Cerebral Oximetry in Lower Body Negative Pressure
Primary Purpose
Hypovolemia
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lower body negative pressure
Continuous positive airway pressure
Positive expiratory pressure
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypovolemia
Eligibility Criteria
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
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lower body negative pressure
Arm Description
Single-arm, lower body negative pressure, continuous positive airway pressure, positive expiratory pressure.
Outcomes
Primary Outcome Measures
StO2 (tissue oxygen saturation).
Association between cerebral StO2 and flow in a. carotis interna.
Secondary Outcome Measures
MSFP, mean systemic filling pressure (arm venous pressure during vascular occlusion).
Association between MSFP and volume status.
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).
Full Information
NCT ID
NCT03009305
First Posted
October 26, 2015
Last Updated
March 16, 2017
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03009305
Brief Title
Cerebral Oximetry in Lower Body Negative Pressure
Official Title
Cerebral Oxygen Saturation, Mean Systemic Filling Pressure and Haemodynamic Effects of PEP and CPAP in Lower Body Negative Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to describe hemodynamic effects of lower body negative pressure (LBNP).
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.
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lower body negative pressure
Arm Type
Experimental
Arm Description
Single-arm, lower body negative pressure, continuous positive airway pressure, positive expiratory pressure.
Intervention Type
Other
Intervention Name(s)
Lower body negative pressure
Intervention Description
Model of hypovolemia: Lower body negative pressure down to -80 mmHg (maximum).
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure
Other Intervention Name(s)
CPAP
Intervention Description
CPAP of 0, 5 and 10 cm water (H2O).
Intervention Type
Device
Intervention Name(s)
Positive expiratory pressure
Other Intervention Name(s)
PEP
Intervention Description
PEP of 0, 5 and 10 cm H2O.
Primary Outcome Measure Information:
Title
StO2 (tissue oxygen saturation).
Description
Association between cerebral StO2 and flow in a. carotis interna.
Time Frame
Approximatrly 30 min: From start LBNP (lower body negative pressure) exposure to 5 min after end LBNP.
Secondary Outcome Measure Information:
Title
MSFP, mean systemic filling pressure (arm venous pressure during vascular occlusion).
Description
Association between MSFP and volume status.
Time Frame
Approximatrly 30 min: From start LBNP (lower body negative pressure) exposure to 5 min after end LBNP.
Title
Dynamic variables and PEP (positive expiratory pressure)/CPAP (continuous positive airway pressure)
Description
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).
Time Frame
Approximatrly 30 min: From start LBNP (lower body negative pressure) exposure to 5 min after end LBNP.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svein Aslak Landsverk, M.D., PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0450
Country
Norway
12. IPD Sharing Statement
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Cerebral Oximetry in Lower Body Negative Pressure
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