HypovolemiaNCT02549482
Detecting a Volume Deficit During Spontaneous Breathing
A study testing Respiratory resistor in people with Hypovolemia, run by Aalborg University Hospital.
Trial summary
13 healthy volunteers (4 females) were tilted 45° head-up while breathing through a facemask fitted with an inspiratory and expiratory resistor. A brachial arterial catheter was used to measure blood pressure and thus systolic pressure variation and pulse contour analysis determined stroke volume and thereby cardiac… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypovolemia
- What is being tested?
- Respiratory resistor
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Aug 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- pregnancy
- lactating
- any regular or acute use of medicine
About this study
Official title: Detecting a Central Volume Deficit in Spontaneous Breathing Healthy Volunteers by Systolic Blood Pressure Variation
13 healthy volunteers (4 females) were tilted 45° head-up while breathing through a facemask fitted with an inspiratory and expiratory resistor. A brachial arterial catheter was used to measure blood pressure and thus systolic pressure variation and pulse contour analysis determined stroke volume and thereby cardiac output in order to detect a central volume deficit.
Read the detailed description
Thirteen healthy volunteers (4 women) at an age of 25 years (range 18-36) were recruited through www.forsøgsperson.dk.
The volunteers were placed on a tilt table and provided with a facemask with an opening of 30-33 mm. A Hook ring was fitted with an inspiratory resistor, an expiratory resistor, a combination of the two resistors, or with no resistance and each resistor provides a 7.5 cmH2O threshold resistance. Each resistor was applied for two minutes with variables obtained in the last minute. The table was then tilted 45° head-up to accumulating blood in the legs and therefore a reduction in the central blood volume. Conversely, 20° head-down tilt was used to expand the central blood volume. For each volunteer measurements with the four respiratory interventions was randomized, whereas the tilt table position was in fixed order: supine, head-up tilt, and head-down tilt.
Three-lead ECG recorded heart rate. A 20 G arterial catheter was placed in the brachial artery of the non-dominant arm and connected to a transducer for reading of blood pressure and stroke volume variation (Vigileo-Flotrac™, version 1.07, Edwards Lifesciences, Nyon, Switzerland). Also SV and CO variation and the arterial pressure curve were recorded for subsequent determination of arterial pressure variations. Additionally, a catheter was placed via a brachial vein to the superior caval vein for recording of central venous pressure and SvO2. While the subjects were breathing spontaneously, the respiratory rate was measured by capnography and peripheral oxygen saturation by fingerprobe.
Variation in the arterial pulse pressure (PPV) was 100 x ((PPmax - PPmin) / ((PPmax + PPmin)/2)), where PPmax and PPmin is the maximal and minimal difference between systolic and diastolic pressure during the respiratory cycle, respectively. By the same formula systolic pressure variation (SPV) was calculated.
- Conditions
- Hypovolemia
- Being tested
- Respiratory resistor
- Keywords
- Central volume deficit, Head-up tilt, Systolic pressure variation
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory resistorOther
The volunteers are breathing through the four respiratory resistors (inspiratory, expiratory, combined in- and expiratory and no resistor) in order to increase the intrathoracic pressure svings
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic pressure variation (SPV)
Relative difference between systolic blood pressure during inspiration and expiration. Meassured in percent.
Measured: Two minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startAug 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Michael Dahl, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549482
- Sponsor's protocol ID
- H-4-2010-110-SPV
- Status last verified
- Sep 2015
- First submitted
- 10 Sep 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dahl M, Hayes C, Steen Rasmussen B, Larsson A, Secher NH. Can a central blood volume deficit be detected by systolic pressure variation during spontaneous breathing? BMC Anesthesiol. 2016 Aug 11;16(1):58. doi: 10.1186/s12871-016-0224-z.
PubMed 27515038
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting a Central Volume Deficit in Spontaneous Breathing Healthy Volunteers by Systolic Blood Pressure Variation
- ClinicalTrials.gov ID
- NCT02549482
- Acronym / sponsor ID
- H-4-2010-110-SPV
- Conditions
- Hypovolemia
- Keywords
- Central volume deficit, Head-up tilt, Systolic pressure variation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Aug 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Sep 2015 (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.
13 healthy volunteers (4 females) were tilted 45° head-up while breathing through a facemask fitted with an inspiratory and expiratory resistor. A brachial arterial catheter was used to measure blood pressure and thus systolic pressure variation and pulse contour analysis determined stroke volume and thereby cardiac output in order to detect a central volume deficit.
Detailed description
Thirteen healthy volunteers (4 women) at an age of 25 years (range 18-36) were recruited through www.forsøgsperson.dk.
The volunteers were placed on a tilt table and provided with a facemask with an opening of 30-33 mm. A Hook ring was fitted with an inspiratory resistor, an expiratory resistor, a combination of the two resistors, or with no resistance and each resistor provides a 7.5 cmH2O threshold resistance. Each resistor was applied for two minutes with variables obtained in the last minute. The table was then tilted 45° head-up to accumulating blood in the legs and therefore a reduction in the central blood volume. Conversely, 20° head-down tilt was used to expand the central blood volume. For each volunteer measurements with the four respiratory interventions was randomized, whereas the tilt table position was in fixed order: supine, head-up tilt, and head-down tilt.
Three-lead ECG recorded heart rate. A 20 G arterial catheter was placed in the brachial artery of the non-dominant arm and connected to a transducer for reading of blood pressure and stroke volume variation (Vigileo-Flotrac™, version 1.07, Edwards Lifesciences, Nyon, Switzerland). Also SV and CO variation and the arterial pressure curve were recorded for subsequent determination of arterial pressure variations. Additionally, a catheter was placed via a brachial vein to the superior caval vein for recording of central venous pressure and SvO2. While the subjects were breathing spontaneously, the respiratory rate was measured by capnography and peripheral oxygen saturation by fingerprobe.
Variation in the arterial pulse pressure (PPV) was 100 x ((PPmax - PPmin) / ((PPmax + PPmin)/2)), where PPmax and PPmin is the maximal and minimal difference between systolic and diastolic pressure during the respiratory cycle, respectively. By the same formula systolic pressure variation (SPV) was calculated.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (3 listed)
- pregnancy
- lactating
- any regular or acute use of medicine
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 |
|---|---|---|
| Respiratory resistorThe volunteers are breathing through the four respiratory resistors (inspiratory, expiratory, combined in- and expiratory and no resistor) in order to increase the intrathoracic pressure svings | Other | – |
Primary outcome
Systolic pressure variation (SPV)
Time frame: Two minutes
Relative difference between systolic blood pressure during inspiration and expiration. Meassured in percent.
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 15 Sep 2015.
- Derived from this study: PubMed 27515038Dahl M, Hayes C, Steen Rasmussen B, Larsson A, Secher NH. Can a central blood volume deficit be detected by systolic pressure variation during spontaneous breathing? BMC Anesthesiol. 2016 Aug 11;16(1):58. doi: 10.1186/s12871-016-0224-z.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory resistor in people with Hypovolemia, run by Aalborg University Hospital.
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 3 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 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Systolic pressure variation (SPV) (time frame: Two minutes). 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 NCT02549482, which also lists 1 linked publication.
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 15 Sep 2015.