High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery

NCT ID: NCT04451057

Last Updated: 2024-07-08

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

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-11

Study Completion Date

2024-06-30

Brief Summary

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High flow nasal cannula(HFNC) ventilation can provide such effects as wash-out effect of the carbon dioxide inside the anatomical dead space,some level of continuous airway pressure and humidified oxygen gases.

Therefore because of its physiological benefits, it has been reported that HFNC can reduce "treatment failure" after extubation in pediatric patients like preterm babies,or infants who suffer from bronchitis.

However there is no evidence showing that HFNC can reduce "treatment failure" after extubation in pediatric patients after cardiothoracic surgery.

This multi-center randomized controlled trial (RCT) involving pediatric patients after cardiothoracic surgery will be conducted to determine whether HFNC,compared with conventional oxygen therapy,after extubation can reduce the rate of"escalation of care due to treatment failure".

Detailed Description

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The multi-center RCT will enroll 380 pediatric patients after cardiothoracic surgery from the Intensive Care Units (ICUs) in Japan.Informed consent will be obtained from the their parents or legally representatives.They will receive postoperative standard care in ICU and spontaneous breathing test(SBT).If SBT will be done successfully,they will be extubated.Just before extubation,they will be divided randomly into the intervention group or the control group.After randomization,they will be extubated.After extubation,the intervention group will receive HFNC therapy,while the control group will receive conventional oxygen therapy.The flow in the intervention group will surely be maintained to be high,while the flow in control group will surely be less than 2 liter/min.In both groups,outcome measure will be assessed within 72 hours after extubation,or during ICU stay.

Conditions

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Pediatric Patients After Cardiothoracic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

control group:conventional oxygen therapy interventional group:high flow nasal cannula
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single blind .Participants and their legal representatives are blinded.

Study Groups

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high flow nasal nasal cannula

Patients allocated for this arm are received high flow nasal cannula therapy after extubation.

Group Type EXPERIMENTAL

high flow nasal cannula therapy

Intervention Type DEVICE

Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization

low flow nasal cannula

Patients allocated for this arm are received conventional oxygen therapy after extubation.

Group Type ACTIVE_COMPARATOR

low flow nasal cannula therapy

Intervention Type DEVICE

Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization

Interventions

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high flow nasal cannula therapy

Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization

Intervention Type DEVICE

low flow nasal cannula therapy

Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization

Intervention Type DEVICE

Other Intervention Names

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high flow nasal cannula oxygen therapy conventional oxygen therapy

Eligibility Criteria

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Inclusion Criteria

* pediatric patients younger than two years old after cardiothoracic surgery
* pediatric patients who have been ventilated for more than 12 hours after surgery

Exclusion Criteria

* patients with tracheostomy
* patients with do-not-resuscitate (DNR)
* patients who have be treated by noninvasive positive pressure ventilation or high flow nasal cannula before surgery
* patients who undergo unplanned extubation
* patients who have withdrawn consent from their legal guardian
* patients who don't need oxygen therapy
* patients who are planned to receive treatment with noninvasive positive pressure ventilation after extubation
* patients who are planned to inhale nitric oxide(NO) after extubation
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Osaka Women's and Children's Hospital

UNKNOWN

Sponsor Role collaborator

Hyogo Prefectural Kobe Children's Hospital

OTHER

Sponsor Role collaborator

Osaka City General Hospital

OTHER

Sponsor Role collaborator

Aichi Children's Health and Medical Center

UNKNOWN

Sponsor Role collaborator

National Center for Child Health and Development

UNKNOWN

Sponsor Role collaborator

Osaka University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Takeshi Yoshida, MDPhD

Role: STUDY_CHAIR

Department of Anesthesiology and Intensive Care Medicine, Osaka University

Locations

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Department of Anesthesiology and Intensive Care Medicine, Osaka University

Osaka, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Takeshi Yoshida, MDPhD

Role: CONTACT

+81668795820

Facility Contacts

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Takeshi Yoshida, MDPhD

Role: primary

+81668795820

Other Identifiers

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OSACA CATS

Identifier Type: -

Identifier Source: org_study_id

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