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Apnea Tests as the Methods of Brain Death Diagnosis. (DiagBD)

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ClinicalTrials.gov Identifier: NCT03281993
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Joanna Sołek-Pastuszka, Pomeranian Medical University Szczecin

Brief Summary:
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.

Condition or disease Intervention/treatment
Brain Death Apnea Pupillary Anomaly Other: CPAP AT

Detailed Description:

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).


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Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Alternative Apnea Test as the Method of Brain Death Diagnosis .
Actual Study Start Date : June 25, 2015
Actual Primary Completion Date : June 25, 2015
Actual Study Completion Date : June 25, 2017

Group/Cohort Intervention/treatment
CPAP-AT
After 2 hours from I-AT was performed the alternative AT by CPAP ventilation mode. Before CPAP-AT and 10 minutes after blood samples for arterial blood gases (ABG) were collected. If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%, CPAP-AT was aborterd.
Other: CPAP AT
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 Name: change type of ventylation




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intubated adult ICU patients at the Intensive Care Unit of the Department of Anaesthesia and Intensive Care teaching hospital at the Pomeranian Medical University in Szczecin during Brain Death diagnosis
Criteria

Inclusion Criteria:

  • brain death diagnosis

Exclusion Criteria:

  • no

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281993


Sponsors and Collaborators
Pomeranian Medical University Szczecin
Investigators
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Principal Investigator: Joanna Pastuszka, MD PhD Pomeranian Medical University

Publications:
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Responsible Party: Joanna Sołek-Pastuszka, MD PhD, Pomeranian Medical University Szczecin
ClinicalTrials.gov Identifier: NCT03281993     History of Changes
Other Study ID Numbers: KB-0012/116/13
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joanna Sołek-Pastuszka, Pomeranian Medical University Szczecin:
apnea test, brain death, pupillometry
Additional relevant MeSH terms:
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Apnea
Brain Death
Pupil Disorders
Death
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Eye Diseases