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Detecting a Volume Deficit During Spontaneous Breathing

Detecting a Central Volume Deficit in Spontaneous Breathing Healthy Volunteers by Systolic Blood Pressure Variation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02549482
Enrollment
13
Registered
2015-09-15
Start date
2011-08-31
Completion date
2011-08-31
Last updated
2015-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypovolemia

Keywords

Central volume deficit, Head-up tilt, Systolic pressure variation

Brief 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 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.

Interventions

OTHERRespiratory resistor

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

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
Aalborg University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* healthy volunteers

Exclusion criteria

* pregnancy * lactating * any regular or acute use of medicine

Design outcomes

Primary

MeasureTime frameDescription
Systolic pressure variation (SPV)Two minutesRelative difference between systolic blood pressure during inspiration and expiration. Meassured in percent.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026