Apnea Tests as the Methods of Brain Death Diagnosis.

NCT ID: NCT03281993

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-25
• Study Completion Date: 2017-06-25

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.

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).

Conditions

Brain Death; Apnea; Pupillary Anomaly

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

CPAP AT

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

change type of ventylation

Eligibility Criteria

Inclusion Criteria

• brain death diagnosis

Exclusion Criteria

• no

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pomeranian Medical University Szczecin

OTHER

Sponsor Role: lead

Responsible Party

Joanna Sołek-Pastuszka

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joanna Pastuszka, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Pomeranian Medical University

References

Solek-Pastuszka J, Sawicki M, Iwanczuk W, Bohatyrewicz R. Ventilator-Delivered Continuous Positive Airway Pressure for Apnea Test in the Diagnosis of Brain Death in Patient With Extremely Poor Baseline Lung Function-Case Report. Transplant Proc. 2016 Sep;48(7):2471-2472. doi: 10.1016/j.transproceed.2016.02.089.

Reference Type: BACKGROUND

PMID: 27742325 (View on PubMed)

Saucha W, Solek-Pastuszka J, Bohatyrewicz R, Knapik P. Apnea test in the determination of brain death in patients treated with extracorporeal membrane oxygenation (ECMO). Anaesthesiol Intensive Ther. 2015;47(4):368-71. doi: 10.5603/AIT.2015.0051.

Reference Type: BACKGROUND

PMID: 26401745 (View on PubMed)

Solek-Pastuszka J, Saucha W, Iwanczuk W, Bohatyrewicz R. Evolution of apnoea test in brain death diagnostics. Anaesthesiol Intensive Ther. 2015;47(4):363-7. doi: 10.5603/AIT.2015.0050.

Reference Type: BACKGROUND

PMID: 26401744 (View on PubMed)

Other Identifiers

KB-0012/116/13

Identifier Type: -

Identifier Source: org_study_id