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

Anesthesia Clinical Trial

— ATLANTIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04507581
• Other study ID #: 2020-01421
• Status: Completed
• Start date: July 30, 2020
• Est. completion date: October 19, 2021

Study information

• Verified date: October 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 19, 2021
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anesthesia
• Pulmonary Atelectasis

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Duration of radiological procedure.	Duration of radiological procedure.	minutes
Secondary	Duration of anaesthesia	Duration of anaesthesia	minutes