Monitoring of regional ventilation distribution during flexible bronchoscopy using electrical impedance tomography (FlexBrEIT)

Monitoring of regional ventilation distribution during flexible bronchoscopy using electrical impedance tomography (FlexBrEIT) - FlexBREIT study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039766

Enrollment

Registered

2026-03-27

Start date

2025-07-15

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J80 J96.1 Z93.0 J18.9

Interventions

Group 1: As part of flexible tracheobronchoscopies (TB), which are performed electively in mechanically ventilated pediatric patients or in pediatric patients electively admitted to the intensive care

thereafter (at T4), EIT measurement is terminated. Parallel data collection: In addition to epidemiological data (first name, last name, sex, gestational age at birth, birth weight, primary diagnosis,

Eligibility

Sex/Gender

All

Age

0 Years to 18 Years

Inclusion criteria

Inclusion criteria: All patients requiring long-term invasive ventilation and needing flexible tracheostomy under sedation, or 2) short-term mechanical ventilation (sedation with a laryngeal mask) as part of a planned routine tracheostomy, are eligible for inclusion in the study.

Exclusion criteria

Exclusion criteria: 1) Patients receiving palliative care 2) Lack of parental consent 3) Contraindications to performing the EIT measurement as per the approval (e.g., an implanted pacemaker) or the inability to perform the EIT measurement on the chest due to wound dressings or implanted drains.

Design outcomes

Primary

Measure	Time frame
The demonstration of a significant change in regional ventilation distribution (non-normally distributed dataset) between timepoints before (T0), and after (T2) flexible TB will be evaluated using EIT based on predefined indices. Significant changes are expected for: Center of Ventilation (horizontal): significant change in median CoV from T0 to T1, from T1 to T2, and from T0 to T2 Center of Ventilation (vertical): significant change in median CoV from T0 to T1, from T1 to T2, and from T0 to T2 Global Inhomogeneity Index: significant change in median GI index from T0 to T1, from T1 to T2, and from T0 to T2 End-expiratory lung impedance (EELI): significant change in median EELI from T0 to T1, from T1 to T2, and from T0 to T2	—

Measure

Time frame

The demonstration of a significant change in regional ventilation distribution (non-normally distributed dataset) between timepoints before (T0), and after (T2) flexible TB will be evaluated using EIT based on predefined indices. Significant changes are expected for: Center of Ventilation (horizontal): significant change in median CoV from T0 to T1, from T1 to T2, and from T0 to T2 Center of Ventilation (vertical): significant change in median CoV from T0 to T1, from T1 to T2, and from T0 to T2 Global Inhomogeneity Index: significant change in median GI index from T0 to T1, from T1 to T2, and from T0 to T2 End-expiratory lung impedance (EELI): significant change in median EELI from T0 to T1, from T1 to T2, and from T0 to T2

—

Secondary

Measure	Time frame
1) Detection of a significant decrease in regional ventilation distribution during bronchoscopy (time point T1) (CoV, GI, EELI)	—

Countries

Germany

Contacts

Public ContactLukas Schröder

Uniklinik Bonn, Klinik für Neonatologie und Pädiatrische Intensivmedizin

lukas.schroeder@ukbonn.de+49 228 28737834

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026