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

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.

Study Overview

• Status: Completed
• Conditions: Hypovolemia
• Intervention / Treatment: Other: Lower body negative pressure; Device: Continuous positive airway pressure; Device: Positive expiratory pressure

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0450
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lower body negative pressure; Single-arm, lower body negative pressure, continuous positive airway pressure, positive expiratory pressure.	Other: Lower body negative pressure; Model of hypovolemia: Lower body negative pressure down to -80 mmHg (maximum).; Device: Continuous positive airway pressure; CPAP of 0, 5 and 10 cm water (H2O).; Other Names: CPAP; Device: Positive expiratory pressure; PEP of 0, 5 and 10 cm H2O.; Other Names: PEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MSFP, mean systemic filling pressure (arm venous pressure during vascular occlusion).	Association between MSFP and volume status.	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)	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).	Approximatrly 30 min: From start LBNP (lower body negative pressure) exposure to 5 min after end LBNP.

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Svein Aslak Landsverk, M.D., PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: December 30, 2016
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia
• Other Study ID Numbers: 2015/3995