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

NCT ID: NCT03516175

Last Updated: 2020-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-21

Study Completion Date

2020-10-28

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia Hypoxia Surgery Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tight fitting mask

Pre oxygenation with tight facemask with 100% oxygen

Group Type ACTIVE_COMPARATOR

Pre oxygenation using tight fitting facemask

Intervention Type DEVICE

100% oxygen via a tight fitting facemask

High flow nasal oxygen

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

Group Type EXPERIMENTAL

High flow transnasal oxygen

Intervention Type DEVICE

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

Interventions

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High flow transnasal oxygen

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

Intervention Type DEVICE

Pre oxygenation using tight fitting facemask

100% oxygen via a tight fitting facemask

Intervention Type DEVICE

Other Intervention Names

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Transnasal Humidified Rapid Insufflation Ventilatory Exchange

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. George's Hospital, London

OTHER

Sponsor Role collaborator

University College London Hospitals

OTHER

Sponsor Role collaborator

Poole Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Malin Jonsson Fagerlund

Senior Consultant, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Malin Jonsson Fagerlund

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital and Karolinska Institutet

Locations

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Centralsjukhuset Karlstad

Karlstad, , Sweden

Site Status

Linköping University Hospital

Linköping, , Sweden

Site Status

Karolinska University Hospital

Stockholm, , Sweden

Site Status

St Göran Hospital

Stockholm, , Sweden

Site Status

Södersjukhuset

Stockholm, , Sweden

Site Status

University Hospital of Bern

Bern, , Switzerland

Site Status

Countries

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Sweden Switzerland

Other Identifiers

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PRIOR2

Identifier Type: -

Identifier Source: org_study_id