Effect of High Flow Nasal Cannula on Oxygenation During Urodynamic Study in Pediatric Population

NCT ID: NCT04152733

Last Updated: 2020-04-22

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-23

Study Completion Date

2021-12-30

Brief Summary

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To evaluate the effect of high flow nasal cannula for prevention of hypoxia during deep sedation in pediatric population

Detailed Description

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Conditions

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Desaturation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

Children in the control group receive oxygen via conventional nasal cannula during deep sedation. Oxygen flow is determined to set the fraction of inspired oxygen of 50%.

Group Type NO_INTERVENTION

No interventions assigned to this group

High flow (HF) group

Children in the HF group receive oxygen via high flow nasal cannula during deep sedation. Fraction of inspired oxygen is set to 50%.

Group Type EXPERIMENTAL

High flow nasal cannula

Intervention Type DEVICE

Oxygen is supplied via high flow nasal cannula. Heated air (2L/kg/min) is administered using Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand).

Interventions

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High flow nasal cannula

Oxygen is supplied via high flow nasal cannula. Heated air (2L/kg/min) is administered using Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Children aged \<7 years
* ASA class I, II

Exclusion Criteria

* Respiratory disease
* Pneumothorax
* Increased ICP
* Nasal bleeding
* Previous airway surgery
* Trauma
* Pulmonary hypertension
Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Tae Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jin-Tae Kim, MD, PhD

Role: CONTACT

82-2-2072-3661

Facility Contacts

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Jin-Tae Kim, Pf.

Role: primary

+82-2-2072-3295

Other Identifiers

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H1910-038-1068

Identifier Type: -

Identifier Source: org_study_id

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