Effect of THRIVE During Apneic Oxygenation in General Anesthesia on Biomarkers

NCT ID: NCT03453294

Last Updated: 2020-10-14

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2018-11-01

Brief Summary

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Oxygenation with high-flow nasal cannula with 100% oxygen have now been evaluated in a number of studies and the data are convincing. The THRIVE technique is able to oxygenate patients safely and vital parameters has been shown to be stable. But it is of great importance to evaluate this new concept regarding other potential negative physiological aspects such as biological stress response detected by blood-bourne biomarkers before implementing it into clinical practice.

Detailed Description

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Conditions

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Anesthesia Oxygen Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Apnoeic oxygenation using THRIVE

Oxygenation by apnoea oxygenation using THRIVE

Group Type EXPERIMENTAL

Apnoeic oxygenation using THRIVE

Intervention Type DEVICE

Apnoeic oxygenation using THRIVE

Endotracheal intubation and mechanical ventilation

Ventilation and oxygenation by an endotracheal tub and mechanical ventilation

Group Type ACTIVE_COMPARATOR

Endotracheal intubation and mechanical ventilation

Intervention Type DEVICE

Endotracheal intubation and mechanical ventilation

Interventions

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Apnoeic oxygenation using THRIVE

Apnoeic oxygenation using THRIVE

Intervention Type DEVICE

Endotracheal intubation and mechanical ventilation

Endotracheal intubation and mechanical ventilation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adults, \>18 years old.
2. Laryngeal-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery).
3. Capable of understanding the study information and sign the written consent.

Exclusion Criteria

1. American Society of Anaesthesiologist severity score \>2
2. New York Heart Association score \>2
3. Pacemaker or ICD.
4. Body Mass Index \>35
5. Pregnancy
6. Manifest cardiac failure or coronary disease
7. Severe gastrointestinal reflux.
8. Neuromuscular disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Malin Jonsson Fagerlund

Senior Consultant, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Bio-THRIVE

Identifier Type: -

Identifier Source: org_study_id

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