Evaluation of Atelectasis Formation with Electrical Impedance Tomography During Anesthesia for MRI in Children

NCT04507581 | Terminated

• 1 other identifier: 2020-01421
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates under controlled conditions the variation of poorly ventilated lung units (silent spaces) in children between 1 and 6 years of age measured by electrical impedance tomography during intravenous anaesthesia in a day-hospital setting and before discharge to help further raise safety standards in paediatric anaesthesia

Conditions

Anesthesia

Keywords

children; electrical impedance tomography

Outcome Measures

Primary Outcomes (1)

• Changes in poorly ventilated lung areas at 2 Hours after intervention

  Changes in poorly ventilated lung areas (silent spaces) by using electrical impedance tomography (EIT) 2 hours after the end of anaesthesia before discharge at home, which will help quantify the degree of atelectasis

  2 hours

Secondary Outcomes (5)

• 2 min after Anesthesia induction

  2 minutes after the end of anaesthesia induction

• end of the radiological procedure.

  2 minutes after the end of radiological procedure

• 2 minutes after the end of anaesthesia

  2 minutes after the end of anaesthesia, before the transport in Post Anaesthesia Care Unit

• Duration of radiological procedure.

  minutes

• Duration of anaesthesia

  minutes

Interventions

electrical impedance tomography during anaesthesia OTHER

Before induction of the anaesthesia, before the radiological procedure when the induction is terminated, after the termination of the radiological procedure, before transport to the Post anaesthesia Care Unite (PACU), and before the discharge from the PACU after 2 hours of monitoring ventilation distribution changes by thoracic electrical impedance tomography are measured (each measurement will last 1 min). For this, resulting potential differences are measured, and impedance distribution sampled at 30 Hz will be calculated by an automated linearized Newton-Raphson reconstruction algorithm (9). Relative change in poorly ventilated lung regions (silent spaces) and end-expiratory lung impedance (EELI) and measures of ventilation inhomogeneity such as the global inhomogeneity index will be calculated as described previously, using customised software (Matlab R2013a, The MathWorks, Nattick, Massachusetts, USA)(10-12).

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

We will include paediatric patients undergoing radiological procedures requiring intravenous anaesthesia.

You may qualify if:

• ASA physical status 1 to 3,
• to 6 years of age with legal guardians providing written informed consent.

You may not qualify if:

• contraindication for propofol administration,
• congenital heart or lung disease with oxygen
• dependency and high aspiration risk (requiring rapid sequence induction intubation).

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (1)

• Riva T, Pascolo F, Huber M, Theiler L, Greif R, Disma N, Fuchs A, Berger-Estilita J, Riedel T. Evaluation of atelectasis using electrical impedance tomography during procedural deep sedation for MRI in small children: A prospective observational trial. J Clin Anesth. 2022 May;77:110626. doi: 10.1016/j.jclinane.2021.110626. Epub 2021 Dec 10.

  PMID: 34902800 DERIVED

Study Officials

• Thomas H Riva, MD

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 11, 2020
• Study Start: July 30, 2020
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)