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

NCT ID: NCT04507581

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-30
• Study Completion Date: 2024-10-30

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

Detailed Description

Eligible, children, with parental written informed consent, scheduled for a cerebral magnetic resonance image (MRI) will receive an intravenous anaesthesia using a Propofol infusion of 10 mg/kg/h. At the Bern Children's Hospital all children will be premedicated with Midazolam rectal/oral 0.5 mg/kg or Dexmedetomidine nasal 2 mcg/kg 20 minutes before the beginning of the procedure Eligible children will be prepared for procedure according to the local SOPs of the paediatric anaesthesia departments. Mandatory monitoring will consist of: SpO2, HR, NIBP. An iv-line for drugs injection will be placed.

Induction of anaesthesia: after iv-line placement a bolus of Propofol of 2 mg/kg followed by a continuous infusion of 10 mg/kg/h will be applied. Administration of low-flow oxygen for all children (0.3 l/kg/min) via Microstream® Smart CapnoLine® paediatric cannula (Philips Healthcare, Amsterdam, Netherlands). This cannula allows to measure the etCO2.

In case of extremely agitated child an inhalative induction may be performed. This technique represent the actual standard of care and is not associated with increased risks because of the study.

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).

Conditions

Anesthesia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

electrical impedance tomography during anaesthesia

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Thomas Riva

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas H Riva, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

University Hospital Bern

Bern, Canton of Bern, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 34902800 (View on PubMed)

Other Identifiers

2020-01421

Identifier Type: -

Identifier Source: org_study_id