Evaluation of Atelectasis Formation With Electrical Impedance Tomography During Anesthesia for MRI in Children (ATLANTIS)

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

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Other: electrical impedance tomography during 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).

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Exclusion criteria are necessity to intubate the child,
• contraindication for propofol administration,
• congenital heart or lung disease with oxygen
• dependency and high aspiration risk (requiring rapid sequence induction intubation).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
2 min after Anesthesia induction	Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT) 2 minutes after the end of induction, before the radiological procedure.	2 minutes after the end of anaesthesia induction
end of the radiological procedure.	Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT) at the end of the radiological procedure	2 minutes after the end of radiological procedure
2 minutes after the end of anaesthesia	Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT) 2 minutes after the end of anaesthesia, before the transport in PACU.	2 minutes after the end of anaesthesia, before the transport in Post Anaesthesia Care Unit
Duration of radiological procedure.	Duration of radiological procedure.	minutes
Duration of anaesthesia	Duration of anaesthesia	minutes

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Thomas H Riva, MD, University of Bern

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2020
• Primary Completion (ACTUAL): October 19, 2021
• Study Completion (ACTUAL): October 19, 2021

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 9, 2020
• First Posted (ACTUAL): August 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: children; electrical impedance tomography
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2020-01421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No