IsoCOMFORT study
Research type
Research Study
Full title
A Randomised Active-controlled Study to Compare Efficacy and Safety of Inhaled Isoflurane Delivered by the AnaConDa-S (Anaesthetic Conserving Device) to Intravenous Midazolam for Sedation in Mechanically Ventilated Paediatric Patients 3 to 17 (Less than 18) Years Old
IRAS ID
1004579
Contact name
Peter Sackey
Contact email
Sponsor organisation
Sedana Medical AB
Eudract number
2020-000578-31
ISRCTN Number
ISRCTN12741394
Clinicaltrials.gov Identifier
Research summary
Mechanical ventilation is a method which helps patients who can’t breathe spontaneously, whereby a machine called a ventilator is used to help move air in and out of the lungs.
Mechanically ventilated patients often need to be sedated to ensure comfort. Sedation is a reduced degree of consciousness or artificial sleep, induced by medication. Mechanically ventilated patients in the the intensive care unit (ICU) are sometimes sedated with the same anaesthesia-medication as used for surgery but at a lower dose and often over a longer time.
Today, only a medication called midazolam, which is administered over the venes, is approved for sedation of mechanically ventilated children. However, studies in adults have shown that so-called inhalation anaesthetics such as isoflurane (anaesthetic in the form of gas delivered via the lungs) can be used as an alternative to intravenous substances for sedation in ICUs. A prerequisite for this is an additional device connected to the ventilator, called AnaConDa-S, which allows the inhaled anaesthetics to be mixed with breathing air.
Studies in adults have shown that inhaling isoflurane for sedation is equally good and shows promising advantages over standard intravenous sedation, such as shorter wake-up times, better tolerated, fewer side effects and better ability to maintain the desired level of sedation.
There is quite a number of reports and smaller trials in which isoflurane or another inhalation anaesthetic were administered safely and with great success. The purpose of this study is to collect data on a larger scale to determine if inhaled isoflurane has the same level of effect and safety in children as intravenous midazolam. This is necessary, since isoflurane has so far only been approved for anaesthesia in surgery, but not for sedation in ICUs.
Approximately 160 children (aged 3-17 years) will participate in this study that is being conducted at approximately 20 different ICUs in Europe.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0036
Date of REC Opinion
22 Mar 2022
REC opinion
Further Information Favourable Opinion