High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery

NCT04451057 | Recruiting DMC

• 1 other identifier: OSACA CATS
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

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".

Conditions

Pediatric Patients After Cardiothoracic Surgery

Keywords

high flow nasal cannula; conventional oxygen therapy; treatment failure after extubation

Outcome Measures

Primary Outcomes (1)

• the rate of"escalation of care due to treatment failure" within 72 hours after extubation

  Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.

Secondary Outcomes (25)

• non event rate within 72 hours after extubation

  Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.

• peripheral oxygen saturation

  Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.

• arterial blood gas

  Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.

• arterial blood gas

  Final outcome measure is assessed when patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.

• arterial blood gas

  Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed before extubation,1 hour,12 hours,24 hours,48 hours and 72 hours after extubation.

Study Arms (2)

high flow nasal nasal cannula

EXPERIMENTAL

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

Device: high flow nasal cannula therapy

low flow nasal cannula

ACTIVE COMPARATOR

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

Device: low flow nasal cannula therapy

Interventions

high flow nasal cannula therapy DEVICE

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

Also known as: high flow nasal cannula oxygen therapy

high flow nasal nasal cannula

low flow nasal cannula therapy DEVICE

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

Also known as: conventional oxygen therapy

low flow nasal cannula

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osaka University: lead
• Osaka Women's and Children's Hospital: collaborator
• Hyogo Prefectural Kobe Children's Hospital: collaborator
• Osaka City General Hospital: collaborator
• Aichi Children's Health and Medical Center: collaborator
• National Center for Child Health and Development: collaborator

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, Osaka University

Osaka, Japan

RECRUITING

Study Officials

• Takeshi Yoshida, MDPhD

  Department of Anesthesiology and Intensive Care Medicine, Osaka University

  STUDY CHAIR

Central Study Contacts

Takeshi Yoshida, MDPhD

CONTACT

+81668795820; takeshiyoshida@hp-icu.med.osaka-u.ac.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind .Participants and their legal representatives are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: control group:conventional oxygen therapy interventional group:high flow nasal cannula

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: June 30, 2020
• Study Start: August 11, 2020
• Primary Completion: February 20, 2024
• Study Completion: June 30, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)