UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053260 |
|---|---|
| Receipt number | R000060711 |
| Scientific Title | Optimizing flow rate of high-flow nasal cannula using peak inspiratory flow during spontaneous breathing trial for post-extubation pediatric populations |
| Date of disclosure of the study information | 2024/01/20 |
| Last modified on | 2025/01/06 12:38:50 |
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Basic information
Public title
Optimizing flow rate of high-flow nasal cannula using peak inspiratory flow during spontaneous breathing trial for post-extubation pediatric populations
Acronym
Optimizing flow rate of high-flow nasal cannula using peak inspiratory flow during spontaneous breathing trial for post-extubation pediatric populations
Scientific Title
Optimizing flow rate of high-flow nasal cannula using peak inspiratory flow during spontaneous breathing trial for post-extubation pediatric populations
Scientific Title:Acronym
Optimizing flow rate of high-flow nasal cannula using peak inspiratory flow during spontaneous breathing trial for post-extubation pediatric populations
Region
| Japan |
Condition
Condition
pediatric patient
Classification by specialty
| Medicine in general | Vascular surgery | Pediatrics |
| Cardiovascular surgery | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
High-flow nasal cannula oxygen therapy (HFNC) is an oxygen therapy that delivers heated and humidified oxygen at a constant concentration (FIO2: Fraction of inspiratory oxygen, 0.21-1.0) through a wide-bore nasal cannula at high flow rates (up to 60 L/min). The potential benefits include improvement of airway mucociliary clearance, reduction of upper airway resistance, clearance of anatomical dead space, and positive airway pressure. In healthy children, during quiet tidal breathing, the displacement of the two compartments consisting of the chest wall and abdominal wall is coordinated. However, in cases of increased inspiratory resistance, obstructive lung disease, or decreased lung compliance, resulting in thoraco-abdominal asynchrony and increased work of breathing. HFNC has been reported to improve thoraco-abdominal synchrony and decrease breathing frequency, thereby reducing work of breathing. However, the effectiveness of HFNC varies depending on the flow rate settings. We focused on 1. the optimal flow rate of HFNC improves respiratory patterns, and 2. setting the flow rate of HFNC according to the patient's inspiratory flow may be potentially beneficial for respiratory support. We hypothesized that in pediatric patients, setting the flow rate of HFNC based on the peak inspiratory flow (PIF) during a SBT before extubation could be beneficial for respiratory support. Respiratory inductance plethysmography (RIP) is a non-invasive monitoring device that qualitatively and quantitatively measures a series of respiratory movements as amplitudes by attaching two elastic transducers to the chest and abdominal wall. By using this device, the effectiveness of HFNC at different flow rates can be objectively evaluated, we consider the optimal flow rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase angle
We collect data during SBT before extubation and during HFNC at different flow settings after extubation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1. After confirming that the SBT initiation criteria are met, thoraco-abdominal movement is measured with respiratory inductive plethysmography using two elastic transducers placed around the thorax and abdomen to record changes in cross-sectional area.
2. SBT should be performed for 30 minutes in Pressure Support Ventilation (PSV) mode with a PS setting of 5 cmH2O and a PEEP setting of 5 cmH2O.
3. Beginning 20 minutes after the SBT, measure the average Peak Inspiratory Flow (PIF) for a stable 5 consecutive breaths and record the following clinical data.
4. After extubation, HFNC was applied. The flow rate of HFNC is randomly selected from the average PIF, 1 L/kg/min and 2 L/kg/min. However, if the average PIF exceeds 3 L/kg/min, 3 L/kg/min is used as the average PIF.
5. For each flow rate setting, set the observation period to 10 minutes and record the following data for the last 1 minute of observation.
6. If the following discontinuation criteria are met, stop the trial and continue standard of care.
Interventions/Control_2
The RIP consists of two elastic belts with built-in insulated coils. One belt is wrapped around the chest at the level of the nipple and the other is wrapped around the abdominal wall at the level of the umbilicus. The movements of the rib cage and the abdomen were evaluated by the changes in the inductance of the transducers. During invasive ventilation, we calibrate the respiratory inductive plethysmography by means of the qualitative diagnostic calibration technique as described by Sackner et al. To evaluate thoraco-abdominal synchrony, create a retrospective Konno-Mead diagram and calculate the following indices.
Interventions/Control_3
Clinical data:
Before extubation (during SBT):
Blood pressure, heart rate, SpO2, breathing frequency, chest and abdominal movements evaluated by Inductotrace, peak inspiratory flow (PIF),
P 0.1 (airway occlusion pressure), NIF (maximum inspiratory negative pressure), tidal volume, arterial blood gas analysis
After extubation (during HFNC):
Blood pressure, heart rate, SpO2, breathing frequency, chest and abdominal movements evaluated by Inductotrace, patient tolerability,
arterial blood gas analysis
Discontinuation Criteria:
Acidosis pH < 7.3 with PaCO2 > 50mmHg, requires prone therapy, lateral positioning or other drainage maneuvers, intolerance, severe upper airway obstruction, any other situation deemed dangerous by the clinician.
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
| Not applicable |
Age-upper limit
| 2 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Infant under 2 years old who has undergone invasive ventilation for more than 24 hours
Body weight between 2 kg and 15 kg
Scheduled for SBT (Spontaneous Breathing Trial) before extubation
Potential indications for HFNC (High-Flow Nasal Cannula) after extubation (Requires oxygen administration when SpO2 < 95%, breathing frequency > 60 breaths per minute, abnormal breathing patterns such as retractive breathing or paradoxical breathing, respiratory insufficiency from cardiac surgery)
Key exclusion criteria
Difficulty fitting HFNC (nasal congestion, facial trauma, intolerance)
Difficulty fitting transducer (trunk trauma, burns, intolerance)
Combination of HFNC with NO inhalation therapy
Hemodynamic instability (mean blood pressure: <40 mmHg in neonates, <50 mmHg in infants)
Severe hypoxemia (PaO2: Partial pressure of arterial oxygen/FiO2 ratio <150 in non-cyanotic heart disease)
Severe acidemia (pH < 7.20)
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Taiga |
| Middle name | |
| Last name | Itagaki |
Organization
Tokushima University Hospital
Division name
Emergency and Disaster Medicine
Zip code
770-8503
Address
2-50-1, Kuramoto, Tokushima, Japan
TEL
088-631-3111
tigerusan@gmail.com
Public contact
Name of contact person
| 1st name | Taiga |
| Middle name | |
| Last name | Itagaki |
Organization
Tokushima University Hospital
Division name
Emergency and Disaster Medicine
Zip code
770-8503
Address
2-50-1, Kuramoto, Tokushima, Japan
TEL
088-631-3111
Homepage URL
tigerusan@gmail.com
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1, Kuramoto, Tokushima, Japan
Tel
088-633-8512
first-ec@tokushima-u.ac.jp
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
| 2024 | Year | 01 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2024 | Year | 01 | Month | 04 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060711
