Detection of Hypovolemia Using Pleth Variability Index (PVI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lena Nilsson, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01456559
First received: October 16, 2011
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
Hypovolemia
Other: Lower body negative pressure (LBNP)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-invasive Detection of Mild Hypovolemia Using Pleth Variability Index (PVI) During Spontaneous Breathing

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Pleth Variability Index (PVI) [ Time Frame: Participants will be followed only during the experimental study, 3 hours. ] [ Designated as safety issue: No ]
    Primary endpoint: PVI at two different predefined levels of hypovolemia created by using lower negative body pressure, 40 and 15 mmHg, respectively.


Secondary Outcome Measures:
  • Pleth Variability Index (PVI) [ Time Frame: Participants will be followed only during the experiments, for 3 hours ] [ Designated as safety issue: No ]
    Correlation between PVI as an indication of hypovolemia measured simultaneously from two locations, ear lobe and finger.

  • SpHb [ Time Frame: Participants will be followed during the experiments, for 3 hours ] [ Designated as safety issue: No ]
    Non-invasive hemoglobin (SpHb) is followed during mild hypovolemia created by lower body negative pressure.


Enrollment: 14
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Lower body negative pressure (LBNP)

    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.

Detailed Description:

The subjects are placed supine on a bed. Non invasive equipment for recording pulse and blood pressure is placed on a finger on the right hand. From this equipment total peripheral resistance and cardiac output are recorded. A pulse oximeter for saturation, perfusion index and PVI is placed on a finger and on the ear lobe. Data are recorded in parallel from the finger and the ear lobe. In addition non invasive haemoglobin (Hb) is recorded from the pulse oximeter on the finger. The subjects breathe through a mask connected to a simple Y-connector with an inspiratory valve on one side and an expiratory valve on the other. A positive pressure valve is applied on the expiratory side. Tidal volume is measured on-line by a connector connected to a spirometer and the tidal volume is displayed to the subjects. Stroke volume, total peripheral resistance and cardiac output is measured using ultra sound via the jugular fossa.

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. Respiratory rate is not controlled. The order of the four series is randomized. Between the series a 20 minute period of rest is allowed to the subjects. This period is also necessary to restore steady state between provocations.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Subjects without any heart or lung disease

Exclusion Criteria:

  • Smoking
  • Drugs affecting circulatory or respiratory system
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456559

Locations
Sweden
Universitetssjukhuset
Linköping, Sweden, S-581 85
Anestesi- och operationskliniken, Universitetssjukhuset
Linköping, Sweden, SE-581 85
Sponsors and Collaborators
University Hospital, Linkoeping
Investigators
Principal Investigator: Lena Nilsson, MD, PhD Anestesi- och operationskliniken, Linköping Universtity Hospital, S-581 85 Linköping, Sweden
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lena Nilsson, MD, PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01456559     History of Changes
Other Study ID Numbers: Vers 2011-07-11
Study First Received: October 16, 2011
Last Updated: January 16, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
Hypovolemia
Lower body negative pressure
Photoplethysmography

Additional relevant MeSH terms:
Hypovolemia
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014