Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy

NCT ID: NCT03976167

Last Updated: 2019-06-10

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

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-10

Study Completion Date

2019-02-28

Brief Summary

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Randomized controled trial to compare oxygen desaturation during fiberoptic bronchoscopy using oxygen administered with nasal prongs and high flow nasal cannula. Drops in oxygen saturation are frequent during bronchoscopy and limit the procedure compromising patient security. The investigator's aim is to contribute to select better way of oxygen administration which could prevent desaturations during bronchoscopy in children.

Detailed Description

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Conditions

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Respiratory Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Common nasal cannula

Oxygen administration up to 4 liters according defined protocol

Group Type ACTIVE_COMPARATOR

Oxygen administration with Common nasal cannula

Intervention Type DEVICE

Oxygen administration during elective flexible bronchoscopy in children with high flow nasal cannula with inspired oxygen fraction 1.

High flow nasal cannula

Oxygen administered with high flow nasal cannula according child weight and protocol designed for this study

Group Type EXPERIMENTAL

Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel

Intervention Type DEVICE

Interventions

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Oxygen administration with Common nasal cannula

Oxygen administration during elective flexible bronchoscopy in children with high flow nasal cannula with inspired oxygen fraction 1.

Intervention Type DEVICE

Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* elective flexible bronchoscopy

Exclusion Criteria

* admitted in Neonatal intensive care
* previous respiratory support: oxygen any device, non invasive or invasive ventilation
* patient who may benefit with continuous positive pressure during procedure
Minimum Eligible Age

29 Days

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Son Espases

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Artur sharluyan, MD

Role: PRINCIPAL_INVESTIGATOR

Ib-salut

Sebastian Sailer, MD

Role: STUDY_DIRECTOR

Ib-salud

Francisco de Borja Osona Rodriguez, PhD

Role: STUDY_CHAIR

Ib-salud

References

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Sharluyan A, Osona B, Frontera G, Brandstrup KB, Figuerola J, Sanz-Ruiz I, Salas A, Garrido B, Eva CG, Fernandez A, Pena-Zarza JA, Gil JA, Bover-Bauza C, Sailer S. High flow nasal cannula versus standard low flow nasal oxygen during flexible bronchoscopy in children: A randomized controlled trial. Pediatr Pulmonol. 2021 Dec;56(12):4001-4010. doi: 10.1002/ppul.25655. Epub 2021 Sep 10.

Reference Type DERIVED
PMID: 34506689 (View on PubMed)

Other Identifiers

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IB 3150/16 PI

Identifier Type: -

Identifier Source: org_study_id

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