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

NCT03516175 | Completed

• 1 other identifier: PRIOR2
• Study Type: interventional
• Target: 350
• Locations: 2 countries
• Sites: 6

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.

Conditions

Anesthesia; Hypoxia; Surgery; Acute

Outcome Measures

Primary Outcomes (1)

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

  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

Secondary Outcomes (5)

• 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

• 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 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

• 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

• 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

Study Arms (2)

Tight fitting mask

ACTIVE COMPARATOR

Pre oxygenation with tight facemask with 100% oxygen

Device: Pre oxygenation using tight fitting facemask

High flow nasal oxygen

EXPERIMENTAL

High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange is used for pre oxygenation

Device: High flow transnasal oxygen

Interventions

High flow transnasal oxygen DEVICE

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

Also known as: Transnasal Humidified Rapid Insufflation Ventilatory Exchange

High flow nasal oxygen

Pre oxygenation using tight fitting facemask DEVICE

100% oxygen via a tight fitting facemask

Tight fitting mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (6)

Centralsjukhuset Karlstad

Karlstad, Sweden

Location

Linköping University Hospital

Linköping, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

St Göran Hospital

Stockholm, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

University Hospital of Bern

Bern, Switzerland

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Malin Jonsson Fagerlund

  Karolinska University Hospital and Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Associate Professor

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: May 4, 2018
• Study Start: March 21, 2018
• Primary Completion: October 28, 2020
• Study Completion: October 28, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

CH (1); SE (5)