Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-12 @ 10:57 AM
Study NCT ID:
NCT03009305
Status:
COMPLETED
Last Update Posted:
2017-03-17
First Post:
2015-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Oximetry in Lower Body Negative Pressure
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
Cerebral Oxygen Saturation, Mean Systemic Filling Pressure and Haemodynamic Effects of PEP and CPAP in Lower Body Negative Pressure
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: