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Completed

NCT Number: NCT03009305

Cerebral Oximetry in Lower Body Negative Pressure

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

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. 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. 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.

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Key information

Conditions

Hypovolemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0450, Norway

About this study

20 healthy volunteers will be included. The study protocol consists of two parts.

  • LBNP is applied stepwise (20 mmHg increments). At each LBNP-level, after 2 min stabilization, blood flow in internal and external carotid arteries is measured. Thereafter, MSFP is measured. LBNP is applied to -80 mmHg, but terminated sooner if the subject experiences signs of decompensation.

Changes in cerebral StO2 will be related to relative changes in blood flow in the carotid arteries. After these measurements, blood flow to one arm will be occluded for 30 s. Venous pressure measured in an antecubital vein approximates MSFP. This will be related to volume status (LBNP-level and stroke volume reduction).

  • LBNP is applied stepwise (20 mmHg increments). At each LBNP-level, after 2 min stabilization, PEP and CPAP are applied at 0, 5 and 10 cmH20. LBNP is applied to -80 mmHg, but terminated sooner if the subject experiences signs of decompensation.

Flow in carotid arteries is measured by ultrasound/Doppler. Skin blood flow in the forehead measured by laser Doppler flowmetry and transcutaneous oxygen saturation.

If possible, blood flow velocity in a. cerebri media will be measured by transcranial Doppler.

Central venous pressure will be approximated by measuring pressure in the left subclavian vein ("half-way" catheter).

Cardiac stroke volume will be measured by suprasternal Doppler. Expiratory carbon dioxide (CO2) will be measured and recorded. Acral skin photoplethysmography performed using proprietary and custom-made photoplethysmographs.

Arterial blood pressure approximated by finger volume-clamp method.

The measurements above will be used for analyses of possible physiological mechanisms and post-hoc analyses.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteer (informed consent)

Exclusion criteria

  • 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

Treatment and study plan

Lower body negative pressure

Other

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

Continuous Positive Airway Pressure

Device

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

Other names: CPAP

Positive expiratory pressure

Device

PEP of 0, 5 and 10 cm H2O.

Other names: PEP

Primary outcomes

  1. StO2 (tissue oxygen saturation).

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

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

Secondary outcomes

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

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

    Association between MSFP and volume status.

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

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

    Association between dynamic variables during PEP/CPAP and volume status. Dynamic variables (variations in arterial pressure and photoplethysmographic waveforms with respiration) are calculated during with PEP and CPAP during hypovolemia (lower body negative pressure).

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Cerebral Oxygen Saturation, Mean Systemic Filling Pressure and Haemodynamic Effects of PEP and CPAP in Lower Body Negative Pressure

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 4, 2017
Registry last updated
Mar 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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