Acute, Anesthesia, Hypoxia, Surgery
Conditions
Brief 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.
Interventions
DEVICEHigh flow transnasal oxygen
High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange
DEVICEPre oxygenation using tight fitting facemask
100% oxygen via a tight fitting facemask
Sponsors
St. George's Hospital, London
University College London Hospitals
Poole Hospital NHS Foundation Trust
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult, \>18 years old 2. Emergency intubation where Rapid Sequence Induction is indicated 3. Capable of understanding the study information and signing the written consent.
Exclusion criteria
1. Body Mass Index \>35 2. Pregnancy 3. Dependency on non-invasive ventilation to maintain oxygen saturation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients that desaturates below 93% in SpO2 during pre oxygenation up to 1 minute after intubation | From start of anaesthesia until 1 minute after tracheal intubation, that is normally after 3-4 minutes after anaesthesia induction | The number of patients that desaturates below 93% in SpO2 during pre oxygenation up to 1 minute after intubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lowest SpO2 during preoxygenation using THRIVE compared to traditional pre-oxygenation from time to first anesthetic drug given up to 1 minute after intubation. | From start of anaesthesia until 1 minute after tracheal intubation, that is normally after 3-4 minutes after anaesthesia induction | Lowest SpO2 during preoxygenation using THRIVE compared to traditional pre-oxygenation from time to first anesthetic drug given up to 1 minute after intubation. |
| Level of end-tidal carbon dioxide in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation? | At the first breath after tracheal intubation that is usually 2-4 minutes after induction of anaesthesia | Level of end-tidal carbon dioxide in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation? |
| Level of end-tidal O2 in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation? | At the first breath after tracheal intubation that is usually 2-4 minutes after induction of anaesthesia | Level of end-tidal O2 in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation? |
| Incidence of gastric regurgitation between the groups? | From start of anaesthesia until 2 minutes after tracheal intubation, that is normally after 4-5 minutes after anaesthesia induction | Incidence of gastric regurgitation between the groups? |
| Difference in numbers of patients being ventilated between the two groups? | From start of anaesthesia until the patient is intubated, usually within 3-4 minutes | Is there a difference in the number of patients that was ventilated before intubation between the two study groups? |
Countries
Sweden, Switzerland
Outcome results
None listed