Implementation of Apnoea Test for Patients With Suspected Brain Death

Brain Death Clinical Trial

Official title:

Implementation of Apnoea Test for Patients With Suspected Brain Death (IMAPing SUBDEP)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06359119
• Other study ID #: IMAPing SUBDEP
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged
• Contact: Bakos Péter
• Phone: +36207752886
• Email: imaping.subdep[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study consists of a survey created for intensive care physicians regarding their current practice of the implementation of apnoea test for patients with suspected brain death.

Description:

Although the apnoea test is part of nearly all protocols for determining brain death; implementation significantly differs among intensive care physicians according to national-level acts, national society protocols or local protocols.

This cross-sectional study is based on an international, web-based questionnaire created for intensive care physicians, consisting of 25 questions in English.

The survey will provide a current state of the practice of apnoea testing in patients with suspected brain death. The results can support the determination of future acts to standardize the apnoea test process.

The given answers are anonymous. The e-mail address of the respondent is not recorded. Answers are treated solely for scientific purposes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Physicians working in intensive care units

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Brain Death
• Death

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged	Veszprém County Ferenc Csolnoky Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Continuous positive airway pressure (CPAP)	If a CPAP system is used during apnoea test, what is the value of positive end-expiratory pressure (PEEP) in H2Ocm.	last 1 year
Primary	Number of apnoea tests	How much apnoea test is required for brain death determination.	last 1 year
Primary	Timeframe between apnoea tests	If more than 1 apnoeae test is reuired for brain death determination, how many hours should elapse between the two tests.	last 1 year
Primary	Preoxygenation	For how long (in minutes) the patient is preoxygenated before the apnoea test.	last 1 year
Primary	Baseline arterial carbon dioxide (CO2) level	What is the required arterial partial CO2 pressure (PaCO2) before apnoea testing, confirmed by arterial blood gas measurement?	Last 1 year
Secondary	Detection of possible spontaneous breath movements	To determine if any observation method other than visualisation by the observer is used to determine possible spontaneous breath movements during the apnoea test.	last 1 year
Secondary	Satisfaction with current practice	Surveying the satisfaction of physicians with current practice regarding the method of the detection of spontaneous breath movements on a 4 grade scale (1 - non-reliable to 4 - very reliable).	last 1 year