Electrical Impedance Tomography Measurements During Apnea Test in Patients With Suspected Brain Death

NCT04857242 | Completed

• 1 other identifier: apnEIT
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Apnea testing is the final decisive examination in the strictly regulated process of brain death assessment. There is no standardized method found in the literature for apnea testing except for the inspection of possible spontaneous chest movements. In addition, the test itself lasts for several minutes leading to the collapse of the lungs. Electrical impedance tomography (EIT) is a non-invasive, real-time monitoring technique, which is suitable for detecting changes in lung volumes during ventilation. With its help, one can examine the spontaneous initiation of inspiration, the development of atelectasis and the reopening of collapsed regions by mechanical ventilation. Furthermore, the apnea test provides for analysing the effect of changes in pulmonary perfusion on impedance in the absence of noise generated by ventilation.

Conditions

Brain Death

Keywords

Apnea testing; Electrical Impedance Tomography

Outcome Measures

Primary Outcomes (1)

• detection of spontaneous inspiration

  Detection of absolute changes in impedance using EIT during apnea test, which may refer to spontaneous initiations of inspiration

  20 minutes

Secondary Outcomes (5)

• Gas exchange

  20 minutes

• Dynamic compliance

  20 minutes

• End expiratory lung impedance

  20 minutes

• Center of ventilation

  20 minutes

• Lung perfusion

  20 minutes

Study Arms (1)

apnea test, recruitment manoeuvre

EXPERIMENTAL

1. Continuous electric impedance tomography (EIT) recording. Recording of initial vital parameters and arterial blood gas results. Adjusment of PaCO2 between 38-42 mmHg, 10 minutes of preoxygenation with FiO2 of 1.0 then disconnection of the patient from the ventilator. 2. Continuous administration of 6 L/min O2 flow via a catheter into the tracheal tube. 3. Arterial blood gas sampling and recording of vital parameters in every second minutes. Detection of any spontaneous respiratory movement by the apnoe test investigator or by EIT signals. 4. Reconnection with respirator if there is any sign of spontaneous breathing effort or if there is no spontaneous breathing effort and the PaCO2 is over 60 mmHg. Recording of vital parameters. 5. Recruitment manoeuvre (PEEP 20 cmH2O, pressure control 20 cmH20 for 40 minutes) then set up of the initial ventilator parameters. 6. Terminal arterial blood gas results and vital parameters 5 minutes following the end of the recruitment manoeuvre.

Diagnostic Test: Apnea test, alveolar recruitment

Interventions

Apnea test, alveolar recruitment DIAGNOSTIC_TEST

Alveolar recruitment following the phase of apnea testing

apnea test, recruitment manoeuvre

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with suspected brain death undergoing apnea test for detecting the absence of spontaneous breathing

You may not qualify if:

• age under 18
• pregnancy
• pulmonectomy, lung resection in the past medical history
• clinically end stage chronic obstructive pulmonary disease (COPD)
• severe hemodynamic instability (vasopressor refractory shock)
• severe bullous emphysema and/or spontaneous pneumothorax in the past medical history
• chest drainage in situ due to pneumothorax and/or bronchopleural fistula

Sponsors & Collaborators

• Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged: lead
• Budapest University of Technology and Economics: collaborator
• Hochschule Furtwangen University: collaborator
• Szeged University: collaborator

Study Sites (1)

University of Szeged

Szeged, 6725, Hungary

Location

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 23, 2021
• Study Start: April 1, 2021
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)