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Cerebral Oximetry in Lower Body Negative Pressure

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03009305
Enrollment
20
Registered
2017-01-04
Start date
2015-10-31
Completion date
2017-03-31
Last updated
2017-03-17

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

Conditions

Hypovolemia

Brief summary

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.

Detailed description

20 healthy volunteers will be included. The study protocol consists of two parts. 1. 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). 2. 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.

Interventions

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

DEVICEContinuous positive airway pressure

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

PEP of 0, 5 and 10 cm H2O.

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
StO2 (tissue oxygen saturation).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

MeasureTime frameDescription
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.Association between MSFP and volume status.
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.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).

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026