NCT03009305

Brief Summary

The study aims to describe hemodynamic effects of lower body negative pressure (LBNP).

  1. 1.If and how changes in cerebral oxygen saturation (StO2) measured by near infrared spectroscopy (NIRS) relate to changes in blood flow in the carotid arteries during progressive LBNP.
  2. 2.If and how mean systemic filling pressure (MSFP) can be measured by brief occlusion of blood flow to an arm and if this relates to LBNP-level.
  3. 3.If and how pulse pressure variations and photoplethysmographic amplitude variations during positive expiratory pressure (PEP) and continuous positive airway pressure (CPAP) relate to LBNP-level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2015

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

1.4 years

First QC Date

October 26, 2015

Last Update Submit

March 16, 2017

Conditions

Hypovolemia

Outcome Measures

Primary Outcomes (1)

  • StO2 (tissue oxygen saturation).

    Association between cerebral StO2 and flow in a. carotis interna.

    Approximatrly 30 min: From start LBNP (lower body negative pressure) exposure to 5 min after end LBNP.

Secondary Outcomes (2)

  • MSFP, mean systemic filling pressure (arm venous pressure during vascular occlusion).

    Approximatrly 30 min: From start LBNP (lower body negative pressure) exposure to 5 min after end LBNP.

  • Dynamic variables and PEP (positive expiratory pressure)/CPAP (continuous positive airway pressure)

    Approximatrly 30 min: From start LBNP (lower body negative pressure) exposure to 5 min after end LBNP.

Study Arms (1)

Lower body negative pressure

EXPERIMENTAL

Single-arm, lower body negative pressure, continuous positive airway pressure, positive expiratory pressure.

Other: Lower body negative pressureDevice: Continuous positive airway pressureDevice: Positive expiratory pressure

Interventions

Lower body negative pressureOTHER

Model of hypovolemia: Lower body negative pressure down to -80 mmHg (maximum).

Lower body negative pressure
Continuous positive airway pressureDEVICE

CPAP of 0, 5 and 10 cm water (H2O).

Also known as: CPAP
Lower body negative pressure
Positive expiratory pressureDEVICE

PEP of 0, 5 and 10 cm H2O.

Also known as: PEP
Lower body negative pressure

Eligibility Criteria

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

You may qualify if:

  • Healthy volunteer (informed consent)

You may not qualify if:

  • Disease/physical condition limiting normal physical activity or requiring medication (except allergies/contraceptives)
  • History of syncope (except with obvious vasovagal etiology)
  • Cardiac arrhythmia
  • Pregnancy
  • Skin infections in the elbow crease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0450, Norway

Location

MeSH Terms

Conditions

Hypovolemia

Interventions

Lower Body Negative PressureContinuous Positive Airway PressurePositive-Pressure Respiration

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DecompressionTherapeuticsRespiration, ArtificialAirway ManagementRespiratory Therapy

Study Officials

  • Svein Aslak Landsverk, M.D., PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 26, 2015

First Posted

January 4, 2017

Study Start

October 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 17, 2017

Record last verified: 2017-03

Locations

NO(1)