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Completed

NCT Number: NCT03516175

Pre-oxygenation With High-flow Nasal Cannula in Adults During Rapid Sequence Induction Anesthesia

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.

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Key information

Conditions

Anesthesia Acute Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centralsjukhuset Karlstad, Karlstad, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult, >18 years old
  • Emergency intubation where Rapid Sequence Induction is indicated
  • Capable of understanding the study information and signing the written consent.

Exclusion criteria

  • Body Mass Index >35
  • Pregnancy
  • Dependency on non-invasive ventilation to maintain oxygen saturation

Treatment and study plan

High flow transnasal oxygen

Device

High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange

Other names: Transnasal Humidified Rapid Insufflation Ventilatory Exchange

Pre oxygenation using tight fitting facemask

Device

100% oxygen via a tight fitting facemask

Primary outcomes

  1. The number of patients that desaturates below 93% in SpO2 during pre oxygenation up to 1 minute after intubation

    Time frame: 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 outcomes

  1. Lowest SpO2 during preoxygenation using THRIVE compared to traditional pre-oxygenation from time to first anesthetic drug given up to 1 minute after intubation.

    Time frame: 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.

  2. 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?

    Time frame: 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?

  3. Level of end-tidal O2 in the first breath after intubation with Transnasal Humidified Rapid Insufflation Ventilatory Exchange oxygenation compared with traditional pre-oxygenation?

    Time frame: 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?

  4. Incidence of gastric regurgitation between the groups?

    Time frame: 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?

  5. Difference in numbers of patients being ventilated between the two groups?

    Time frame: 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?

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Poole Hospital NHS Foundation Trust
  • St. George's Hospital, London
  • University College London Hospitals

Registry information

Official study 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

Acronym: PRIOR2

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 4, 2018
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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