NCT02549482

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

Same day

First QC Date

September 10, 2015

Last Update Submit

September 12, 2015

Conditions

Hypovolemia

Keywords

Central volume deficitHead-up tiltSystolic pressure variation

Outcome Measures

Primary Outcomes (1)

  • Systolic pressure variation (SPV)

    Relative difference between systolic blood pressure during inspiration and expiration. Meassured in percent.

    Two minutes

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27515038DERIVED

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 10, 2015

First Posted

September 15, 2015

Study Start

August 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

September 15, 2015

Record last verified: 2015-09