The Efficiency of HHHFNC Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in RCC

NCT ID: NCT04564859

Last Updated: 2020-09-25

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to assess the efficacy of Heated Humidified High-Flow Nasal Cannula compared with noninvasive positive-pressure ventilation in the prevention of extubation failure in patients with prolonged mechanical ventilation.

Detailed Description

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There have been many clinical trials comparing the role of Heated Humidified High-Flow Nasal Cannula or Noninvasive positive pressure ventilation in the prevention of extubation failure.

These review all have similar results summarized here:

Compared with Noninvasive positive pressure ventilation, Heated Humidified High-Flow Nasal Cannula provides better patient comfort, fewer oxygen desaturation episodes, lower likelihood of interface displacement, and, lower reintubation rate than Noninvasive positive pressure ventilation.

However, most of these clinical trials focused on participants experiencing acute respiratory failure.

Investigators of this study want to find something difference between oh these two groups.

Conditions

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Critically Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Noninvasive Ventilation group

Noninvasive Ventilation group initial setting: Insp. Pressure:12 \~ 16 centimeter of water Exp. Pressure : 4 \~ 6 centimeter of water FiO2:Keep oxygen saturation measured by pulse oximeter:\> 92% By condition, gradually tap 2\~3 centimeter of water inspiratory positive airway pressure Keep Tidal volume:6\~10 ml/kg

Group Type EXPERIMENTAL

Heated Humidified High-Flow Nasal Cannula

Intervention Type DEVICE

Participants using of invasive ventilator more than 14 days, maybe considered transferred to the Respiratory Care Center(RCC), participants enrolled to this study and also written informed consent from participants or their family; After extubation, the difficult weaning patients were allocated to two treatment groups, and randomly assigned to Heated Humidified High-Flow Nasal Cannula or Noninvasive Ventilation devices.

Heated Humidified High-Flow Nasal Cannula group

Heated Humidified High-Flow Nasal Cannula group initial setting: Flow setting: 50 L/m FiO2:Keep oxygen saturation measured by pulse oximeter \> 92% temperature:37 ℃ By condition, gradually tap Flow 5 L/m

Group Type ACTIVE_COMPARATOR

Heated Humidified High-Flow Nasal Cannula

Intervention Type DEVICE

Participants using of invasive ventilator more than 14 days, maybe considered transferred to the Respiratory Care Center(RCC), participants enrolled to this study and also written informed consent from participants or their family; After extubation, the difficult weaning patients were allocated to two treatment groups, and randomly assigned to Heated Humidified High-Flow Nasal Cannula or Noninvasive Ventilation devices.

Interventions

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Heated Humidified High-Flow Nasal Cannula

Participants using of invasive ventilator more than 14 days, maybe considered transferred to the Respiratory Care Center(RCC), participants enrolled to this study and also written informed consent from participants or their family; After extubation, the difficult weaning patients were allocated to two treatment groups, and randomly assigned to Heated Humidified High-Flow Nasal Cannula or Noninvasive Ventilation devices.

Intervention Type DEVICE

Other Intervention Names

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Noninvasive Ventilation

Eligibility Criteria

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Inclusion Criteria

* Age: Over 20 years of age
* the requirement of at least six hours of mechanical ventilation per day for at least 14 consecutive days

Exclusion Criteria

* Pregnancy
* Status post tracheostomy
* Neuromuscular diseases
* Signed "do not resuscitate" order
* Unplanned extubation
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fu Jen Catholic University

OTHER

Sponsor Role collaborator

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chen-Chun Lin, MD

Role: STUDY_CHAIR

Shin Kong Wu Ho-Su Memorial Hospital

References

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Tseng CW, Chao KY, Wu HL, Lin CC, Hsu HS. Effectiveness of high-flow nasal cannulae compared with noninvasive positive-pressure ventilation in preventing reintubation in patients receiving prolonged mechanical ventilation. Sci Rep. 2023 Mar 22;13(1):4689. doi: 10.1038/s41598-023-31444-8.

Reference Type DERIVED
PMID: 36949116 (View on PubMed)

Other Identifiers

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SKH-8302-106-NDR-05

Identifier Type: -

Identifier Source: org_study_id

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