Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients

NCT ID: NCT04852432

Last Updated: 2024-02-23

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

RECRUITING

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-27

Study Completion Date

2024-12-30

Brief Summary

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The investigators evaluate the efficacy and safety of routine administration of oxygen during moderate or deep sedation in pediatric patients. In addition, in terms of efficacy and safety, oxygen administration via nasal prong and high flow nasal cannula will be compared.

Detailed Description

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Conditions

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Pediatric Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

Nasal prong is applied, but sedation is performed without oxygen administration.

Group Type NO_INTERVENTION

No interventions assigned to this group

Low flow group

Oxygen administration by nasal cannula

Group Type EXPERIMENTAL

nasal prong

Intervention Type DEVICE

Oxygen is administered via nasal prong

High flow group

Oxygen is administered at a rate of 2L/kg/min using an Optiflow device

Group Type EXPERIMENTAL

high flow nasal cannula

Intervention Type DEVICE

The heated air is administered at a rate of 2L/kg/min using an Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand). Inhalation oxygen concentration starts with 50%.

Interventions

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high flow nasal cannula

The heated air is administered at a rate of 2L/kg/min using an Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand). Inhalation oxygen concentration starts with 50%.

Intervention Type DEVICE

nasal prong

Oxygen is administered via nasal prong

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Children under the age of 18 who undergo moderate-deep sedation

Exclusion Criteria

* Respiratory failure patients
* Increased intracranial pressure
* Recent massive nasal bleeding
* History of airway surgery
* Complete nasal obstruction
* Pulmonary hypertension
* Skull base fracture
Maximum Eligible Age

17 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

02-2072-3661 ext. 82

Facility Contacts

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Jin-Tae Kim, Pf.

Role: primary

+82-2-2072-3295

References

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Lee JH, Ko HJ, Park JB, Ji SH, Kim JT. Oxygen Supplementation in Pediatric Sedation: Prospective, Multicenter, Randomized Controlled Trial. Anesthesiology. 2025 Jul 1;143(1):132-141. doi: 10.1097/ALN.0000000000005500. Epub 2025 Apr 11.

Reference Type DERIVED
PMID: 40215365 (View on PubMed)

Other Identifiers

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H2103-095-1205

Identifier Type: -

Identifier Source: org_study_id

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