UMIN-ICDS Clinical Trial

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

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

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

Primary outcomes

Phase angle
We collect data during SBT before extubation and during HFNC at different flow settings after extubation.

Key secondary outcomes

Study type

Interventional

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

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

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

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

Email

tigerusan@gmail.com

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

Email

tigerusan@gmail.com

Institute

Tokushima University

Institute

Department

Personal name

Organization

nothing

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Ethics Committee of Tokushima University Hospital

Address

2-50-1, Kuramoto, Tokushima, Japan

Tel

088-633-8512

Email

first-ec@tokushima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

01

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2024

Year

01

Month

04

Day

Last modified on

2024

Year

01

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060711