Trans-nasal Humidified Rapid- Insufflation Ventilatory Exchange in Children Requiring Emergent Intubation
The aim of this study is to assess the effect of THRIVE as a method for prolonging apnoeic oxygenation during the emergency intubation of children to reduce the proportion adverse events (specifically, oxygen desaturation) and increase the proportion of first attempt success for endotracheal intubation.
Recruitment stats as @ 22/4/20
- Study commenced 09/05/2021
- Sample size: 960
- Current Overall Enrolment Total: 674
Sites currently recruiting as @ 22/4/20
- Queensland Children’s Hospital – ED & PICU
- Children’s Hospital at Westmead – PICU
- Gold Coast University Hospital – ED & PICU
- Monash Children’s Hospital – ED & PICU
- Perth Children’s Hospital – PICU
- Royal Children’s Hospital, Melbourne – PICU & NICU
- Townsville Hospital – ED & PICU
- Women’s and Children’s Hospital PICU
Planned to start recruitment in 2021
- Planned to start recruitment in 2021
- BC Children’s Hospital Vancouver – PICU
- University Children’s Hospital Zurich – PICU
1,780 children have been screen for inclusion into the KIDS THRIVE study and to date 674 have been randomised and consented. Of the enrolled children approximately 12% have been intubated in the ED, 81% in the PICU and 7% in the NICU. This study has been approved for consent to continue (delayed consent) due to the emergent nature of intubations. In 2020 a systematic, prioritized, risk-based approach to monitoring the KIDS THRIVE project was undertaken and centralised in depth source documentation verification and monitoring of the trial has now commenced.
The Kids THRIVE Trial Steering Committee (TSC) had complex discussions in March 2020 regarding the unfolding COVID-19 health crisis and the unique nature of the coronavirus infection and disease in children and recommended the study not be paused and that sites be allowed to develop their own local plan on how to manage the recruitment of patients. In order to support sites the protocol was amended to allow for verbal consent to be obtained by the research staff.
The KIDS THRIVE study received initial seed funding from the Emergency Medicine Foundation, and additional funding from the Thrasher Research Fund and the National Health and Medical Research Council.