Clinical Trial: Cerebral Oximetry in Lower Body Negative Pressure

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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-
Sponsor: Oslo University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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).


Original Secondary Outcome: Same as current

Information By: Oslo University Hospital

Dates:
Date Received: October 26, 2015
Date Started: October 2015
Date Completion:
Last Updated: March 16, 2017
Last Verified: March 2017