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

• Sponsor: Szeged University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04857242
• Collaborator: Budapest University of Technology and Economics (Other), Hochschule Furtwangen University (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Death	Diagnostic Test: Apnea test, alveolar recruitment	N/A

Detailed Description

The aim of the study is to assess the eligibility of electrical impedance monitoring for the detection of possible spontaneous initiations of inspiration during apnea test in patients with suspected brain death. The study could contribute to the opening of new areas in the clinical use of the electrical impedance device. An additional aim is to observe the collapse and the reopening by recruitment manoeuvers of different pulmonary regions.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Electrical Impedance Tomography Measurements During Apnea Test in Patients With Suspected Brain Death
• Actual Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: apnea test, recruitment manoeuvre 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. Continuous administration of 6 L/min O2 flow via a catheter into the tracheal tube. 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. 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. Recruitment manoeuvre (PEEP 20 cmH2O, pressure control 20 cmH20 for 40 minutes) then set up of the initial ventilator parameters. Terminal arterial blood gas results and vital parameters 5 minutes following the end of the recruitment manoeuvre.

Diagnostic Test: Apnea test, alveolar recruitment; Alveolar recruitment following the phase of apnea testing

Outcome Measures

Primary Outcome Measures

1. detection of spontaneous inspiration [20 minutes]

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

Secondary Outcome Measures

1. Gas exchange [20 minutes]

   Change in arterial partial pressure of oxygen (PaO2) (mmHg) following alveolar recruitment performed after apnea testing

2. Dynamic compliance [20 minutes]

   Change in dynamic compliance (ml/cmH2O) following alveolar recruitment

3. End expiratory lung impedance [20 minutes]

   Change in end expiratory lung impedance (EELI) (%) following alveolar recruitment

4. Center of ventilation [20 minutes]

   Change in center of ventilation (%) following alveolar recruitment

5. Lung perfusion [20 minutes]

   Changes in lung perfusion during the apnea phase (%)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Szeged	Szeged		Hungary	6725

Sponsors and Collaborators

• Szeged University
• Budapest University of Technology and Economics
• Hochschule Furtwangen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Szeged University
• ClinicalTrials.gov Identifier: NCT04857242
• Other Study ID Numbers: apnEIT
• First Posted: Apr 23, 2021
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Szeged University: Apnea testing; Electrical Impedance Tomography
• Additional relevant MeSH terms: Brain Death; Death

Study Results

No Results Posted as of Feb 15, 2022