UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025494 |
|---|---|
| Receipt number | R000028700 |
| Scientific Title | Incidence of pulmonary complications with prophylactic use of high-flow nasal cannula after pediatric cardiac surgery |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/07/12 07:12:41 |
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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
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
snaohiro116@gmail.com
Sponsor or person
Institute
Okayama university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028700
