Officials

• Lena Nilsson, MD, PhD

  Anestesi- och operationskliniken, Linköping Universtity Hospital, S-581 85 Linköping, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 16, 2011
• First Posted: October 20, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

SE (2)