Clinical trial NCT03516175: Pre-oxygenation With High-flow Nasal Cannula in Adults During Rapid Sequence Induction Anesthesia
Official title: Pre-oxygenation With High-flow Nasal Cannula in Comparison to Standard in Adults During Rapid Sequence Induction Anesthesia- a Prospective Randomized Non-blinded International Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Hypoxia
Surgery
Acute
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: St. George's Hospital, London
name: University College London Hospitals
name: Poole Hospital NHS Foundation Trust
First posted: 2018-05-04
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The number of patients that desaturates below 93% in SpO2 during pre oxygenation up to 1 minute after intubation
timeFrame: From start of anaesthesia until 1 minute after tracheal intubation, that is normally after 3-4 minutes after anaesthesia induction
Secondary outcomes:
measure: Lowest SpO2 during preoxygenation using THRIVE compared to traditional pre-oxygenation from time to first anesthetic drug given up to 1 minute after intubation.
timeFrame: From start of anaesthesia until 1 minute after tracheal intubation, that is normally after 3-4 minutes after anaesthesia induction
measure: 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?
timeFrame: At the first breath after tracheal intubation that is usually 2-4 minutes after induction of anaesthesia
measure: Level of end-tidal O2 in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?
timeFrame: At the first breath after tracheal intubation that is usually 2-4 minutes after induction of anaesthesia
measure: Incidence of gastric regurgitation between the groups?
timeFrame: From start of anaesthesia until 2 minutes after tracheal intubation, that is normally after 4-5 minutes after anaesthesia induction
measure: Difference in numbers of patients being ventilated between the two groups?
timeFrame: From start of anaesthesia until the patient is intubated, usually within 3-4 minutes
Other outcomes:
Locations:
city: Karlstad
country: Sweden
facility: Centralsjukhuset Karlstad
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: St Göran Hospital
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Bern
country: Switzerland
facility: University Hospital of Bern
Study officials:
affiliation: Karolinska University Hospital and Karolinska Institutet
name: Malin Jonsson Fagerlund
role: PRINCIPAL_INVESTIGATOR
References: