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

Terminated

• Conditions: Anesthesia

• Registration Number: NCT04507581
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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).

Study Timeline

• Study Start: 2020-07-30
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-09
• Study First Posted: 2020-08-11
• Status Verified: 2024-10
• Primary Completion: 2024-10-30
• Study Completion: 2024-10-30
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in poorly ventilated lung areas at 2 Hours after intervention	2 hours	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

Secondary Outcome Measures

Name	Time	Method
Duration of anaesthesia	minutes	Duration of anaesthesia
2 minutes after the end of anaesthesia	2 minutes after the end of anaesthesia, before the transport in Post Anaesthesia Care Unit	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 min after Anesthesia induction	2 minutes after the end of anaesthesia 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.
end of the radiological procedure.	2 minutes after the end of 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
Duration of radiological procedure.	minutes	Duration of radiological procedure.

Trial Locations

Locations (1)

University Hospital Bern; 🇨🇭 Bern, Switzerland