Clinical trial NCT04507581: Evaluation of Atelectasis Formation with Electrical Impedance Tomography During Anesthesia for MRI in Children
Official title: Evaluation of Atelectasis Formation with Electrical Impedance Tomography During Anesthesia for MRI in Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anesthesia
Keywords: children
electrical impedance tomography
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will include paediatric patients undergoing radiological procedures requiring intravenous anaesthesia.

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).

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:

* 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).

Primary outcomes:
measure: Changes in poorly ventilated lung areas at 2 Hours after intervention
timeFrame: 2 hours
Secondary outcomes:
measure: 2 min after Anesthesia induction
timeFrame: 2 minutes after the end of anaesthesia induction
measure: end of the radiological procedure.
timeFrame: 2 minutes after the end of radiological procedure
measure: 2 minutes after the end of anaesthesia
timeFrame: 2 minutes after the end of anaesthesia, before the transport in Post Anaesthesia Care Unit
measure: Duration of radiological procedure.
timeFrame: minutes
measure: Duration of anaesthesia
timeFrame: minutes
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: University of Bern
name: Thomas H Riva, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.