Evaluation of Lung Atelectasis During Apneic Oxygenation Using THRIVE in Adults During Laryngeal Surgery.

NCT ID: NCT03458091

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

2020-10-10

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 lung atelectasis and inflammatory stress response before implementing it into clinical practice.

Detailed Description

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Conditions

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Anesthesia

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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Intubation

The patients will be intubated and ventilated

Group Type ACTIVE_COMPARATOR

Endotracheal intubation

Intervention Type DEVICE

Ventilation during the procedure is governed by an endotracheal tube in the trachea and mechanical ventilation

THRIVE

The patients will be oxygenated during apnea using THRIVE

Group Type EXPERIMENTAL

THRIVE

Intervention Type DEVICE

Oxygenation during apnea using transversal humidified oxygen

Interventions

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THRIVE

Oxygenation during apnea using transversal humidified oxygen

Intervention Type DEVICE

Endotracheal intubation

Ventilation during the procedure is governed by an endotracheal tube in the trachea and mechanical ventilation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adults, \>18 years old.
2. ENT-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. ASA\>2
2. NYHA \>2
3. Pacemaker or ICD.
4. BMI \>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

Principal Investigators

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Malin Jonsson Fagerlund

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital and Karolinska Institutet

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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A-THRIVE

Identifier Type: -

Identifier Source: org_study_id

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