Weaning Protocol for High Flow Nasal Cannula Oxygen Therapy

NCT ID: NCT03845244

Last Updated: 2024-04-18

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-24

Study Completion Date

2024-03-31

Brief Summary

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High flow nasal cannula oxygen therapy has been widely used in critically ill patients. Despite effectiveness of high flow nasal cannula as a treatment, optimal methods to withdrawal high flow nasal cannula after recovery from preexisting conditions has not been investigated to date. In this study, we will evaluate the efficacy and safety of three different weaning methods in patients with high flow nasal cannula oxygen therapy.

Detailed Description

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Comparison of three weaning strategies: flow reduction first versus fraction of inspired oxygen (FiO2) first versus simultaneous reduction

Conditions

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High Flow Nasal Cannula Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Flow reduction first group

Flow reduction first -\> FiO2 reduction -\> conventional oxygen therapy

Group Type ACTIVE_COMPARATOR

Flow reduction first

Intervention Type DEVICE

-10L/min q 1hr

FiO2 reduction first group

FiO2 reduction first -\> flow reduction -\> conventional oxygen therapy

Group Type ACTIVE_COMPARATOR

FiO2 reduction first

Intervention Type DEVICE

\- 0.1 q 1hr

Simultaneous reduction group

Simultaneous (Flow and FiO2) reduction -\> conventional oxygen therapy

Group Type ACTIVE_COMPARATOR

Simultaneous (flow and FiO2) reduction

Intervention Type DEVICE

-10L/min and -0.1 q 1hr

Interventions

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Flow reduction first

-10L/min q 1hr

Intervention Type DEVICE

FiO2 reduction first

\- 0.1 q 1hr

Intervention Type DEVICE

Simultaneous (flow and FiO2) reduction

-10L/min and -0.1 q 1hr

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The patients applying high flow nasal cannula and satisfying the following weaning criteria.

1. Patient who has recovered from the underlying condition
2. No signs of respiratory distress like agitation, diaphoresis or anxiety
3. Arterial pH ≥ 7.35, SpO2 \> 90% on FiO2 ≤ 0.5
4. Respiratory rate ≤ 25/min, Heart rate ≤120/min, Systolic blood pressure ≥ 90mmHg

Exclusion Criteria

* Severe hypercapnia (pH \<7.25)
* Respiratory arrest requiring tracheal intubation
* Cardiac arrest, acute coronary syndrome or life threatening arrhythmias
* Failure of more than two organs
* Recent trauma or burns of the neck and face
* Non- cooperation
* Pregnancy
* Refusal of treatment
Minimum Eligible Age

18 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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Eun Sun Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eun Sun Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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Kim MC, Lee YJ, Park JS, Cho YJ, Yoon HI, Lee CT, Lee JH, Kim ES. Simultaneous reduction of flow and fraction of inspired oxygen (FiO2) versus reduction of flow first or FiO2 first in patients ready to be weaned from high-flow nasal cannula oxygen therapy: study protocol for a randomized controlled trial (SLOWH trial). Trials. 2020 Jan 14;21(1):81. doi: 10.1186/s13063-019-4019-7.

Reference Type DERIVED
PMID: 31937322 (View on PubMed)

Other Identifiers

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B-1809-492-006

Identifier Type: -

Identifier Source: org_study_id

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