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Trial record 2 of 30 for:    atlantis lung

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

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ClinicalTrials.gov Identifier: NCT04507581
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Riva, University Hospital Inselspital, Berne

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

Condition or disease Intervention/treatment
Anesthesia 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).

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of Atelectasis Formation With Electrical Impedance Tomography During Anesthesia for MRI in Children
Actual Study Start Date : July 30, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung


Intervention Details:
  • 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).


Primary Outcome Measures :
  1. Changes in poorly ventilated lung areas at 2 Hours after intervention [ Time Frame: 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 :
  1. 2 min after Anesthesia induction [ Time Frame: 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.

  2. end of the radiological procedure. [ Time Frame: 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

  3. 2 minutes after the end of anaesthesia [ Time Frame: 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.

  4. Duration of radiological procedure. [ Time Frame: minutes ]
    Duration of radiological procedure.

  5. Duration of anaesthesia [ Time Frame: minutes ]
    Duration of anaesthesia



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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We will include paediatric patients undergoing radiological procedures requiring intravenous anaesthesia.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04507581


Contacts
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Contact: Thomas Riva, MD +41326325201 thomas.riva@insel.ch
Contact: Robert Greif, MD Robert.Greif@insel.ch

Locations
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Switzerland
University Hospital Bern Recruiting
Bern, Switzerland, 3010
Contact: Thomas Riva, MD    +41326325201    thomas.riva@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Thomas H Riva, MD University of Bern
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Responsible Party: Thomas Riva, Dr.med, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04507581    
Other Study ID Numbers: 2020-01421
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Riva, University Hospital Inselspital, Berne:
children
electrical impedance tomography
Additional relevant MeSH terms:
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Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs