Cerebral Oximetry in Lower Body Negative Pressure

Hypovolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009305
• Other study ID #: 2015/3995
• Status: Completed
• Phase: N/A
• First received: October 26, 2015
• Last updated: March 16, 2017
• Start date: October 2015
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypovolemia

Intervention

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).
• Positive expiratory pressure
PEP of 0, 5 and 10 cm H2O.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.