Apnea Tests as the Methods of Brain Death Diagnosis.

Apnea test (AT) is the most important clinical test performed usually at the end of brain death (BD) diagnosis procedure. Traditional insufflation apnea test (I-AT) cannot be completed in patients with extremely compromised lung function due to rapid blood desaturation and circulatory disturbances. Therefore the investigators decided to verify alternative AT options such as continuous positive airway pressure apnea test (CPAP-AT) in patients with good and poor baseline oxygenation, before implementing them in currently reviewed Polish BD criteria.

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Key information

Conditions

Brain Death Apnea Brain Diseases Central Nervous System Diseases Coma Consciousness Disorders Death Eye Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Pupil Disorders Pupillary Anomaly Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Apnea test (AT) is one of the most important examination during the diagnosis of brain death. It is usually performed at the end of each series of clinical examinations during diagnostic process. The most popular standard insufflation apnea test (I-AT) may be potentially harmful. It may cause some serious complications including pneumothorax, severe hypoxemia, hemodynamic instability and even cardiac arrest. Therefore, the investigators decided to analyze apnea test in CPAP option (CPAP-AT) as a new tool. For safety of the study the investigators analyzed a method after BD diagnosis.

Methods:

I-AT and hypoventilation with 100 % oxygen (if needed) were performed according to Polish guidelines. Two hours after BD diagnosis was performed extra apnea test in CPAP option (CPAP-AT). Before CPAP-AT the patients were ventilated 100% oxygen. After then the ventilator settings were changed to CPAP mode with PEEP 10 cm H2O, PS 0 cm H2O, FiO2 1,0, flow 6L/min. Emergency apnea ventilation was turned off. At the beginning of CPAP mode and 10 minutes after, blood samples for arterial blood gases (ABG) were collected. If were observed rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborted and study was finished.

During routine diagnosis of brain death, pupillary dilation after a neck flexion was observed in one case. Therefore, the investigators decided to use a pupillometer during brain death examination to find out how pupils react after a neck flexion and how often it happens.

Pupil measurements were taken immediately after the diagnosis of brain death. The measurements of pupil diameter were taken twice: A - before neck flexion; B - after neck flexion. We used pupillometer: AlgiScan (Equip Medkey BV).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

brain death diagnosis

Exclusion criteria

Treatment and study plan

CPAP AT

Other

If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%; the CPAP apnea test (CPAP-AT) test was aborted.

Other names: change type of ventylation

Primary outcomes

Change from baseline arterial blood gases (ABG) during CPAP-AT

Time frame: 10 minutes

After 2 hours from I-AT was performed the alternative AT by CPAP ventilation mode. Before CPAP-AT the patients were ventilated 100% oxygen. After then the ventilator parameters were modified to: 0 H2O of pressure support (PS), 10 cm H2O of PEEP, 6l/min of O2 flow and 0.2 l/min of sensitivity. Before the test and 10 minutes after then was taken blood probe to ABG and type of ventilation change to pretest settings. The test is considered valid if there is no respiratory activity despite the rise of PaCO2 above 60mmHg and over 20mmHg above the baseline. If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborterd.

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Registry information

Official study title

Alternative Apnea Test as the Method of Brain Death Diagnosis .

Acronym: DiagBD

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2017
First posted: Sep 13, 2017
Registry last updated: Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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