UMIN-CTR Clinical Trial

Public title

External Validation of HACOR Score and Updated HACOR Score in Type 1 Acute Respiratory Failure Patients Undergoing High Flow Nasal Therapy (HFNT) and Development of a New Predictive Model

Acronym

External Validation of HACOR Score and Updated HACOR Score in Type 1 Acute Respiratory Failure Patients Undergoing High Flow Nasal Therapy (HFNT) and Development of a New Predictive Model

Scientific Title

External Validation of HACOR Score and Updated HACOR Score in Type 1 Acute Respiratory Failure Patients Undergoing High Flow Nasal Therapy (HFNT) and Development of a New Predictive Model

Scientific Title:Acronym

External Validation of HACOR Score and Updated HACOR Score in Type 1 Acute Respiratory Failure Patients Undergoing High Flow Nasal Therapy (HFNT) and Development of a New Predictive Model

Region

Japan

Condition

Based on the provided text, here is the English translation of the inclusion and exclusion criteria:
Inclusion Criteria:

Patients aged 18 years or older with acute type 1 respiratory failure using HFNT
Exclusion Criteria:
Subjects who meet any of the following criteria will not be included in this study.

Patients with respiratory failure due to trauma (patients with trauma registered as the main diagnosis)
Patients diagnosed with COVID-19 at the time of hospital admission
Patients using HFNT after weaning from mechanical ventilation or after noninvasive positive pressure ventilation
Patients with "Do Not Intubate" status at the time of HFNT initiation

Classification by specialty

Emergency medicine

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to externally validate the HACOR score and Updated HACOR score in patients with type 1 acute respiratory failure undergoing HFNT, compare them with the ROX score, and develop a new, easy-to-understand predictive model for treatment failure.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Primary Endpoint: Treatment failure within 24 hours of HFNT initiation (endotracheal intubation, transition to noninvasive positive pressure ventilation, or death)

Key secondary outcomes

Outcome at ICU discharge
28-day mortality
Outcome at hospital discharge
Length of hospital stay
Length of ICU stay
Endotracheal intubation within 48 hours
Endotracheal intubation during the observation period

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion Criteria:

Patients aged 18 years or older with acute type 1 respiratory failure using HFNT

Acute type 1 respiratory failure is defined as a condition that meets any of the following criteria: arterial oxygen tension (PaO2) of 60 Torr or less, or arterial oxygen saturation (SaO2) of 90% or less under room air inhalation. Alternatively, if a respiratory disorder is present and arterial blood gases cannot be measured under room air inhalation, central cyanosis is observed.

Key exclusion criteria

Exclusion Criteria:
Subjects who meet any of the following criteria will not be included in this study.

Patients with respiratory failure due to trauma (patients with trauma registered as the main diagnosis)
Patients diagnosed with COVID-19 at the time of hospital admission
Patients using HFNT after weaning from mechanical ventilation or after noninvasive positive pressure ventilation
Patients with "Do Not Intubate" status at the time of HFNT initiation

Target sample size

300

Name of lead principal investigator

1st name	Hiromu
Middle name
Last name	Okano

Organization

St. Luke's International Hospital

Division name

Department of Critical Care Medicine

Zip code

1048560

Address

9-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan.

TEL

0335445151

Email

okano.hiromu.a5@luke.ac.jp

Name of contact person

1st name	Hiromu
Middle name
Last name	Okano

Organization

St. Luke's International Hospital

Division name

Department of Critical Care Medicine

Zip code

1048560

Address

9-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan

TEL

0335445151

Homepage URL

Email

okano.hiromu.a5@luke.ac.jp

Institute

St. Luke's International Hospital

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

St. Luke's International Hospital

Address

9-1 Akashi-cho, Chuo-ku, Tokyo 104-8560, Japan

Tel

0335445151

Email

okano.hiromu.a5@luke.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

09

Month

01

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

05

Month

01

Day

Date of IRB

Anticipated trial start date

2024

Year

09

Month

01

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Research Design

This study is planned to be conducted as a multicenter, retrospective observational study.

Research Procedure

(1) Overview of Research Methods

This study will target patients aged 18 years or older who were hospitalized with acute type 1 respiratory failure and treated with HFNT.

The subjects will be divided into those who successfully weaned from HFNT and those who were eventually intubated among those managed with HFNT.

(2) Research Design

This is a multicenter, retrospective observational study, and cases from April 1, 2020, to March 31, 2024, will be extracted from electronic medical records.

(3) Evaluation Items and Methods

Categorical data will be presented as numbers and ratios and compared using Fisher's exact test.

Handling of missing data: Multiple imputation method will be used.

Data will be collected at the closest time points to 2, 6, 12, 18, 24, and 48 hours after HFNT application.

Based on medical record information, PaO2/FiO2, respiratory rate, and blood gas analysis data will be collected, and the HACOR score and Updated HACOR score will be calculated.
In case of intubation, the closest point immediately before intubation: Closest within 24 hours before intubation. If not available, it will be treated as missing data.

Analysis Method

The subjects will be divided into those who successfully weaned from HFNT and those who were eventually intubated among those managed with HFNT.

<External Validation and Comparison>

Using HFNT failure as the outcome, the HACOR score, Updated HACOR score, and ROX score will be treated as continuous exposure variables, and logistic regression will be performed. Discrimination will be shown using receiver operating characteristic curves and summarized using the area under the curve and 95% confidence intervals.

Registered date

2024

Year

05

Month

11

Day

Last modified on

2024

Year

05

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062103