UMIN-CTR Clinical Trial

Basic information
Public title	Incidence of pulmonary complications with prophylactic use of high-flow nasal cannula after pediatric cardiac surgery
Acronym	Prophylactic high-flow nasal cannula study
Scientific Title	Incidence of pulmonary complications with prophylactic use of high-flow nasal cannula after pediatric cardiac surgery
Scientific Title:Acronym	Prophylactic high-flow nasal cannula study
Region	Japan

Condition
Condition	Patients after pediatric cardiac surgery
Classification by specialty	Anesthesiology Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the incidence of pulmonary complications after pediatric cardiac surgery under the use of prophylactic high-flow nasal cannula
Basic objectives2	Others
Basic objectives -Others	To investigate pulmonary complications (Atelectasis, acute respiratory failure) after pediatric cardiac surgery under the use of 24hours high-flow nasal cannula therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome is the incidences of PPCs within 48 hours after extubation. PPCs are defined as the combination of atelectasis diagnosed by chest radiography and acute respiratory failure. Radiologist measures atelectasis by chest radiography at 1 and 2 postextubation days. Investigator diagnoses ARF at 1 and 2 postextubation day. Definition of respiratory failure 1 Increased respiratory rate (RR) for their age+The use of accessory respiratory muscle RR>50 breath per minute (<1 year old) RR>40 breath per minute (1-4 years ol0 2 Hypoxemic acute respiratory failure (type 1) PaO2<60 mmHg SaO2<90% (with FiO2>0.5) 3 Hypercapnic acute respiratory failure (type 2) pH<7.35 with PaCO2>50 mmHg 4 Mix form of acute respiratory failure Prophylactic use of HFNC therapy might have the potential to reduce the incidence of PPCs following extubation after pediatric cardiac surgery. To investigate this hypothesis, we set PPCs incidence less than 10% as a threshold of a effectiveness of prophylactic HFNC therapy on the basis of the reintubation rate in children underwent cardiac surgery in previous reports (6 to 9%)
Key secondary outcomes	Reintubation less than 48hours Completion rate of 24-hours HFNC therapy Length of ICU stay PaO2 / FiO2 (post-extubation periods) High-flow nasal cannula related adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	HFNC (Optiflow; Fisher and Paykel Healthcare Ltd, Auckland, New Zealand) therapy is prophylactically commenced just after extubation with 2L / kg / min of flow, 37 degrees of temperature with humidifier and adequate fraction of inspiratory oxygen (FIO2) to achieve target oxygen saturation >94%. We choose nasal cannula size according to child's weight and nasal size. HFNC will be continued for 24-hours after extubation if intolerance does not occurred. If patients are not tolerant to HFNC treatment with flow of 2L / kg / min, we reduce flow rate of HFNC to 1 L /kg /min. If intolerance occurred in flow rate of 1L / kg / min, we reduce flow rate of HFNC to less than 1 L /kg /min or change HFNC therapy to conventional oxygen therapy such as facemask and nasal cannula. There is no limitation of oxygen therapy after 24-hours of intervention periods.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	0 years-old <=
Age-upper limit	4 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients after pediatric cardiac surgery (Total repair)
Key exclusion criteria	cyanosis congenital heart disease tracheotomy facial deformity unplanned extubation
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naohiro Shioji
Organization	Okayama university hospital
Division name	department of critical care
Zip code
Address	2-5-1 sikatatyou kitaku okayamasi
TEL	086-235-7778
Email	snaohiro116@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Naohiro Shioji
Organization	Okayama university hospital
Division name	department of critical care
Zip code
Address	2-5-1 sikatatyou kitaku okayamasi
TEL	086-235-7778
Homepage URL
Email	snaohiro116@gmail.com

Sponsor
Institute	Okayama university hospital
Institute
Department

Funding Source
Organization	Notaplicauble
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 11 Month 29 Day
Date of IRB	2017 Year 01 Month 17 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 01 Day
Last modified on	2020 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028700