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

No results posted yet for this study

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

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03516175 on ClinicalTrials.gov