Pre-oxygenation With High-flow Nasal Cannula in Adults During Rapid Sequence Induction Anesthesia
NCT03516175 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350
Last updated 2020-12-10
Summary
It has been demonstrated that Transnasal Humidified Rapid Insufflation Ventilatory Exchange used during preoxygenation for emergency surgery is at least equally effective as preoxygenation compared to standard tight fitting mask. Data from a recent study indicates that Transnasal Humidified Rapid Insufflation Ventilatory Exchange might decrease the risk of clinically relevant desaturation below 93% of arterial oxygen saturation. The limitations with our previous study is that it was done only during office hours (Mon-Friday 8 am to 4 pm) and that the power to detect the occurrence of desaturation was too low.
Based on the above, the aim is now to conduct a clinical international multicenter study 24/7 with 450 patients and with a simplified protocol that allows the study to be done 24/7. This study is done with the aim of evaluation before implementing this novel technique of preoxygenation into clinical practice.
The general purpose of this project is to compare a the preoxygenation technique based on Transnasal Humidified Rapid Insufflation Ventilatory Exchange with traditional preoxygenation with a tight fitting mask during rapid sequence induction (RSI) intubation in patients undergoing emergency surgery.
Conditions
- Anesthesia
- Hypoxia
- Surgery
- Acute
Interventions
- DEVICE
-
High flow transnasal oxygen
High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange
- DEVICE
-
Pre oxygenation using tight fitting facemask
100% oxygen via a tight fitting facemask
Sponsors & Collaborators
-
St. George's Hospital, London
collaborator OTHER -
University College London Hospitals
collaborator OTHER -
Poole Hospital NHS Foundation Trust
collaborator OTHER -
Karolinska University Hospital
lead OTHER
Principal Investigators
-
Malin Jonsson Fagerlund · Karolinska University Hospital and Karolinska Institutet
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-21
- Primary Completion
- 2020-10-28
- Completion
- 2020-10-28
Countries
- Sweden
- Switzerland
Study Locations
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