HypovolemiaNCT01456559
Detection of Hypovolemia Using Pleth Variability Index (PVI)
An observational study of Hypovolemia, run by University Hospital, Linkoeping at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypovolemia
- What is being tested?
- Lower body negative pressure (LBNP)
- How many people
- 14 participants
- Where
- 2 sitesSweden
- Study dates
- Oct 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy subjects between 18-30 years old without any medications affecting circulatory or respiratory system
Who may be able to join
- Subjects without any heart or lung disease
Who cannot join
- Smoking
- Drugs affecting circulatory or respiratory system
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Universitetssjukhuset
Linköping, S-581 85
Anestesi- och operationskliniken, Universitetssjukhuset
Linköping, SE-581 85
About this study
Official title: Non-invasive Detection of Mild Hypovolemia Using Pleth Variability Index (PVI) During Spontaneous Breathing
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
Read the 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.
- Conditions
- Hypovolemia
- Being tested
- Lower body negative pressure (LBNP)
- Keywords
- Hypovolemia, Lower body negative pressure, Photoplethysmography
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed only during the experimental study, 3 hours.
Secondary outcomes (2)
Pleth Variability Index (PVI)
Correlation between PVI as an indication of hypovolemia measured simultaneously from two locations, ear lobe and finger.
Measured: Participants will be followed only during the experiments, for 3 hours
SpHb
Non-invasive hemoglobin (SpHb) is followed during mild hypovolemia created by lower body negative pressure.
Measured: Participants will be followed during the experiments, for 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena Nilsson, University Hospital, Linkoeping
- Investigators
- Lena Nilsson, MD, PhD, Principal investigator, Anestesi- och operationskliniken, Linköping Universtity Hospital, S-581 85 Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456559
- Sponsor's protocol ID
- Vers 2011-07-11
- Status last verified
- Jan 2013
- First submitted
- 16 Oct 2011
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18522935Cooke 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.
PubMed 15016789Keller 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.
PubMed 18325089Shelley 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.
PubMed 16861419Nilsson 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.
PubMed 17711563Nilsson 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.
PubMed 23839074
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Detection of Mild Hypovolemia Using Pleth Variability Index (PVI) During Spontaneous Breathing
- ClinicalTrials.gov ID
- NCT01456559
- Acronym / sponsor ID
- Vers 2011-07-11
- Conditions
- Hypovolemia
- Keywords
- Hypovolemia, Lower body negative pressure, Photoplethysmography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subjects between 18-30 years old without any medications affecting circulatory or respiratory system
Key inclusion criteria (1 listed)
- Subjects without any heart or lung disease
Key exclusion criteria (2 listed)
- Smoking
- Drugs affecting circulatory or respiratory system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
Pleth Variability Index (PVI)
Time frame: Participants will be followed only during the experimental study, 3 hours.
Primary endpoint: PVI at two different predefined levels of hypovolemia created by using lower negative body pressure, 40 and 15 mmHg, respectively.
2 secondary outcomes
Pleth Variability Index (PVI)
Time frame: Participants will be followed only during the experiments, for 3 hours
SpHb
Time frame: Participants will be followed during the experiments, for 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
- Background: PubMed 18522935Cannesson 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.
- Background: PubMed 15016789Cooke 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.
- Background: PubMed 18325089Keller 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.
- Background: PubMed 16861419Shelley 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.
- Background: PubMed 17711563Nilsson 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.
- Derived from this study: PubMed 23839074Nilsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena Nilsson, MD, PhD principal investigator
Anestesi- och operationskliniken, Linköping Universtity Hospital, S-581 85 Linköping, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypovolemia, run by University Hospital, Linkoeping at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pleth Variability Index (PVI) (time frame: Participants will be followed only during the experimental study, 3 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01456559, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.